Full opinion text
MEMORANDUM OPINION GOLDBERG, District Judge. This multidistrict litigation raises the following question: can a pharmaceutical' company marketing brand-name prescription drugs be subject to antitrust liability for engaging in what has been referred to as a “product hopping” scheme? Plaintiffs urge that the answer to this question is “yes,” and allege that as the period of exclusivity on the brand-name drug, Su-boxone, expired and generic versions of that drug were to become available, Reck-itt Benekiser, Inc. effectuated inconsequential changes to the Suboxone dosage form to prevent competition from generic formulations. More specifically, Plaintiffs, the Direct Purchasers of Suboxone (“Direct Purchasers”) and the End Payors of Suboxone (“End Payors”) claim that Reck-itt and its affiliates (“Reckitt”) switched from sublingual Suboxone tablets to a sub-lingual Suboxone film for the purpose of stymying generic competition. This switch was allegedly accompanied by Reckitt falsely disparaging the tablet through fabricated safety concerns and ultimately removing Suboxone tablets from the market just as generic Suboxone tablets were able to begin competing. Reckitt is also alleged to have manipulated FDA regulations to delay the entry of generic Subox-one’ onto the market, thereby unlawfully maintaining a monopoly in violation of § 2 of the Sherman Act and state law. According to Plaintiffs, Reekitt’s conduct negatively affected competition and resulted in ongoing overpayments by consumers. Before me is Reekitt’s motion to dismiss which essentially argues that Plaintiffs’ complaint describes nothing more than new product development and marketing. Reckitt is correct that thé development and marketing of new products is typically viewed as procompetitive. However, due to market characteristics unique to the' pharmaceutical industry, I conclude that some of Plaintiffs’ claims do plausibly allege antitrust violations and should survive Defendants’ motions to dismiss. This opinion explains the bases for my ruling. I. FACTUAL AND PROCEDURAL BACKGROUND The facts alleged by Plaintiffs are as follows: Suboxone (Buprenorphine Na-loxone or “BPN/NLX”) is a prescription drug used for the maintenance treatment of opioid dependence. It is the only pharmaceutical on the market that provides maintenance treatment for patients suffering from opioid addiction that can also be prescribed in an office setting for the patient’s home use. All other opioid addiction maintenance treatments, such as methadone, can only be dispensed at a clinic. Suboxone has been approved for home use because it is co-formulated to help prevent abuse, containing both: (1) buprenorphine, an opioid which treats the withdrawal symptoms; and (2) naloxone, an opioid antagonist, which causes the immediate onset of withdrawal symptoms if the product is inappropriately melted and injected. Today, Suboxone has annual sales of over one billion dollars and accounts for 20% of Reckitt’s profits. (DP Compl. ¶¶ 5, 74-77.) Under the Federal Food, Drug and Cosmetic Act (“FDCA”), 21 U.S.C. §§ 301 et seq., a manufacturer that creates a new drug must obtain the approval of the Food and Drug Administration (“FDA”) to sell the drug by filing a New Drug Application (“NDA”). Under the Drug Price Competition and Patent Term Restoration Act, Pub.L. No. 98-417 (1984), commonly known as the Hatch-Waxman Act, certain pioneer drugs can gain periods of exclusivity. However, Hatch-Waxman also simplified the process by which generic manufacturers can compete with brand-name drugs on the market through the filing of an Abbreviated New Drug Application (“ANDA”). For example, Hatch-Waxman eliminated the need for generic manufacturers seeking ANDA approval to duplicate clinical studies that had already been performed by a bioequivalent brand-name drug manufacturer. (Id. at ¶¶ 38-42.) In order for a drug to be deemed bioe-quivalent, the generic product must be shown to deliver the same amount of active ingredient into a patient’s blood stream for the same amount of time as the brand-name drug. ANDA filers demonstrating bioequivalence generally seek to have their product deemed “AB-rated” to the brand-name drug. This rating means that in addition to being bioequiyalent, the two drugs are also pharmaceutically equivalent — which includes such considerations as having the same active ingredient, the same strength, the same route of administration and the same dosage form. A pharmacy may not substitute a generic drug for a brand-name drug unless the generic is AB-rated. (Id. at ¶¶ 42-44.) Competition from low cost AB-rated generic drugs saves consumers billions of dollars a year. When an AB-rated generic drug enters the market, the brand-name company often suffers a rapid, steep decline in sales — on average 80% within the first year. AB-rated generic competition enables direct and indirect purchasers to obtain both the generic drugs and the brand-name drugs at substantially lower prices. (Id. at ¶¶ 9, 51, 55.) The FDA approved Reckitt’s NDA for Suboxone tablets in 2002. Although Reck-itt did not have a patent for Suboxone tablets, it was able to obtain a seven-year period of exclusivity from the FDA because Suboxone was found to be an orphan drug. Reckitt’s period of exclusivity for Suboxone tablets was scheduled to expire on October 8, 2009. (Id. at ¶¶ 78-80.) Plaintiffs allege that Reckitt, knowing its period of exclusivity would soon be over, began developing Suboxone film and obtaining patent protection for this new product. Reckitt’s actions while developing and marketing its new product are described as a “product-hopping scheme” and are alleged to be anticompetitive with the aim of maintaining Reckitt’s monopoly in the Suboxone market. A. Description of Alleged Conduct 1. Product-Hopping: Development of Suboxone Film and the Alleged Destruction of the Tablet Market The NDA for Suboxone film was submitted on October 20, 2008 and was approved August 30, 2010. The patent for Suboxone film — patent 8,017,150 (“the '150 patent”) — expires September 2023. Generic Suboxone tablets cannot be AB-rated to branded Suboxone film due to the differences in,dosage form — that is, sublingual tablet versus sublingual film. Therefore, a pharmacist cannot provide a patient with generic Suboxone tablets when a patient has a prescription for Suboxone film. (Id. at ¶¶ 81, 88.) Plaintiffs allege that there are few differences between Suboxone film and Su-boxone tablets, and that the film is not superior to the tablets. In support of this assertion, Plaintiffs claim that the two products are so similar that Reckitt submitted safety and efficacy studies performed on Suboxone tablets when seeking approval of the Suboxone film NDA. The two products are alleged to have equivalent bioavailability, meaning that the products release the same amount of active ingredients into a patient’s bloodstream. Although Reckitt indicated in its NDA that the film’s individual packaging reduced the risk for accidental pediatric exposure to the drug, Plaintiffs assert that the evidence provided by Reckitt on this issue was flawed. Indeed, Plaintiffs argue that the film may present increased risk for accidental pediatric exposure because the filmstrip dissolves more quickly than the tablet, and therefore may be more difficult for a child to spit out in the event of exposure. Plaintiffs also allege that the film has a higher risk of abuse than the tablets. (Id. at ¶¶ 82-86, Exs. A, B.) Plaintiffs explain that'once the FDA approved the Suboxone film NDA in 2010, Reckitt launched a fraudulent sales and marketing campaign against the tablet for the purpose of diverting sales from the tablet, which would soon face generic competition, to the patent-protected film. Reckitt sales associates allegedly met with physicians and, in addition to promoting Suboxone film, disparaged Suboxone tablets and warned of false safety concerns. It is also alleged that Reckitt publicly announced the removal of Suboxone tablets from the market for these fabricated safety reasons, although it did not actually remove the tablets until six months later— once the generic Suboxone ANDAs obtained FDA approval. Reckitt also reportedly raised the price of its tablets in relation to the film formulation despite the fact that the film was more expensive to manufacture and package. Plaintiffs conclude that Reckitt was successful in its scheme, and had managed to convert 64% of all Suboxone prescriptions from tablet to film by the end of 2012. (Id. at ¶¶ 89-92.) 2. Reckitt Allegedly Delayed ANDA Approvals by Feigning Cooperation in the REMS Process On December 22, 2011, the FDA approved a Risk Evaluation and Mitigation Strategy (“REMS”) performed by Reck-itt on the issue of the risk of pediatric exposure to Suboxone tablets. Through the REMS, the FDA required that Reckitt address pediatric exposures via FDA-approved labeling. (DP Compl. ¶ 99.) Pharmaceutical companies Aetavis, Inc. and Amneal (“the Generics”) filed ANDAs for generic Suboxone tablets in 2009 and May 2011 respectively. On January 6, 2012, the FDA sent all sponsors of pending ANDAs for Suboxone tablets a notification letter stating that all branded and generic Suboxone products would be subject to a Single Shared REMS program (“SSRS”). ANDA filers were directed to contact Reckitt to collaborate on the creation of an SSRS program. The FDA gave a compliance date of May 6, 2012 for the SSRS. Plaintiffs explain that the FDA gave a short turn-around time, assuming that the recently approved REMS performed by Reckitt would simply be amended to add the bioequivalent generic products. (Id. at ¶¶ 98-102.) Plaintiffs allege that Reckitt used the SSRS as a means to undermine and delay generic entry by making unnecessary, unprecedented and unreasonable demands on the generic companies as a condition precedent to Reckitt’s cooperation in the SSRS, despite the fact that such delay tactics are expressly prohibited by 21 U.S.C. § 355-l(f)(8). Reckitt reportedly turned down numerous invitations to participate in meetings with the Generics, and refused to engage in substantive discussions until the Generics agreed to a number of conditions the Generics found unfavorable, including “an upfront agreement that all manufacturers would share the costs of product liability for future potential lawsuits.” It is further alleged that Reckitt refused to share non-public information from its REMS program until its demands were met. (Id. at ¶¶ 105-06.) The Generics complained to the FDA about Reckitt’s alleged delay tactics and a meeting was held on June 18, 2012. The FDA acknowledged during this meeting that it could not compel Reckitt to share its non-public REMS program, and suggested that.the Generics develop a new SSRS without using Reckitt’s information. Although the FDA implored Reckitt and the Generics to work together in good faith and to not attempt to block or delay, Plaintiffs claim that Reckitt’s obstructionist actions continued, and that Reckitt refused to cooperate unless the Generics agreed to provide Reckitt veto authority or a super-majority vote on all issues relating to the SSRS. Two days before the SSRS was submitted, Reckitt allegedly argued for the first time that an important element of the REMS had been omitted and refused to sign the SSRS. Ultimately, the Generics sought a waiver for approval of their Generies-only SSRS on October 3,. 2012. (M at ¶¶ 107-12.) 3. Reckitt Allegedly Files a Sham Citizen Petition and Fraudulently Delays That Filing to Maximize Delay of Generic Tablet Approval Plaintiffs explain that Reckitt publicly announced the withdrawal of Suboxone tablets from the market due to false safety concerns on September 25, 2012, just prior to the Generic REMS waiver request. On that same date, Reckitt filed a Citizen Petition with the FDA for the alleged purpose of blocking approval of the pending Suboxone ANDAs on purported safety grounds. The Petition requested that the FDA take three actions: (1) refrain from approving any BPN/NLX NDA or ANDA for the treatment of opioid addiction that did not include a targeted pediatric exposure education program, a condition not required for branded Suboxone tablets; (2) refrain from approving applications for BPN/NLX for opioid addiction that lacked unit-dose packaging, which was also not a condition for the branded Suboxone tablets; and (3) not approve any BPN/NLX ANDA for addiction treatment until the FDA determined whether Reckitt had discontinued Suboxone tablets for safety reasons. (Id. at ¶¶ 113-15.) Plaintiffs urge that Reckitt’s Citizen Petition was a sham because the FDA had no statutory or regulatory authority to grant much of the relief requested. For example, the FDA has no authority to require ANDA filers to mimic non-approved labeling and REMS materials in order to obtain ANDA approval. Nonetheless, Reckitt requested that ANDA filers seeking approval for generic Suboxone be required to include a pediatric exposure education program that was not part of the FDA-approved REMS or labeling for Suboxone tablets. Further, Reckitt’s request for an FDA investigation into the removal of Su-boxone tablets from the market is alleged to be a sham because Reckitt had not withdrawn Suboxone tablets from the market at the time the request was made. Plaintiffs also argue that Reckitt’s request that all ANDA filers be required to use unit-dose packaging is a sham because Reckitt continued to sell Suboxone tablets in bulk packaging during that time period. Finally, the FDA found that the study in Reckitt’s Citizen Petition — which Reckitt argued supported its unit-dose packaging argument — acknowledged that it had insufficient information from which to draw definitive conclusions. (Id. at ¶¶ 117-31.) In addition to alleging that the Citizen Petition was a sham, Plaintiffs also argue that it included a false certification regarding its timeliness and support. Citizen Petitions require the filer to certify when they first learned, of the issues raised. Reckitt certified that it learned of the risk of accidental pediatric exposure on September 15, 2012 even though its own study indicated that Reckitt had learned of the risk several years earlier. (Id. at ¶¶ 132-40.) The FDA denied Reckitt’s Citizen Petition on February 22, 2013, noting that Reckitt’s announcement that it was withdrawing Suboxone tablets, “given its close alignment with the period in which generic competition for this product was expected to begin, • cannot be ignored.” The FDA further referred Reckitt’s conduct to the Federal Trade Commission (“FTC”) for antitrust investigation. (Id. at ¶¶ 141-43.) Plaintiffs assert that once the Citizen Petition was denied, the FDA immediately granted final approval of the ANDAs of two generic manufacturers, Amneal and Actavis, for generic Suboxone tablets. Three weeks later, on March 18, 2013, Reckitt withdrew branded Suboxone tablets from the market, which Plaintiffs characterize “as a last ditch effort to further coerce the market to switch to the non-improved film product.” (Id. at ¶¶ 143-44.) 4. Alleged Effects of Reckitt’s Scheme Plaintiffs urge that Reckitt’s multifaceted scheme outlined above foreclosed or severely limited generic competition to branded Suboxone. In addition to delaying the Generic’s entry onto the market, Plaintiffs claim that by the time the generic ANDAs were approved, Reckitt had coerced physicians to largely convert to prescriptions for Suboxone film, which cannot be substituted for a generic product. Plaintiffs assert these actions have caused an ongoing antitrust injury to the Direct Purchasers, the End Payors, and the public at large by preventing Generics from meaningfully and efficiently competing with Reckitt. Plaintiffs conclude that these actions were all designed to maintain monopoly profits in violation of the Sherman Act and state law. (Id. at ¶¶ 145-50, 156.) B. Specific Causes of Action The Direct Purchasers seek damages and injunctive relief through the following claims, all of which are alleged to violate § 2 of the Sherman Act: (1) unlawful maintenance of monopoly power through an overarching scheme to prevent or delay generic competition (“Count I”); (2) unlawful maintenance of monopoly power by conversion of the market from tablet to film formulation (“Count II”); (3) unlawful maintenance of monopoly power by intentionally delaying the SSRS process and violating 21 U.S.C. § 355 — 1(f)(8) (“Count III”); (4) unlawful maintenance of monopoly power by filing a sham Citizen Petition (“Count IV”); and (5) unlawful maintenance of monopoly power by fraudulently delaying the filing of the Citizen Petition (“Count V”). (Id. at ¶¶ 166-200.) The End Payors assert the following causes of action: (1) monopolization and monopolistic scheme under state law (listing 29 state statutes) (“Count I”); (2) attempted monopolization under state law (listing 29 state statutes) (“Count II”); (3) unfair and deceptive trade practices under state law (listing 28 state statutes) (“Count III”); (4) injunctive and declaratory relief under § 16 of the Clayton Act for Reckitt’s violations of § 2 of the Sherman Act (“Count IV”); and (5) unjust enrichment under state law (under 48 states and the District of Columbia) (“Count V”). (EP Compl. ¶¶ 163-99.) Reckitt has filed motions to dismiss each of the Plaintiffs’ amended complaints. II. STANDARD OF REVIEW In deciding a motion to dismiss, the court must “accept as true all allegations in the complaint and all reasonable inferences that can be drawn therefrom, and view them in the light most favorable to the non-moving party.” DeBenedictis v. Merrill Lynch & Co., Inc., - 492 F.3d 209, 215 (3d Cir.2007) (quoting Rocks v. City of Philadelphia, 868 F.2d 644, 645 (3d Cir.1989)). Reckitt raises arguments for dismissal under the pleading standards of both Federal Rule of Civil Procedure 8(a) and 9(b) in their motions. A. Pleading under Rule 8(a) Under Rule 8(a), in order to survive a motion to dismiss brought under Federal Rule of Civil Procedure 12(b)(6), a complaint must “contain sufficient factual matter, accepted as true, to ‘state a claim for relief that is plausible on its face.’ ” Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007)). The plausibility standard requires more than a “sheer possibility that a defendant has acted unlawfully.” Id. To determine the sufficiency of a complaint under Twombly and Iqbal, a court must take the following three steps: (1) the court must “tak[e] note of the elements a plaintiff must plead to state a claim;” (2) the court should identify the allegations that, “because they are no more than conclusions, are not entitled to the assumption of truth;” and (3) “where there are well-pleaded factual allegations, a court should assume their veracity and then determine whether they plausibly give rise to an entitlement for relief.” Burtch v. Milberg Factors, Inc., 662 F.3d 212, 221 (3d Cir.2011) (citations omitted). B. Pleading under Rule 9(b) Rule 9(b) provides, “In alleging fraud or mistake, a party must state with particularity the circumstances constituting fraud or mistake. Malice, intent, knowledge, and other conditions of a person’s mind may be alleged generally.” Fed.R.Civ.P. 9(b). The pleadings must be specific enough to “place the defendants on notice of the precise misconduct with which they are charged, and to safeguard defendants against spurious charges of immoral and fraudulent behavior.” Seville Indus. Mach. Corp. v. Southmost Mach. Corp., 742 F.2d 786, 791 (3d Cir.1984). “Rule 9(b) requires, at a minimum, that plaintiffs support their allegations of ... fraud with all of the essential factual background that would accompany the first paragraph of any newspaper story — that is, the who, what, when, where and how of the events at issue.” United States ex rel. Streck v. Allergan, Inc., 894 F.Supp.2d 584, 590-91 (E.D.Pa.2012) (quoting In re Rockefeller Ctr. Props., Inc. Sec. Litig., 311 F.3d 198, 217 (3d Cir.2002)). III. LEGAL ANALYSIS A. Overview-Reckitt’s Motion to Dismiss the Direct Purchasers’ Complaint All of the Direct Purchasers’ claims invoke § 2 of the Sherman Act, which states: “Every person who shall monopolize, or attempt to monopolize, or combine or conspire with any other person or persons, to monopolize any part of the trade or commerce among the several States, or with foreign nations” is guilty of an offense and subject to penalties. 15 U.S.C. § 2. The following are elements of a § 2 monopolization claim: “(1) the possession of monopoly power in the relevant market and (2) the willful acquisition or maintenance of that power as distinguished from growth or development as a consequence of a superior product, business acumen, or historic accident.” United States v. Grinnell Corp., 384 U.S. 563, 570-71, 86 S.Ct. 1698, 16 L.Ed.2d 778 (1966). Simple possession of monopoly power is not enough; a defendant must also engage in exclusionary conduct to run afoul of § 2. Walgreen Co. v. AstraZeneca Pharm. L.P., 534 F.Supp.2d 146, 150 (D.D.C.2008) (quoting Phillip E. Areeda & Herbert Hovenkamp, 3 Antitrust Law § 650a(l) at 67 (rev. ed.1996)). “Exclusionary conduct is ‘that which prevents actual or potential rivals from competing or impairs their opportunities to do so effectively.’ ” Id. “The [Sherman Act] directs itself not against conduct which is competitive, even severely so, but against conduct which unfairly tends to destroy competition itself.” United States v. Microsoft Corp., 253 F.3d 34, 58 (D.C.Cir.2001) (quoting Spectrum Sports, Inc. v. McQuillan, 506 U.S. 447, 458, 113 S.Ct. 884, 122 L.Ed.2d 247 (1993)). The plaintiff bears the burden of demonstrating that a monopolist’s conduct has the requisite anticompetitive effect, and if he is successful, the burden moves to the defendant to demonstrate a procompetitive justification for its conduct. Id. at 58-59 (citing Eastman Kodak Co. v. Image Tech. Servs., Inc., 504 U.S. 451, 483, 112 5.Ct. 2072, 119 L.Ed.2d 265 (1992)). Finally, “if the monopolist’s procompetitive justification stands unrebutted, then the plaintiff must demonstrate that the anti-competitive harm of the conduct outweighs the procompetitive benefit.” Id. Reckitt raises four core arguments for dismissal of the Direct Purchasers’ claims: (1) Count II, relating to the introduction of Suboxone Film, fails because the law presumes that the introduction of new and different products increases competition; (2) Count III, relating to Reckitt’s alleged failure to cooperate during the REMS period, fails because the Supreme Court has unequivocally held that a monopolist has no duty to deal with its competitors; (3) Counts IV and V, relating to Reckitt’s Citizen Petition, should be dismissed because the Citizen Petition was not a sham and did not delay Generic market entry; and (4) Count I, which asserts a claim for the combined effect of Reckitt’s actions, fails because none of the underlying actions violate the antitrust laws, and unsuccessful claims cannot be combined to state a successful one. Each of these arguments is addressed below. B. Count II — Introduction of Suboxone Film Reckitt argues that the introduction of a new product by definition increases competition in the relevant market, and therefore cannot be found to be anticompetitive. Reckitt further asserts that Plaintiffs acknowledged in their complaints that Su-boxone film made improvements to the tablets which are procompetitive, not exclusionary. Finally, Reckitt argues that any harm that would arise from the introduction of a new product is inflicted upon competitors, not competition itself, and therefore is not the type of injury the antitrust laws were created to address. 1. Does the “Product-Hopping” Conduct Alleged Constitute Exclusionary Conduct? “ ‘Anticompetitive conduct’ can come in too many different forms, and is too dependent upon context, for any court or commentator ever to have enumerated all the varieties.” West Penn Allegheny Health Sys., Inc. v. UPMC, 627 F.3d 85, 109 (3d Cir.2010) (quoting LePage’s Inc. v. 3M, 324 F.3d 141, 152 (3d Cir.2003)). “[A]s a general rule, any firm, even a monopolist, may ... bring its products to market whenever and however it chooses.” Steamfitters Local Union No. 420 Welfare Fund v. Philip Morris, Inc., 171 F.3d 912, 925 n. 7 (3d Cir.1999) (quoting Berkey Photo, Inc. v. Eastman Kodak Co., 603 F.2d 263, 286 (2d Cir.1979)). New and improved products are one of the benefits brought about by healthy competition. Abbott Labs. v. Teva Pharm. USA, Inc., 432 F.Supp.2d 408, 420 (D.Del.2006) (citing Berkey Photo, 603 F.2d at 286). Even a monopolist may expand its market share and increase demand for its products through technological innovation, “and such actions are ‘perfectly consistent with the competitive forces that the Sherman Act was intended to foster.’ ” Id. (quoting Foremost Pro Color, Inc. v. Eastman Kodak Co., 703 F.2d 534, 546 (9th Cir.1983)). Because ordinarily innovation will also inflict harm upon competitors, “courts should not condemn a product change ... unless they are relatively confident that the conduct in question is anticompetitive.” Id. at 421 (quoting Herbert Hovenkamp, Mark D. Janis & Mark A. Lemley, IP and Antitrust § 12.1). However, “when the introduction of a new product by a monopolist prevents consumer choice, greater scrutiny is appropriate” and the “basis for judicial deference is removed.” Id. When assessing whether conduct is exclusionary, “it is not necessary that all competition be removed from the market. The test is not total foreclosure, but whether the challenged practices bar a substantial number of rivals or severely restrict the market’s ambit.” United States v. Dentsply Int’l, Inc., 399 F.3d 181, 191 (3d Cir.2005) (citing LePage’s, 324 F.3d at 159-60; Microsoft, 253 F.3d at 69). In support of its argument that Plaintiffs have failed to establish exclusionary conduct under a “product hopping” theory, Reckitt relies heavily upon Walgreen Co. v. AstraZeneca Pharmaceuticals L.P., 534 F.Supp.2d 146 (D.D.C.2008). In that case, AstraZeneca marketed prescription Prilosec capsules, a heartburn medication, through the expiration of its patent in October 2001. In June 2003, the FDA approved an over-the-counter version of Prilosec and granted AstraZeneca exclusivity in that market through June 2006. AstraZeneca also brought prescription Nexium, another heartburn medication, to the market during this time period, and that patent did not expire until 2014. AstraZeneca very aggressively promoted and “detailed” Nexium, while simultaneously ceasing to promote prescription Prilosec. As a result of this marketing, by the time generic prescription Prilosec entered the market, the generics were only able to capture 30% of the market, which the plaintiffs alleged was much lower than they would have captured absent AstraZ-eneca’s intervention. AstraZeneca’s conduct was alleged to be exclusionary because it used “distortion and misdirection in marketing, promoting and detailing Nexium” so as to switch the market from Prilosec, which now had generic competition, to a virtually-identical drug, Nexium, which did not. Id. at 148-49. The court determined that AstraZene-ca’s actions did not violate § 2 of the Sherman Act and granted the defendants’ motions to dismiss because marketing Nexium did not eliminate choices available to the consumer. Prescription Prilosec was never removed from the market, allowing consumers to obtain prescription Prilosec, and by extension generic Prilo-sec, if they preferred that product. Id. at 150-52. The court also found that the plaintiffs had not established an injury because “[t]he fact that a new product siphoned off some of the sales from the old product and, in turn, depressed sales of the generic substitutes for the old product” does not establish an antitrust injury, as it does not interfere with the generics’ freedom to compete. Id. at 152. Plaintiffs assert that Walgreen is factually distinguishable from the case before me, and urge that I follow the reasoning set forth in Abbott Laboratories v. Teva Pharmaceuticals USA, Inc., 432 F.Supp.2d 408 (D.Del.2006) (“TriCor”). In TriCor, the court found that the plaintiffs had stated a.claim for a § 2 antitrust violation where the defendants, the brand-name .manufacturer of TriCor, allegedly attempted to thwart generic competition through a product-hopping scheme. The plaintiffs in TriCor claimed that the defendants had engaged in the following conduct: (1) the defendants changed the formulation of TriCor from capsules to tablets in order to prevent generic substitution; (2) after the tablet formulation was approved, the defendants stopped selling TriCor capsules; (3) the defendants bought back the existing supplies of TriCor capsules from pharmacies; and (4) the defendants changed the code for TriCor capsules in the National Drug Data File (“NDDF”) to “obsolete,” which prevented pharmacies from filling TriCor prescriptions with a generic capsule formulation. Id. at 415-16. The defendants in TriCor raised a nearly identical argument as Reckitt does here: that the introduction of a new product was procompetitive per se and that improvements had been made from one formulation to another. Id. at 420. The court recognized that deference is ordinarily given to innovation and the creation of new products. However, given the unique nature of the pharmaceutical drug market and the actions taken by the defendants in removing old formulations from the market and preventing consumer choice, the court determined that the plaintiffs had set forth sufficient facts to establish exclusionary conduct and survive a motion to dismiss. Id. at 421-22. The court reasoned that the nature of the pharmaceutical drug market warranted applying the rule of reason approach identified in United States v. Microsoft Corp., 253 F.3d 34, 58 (D.C.Cir.2001), where the defendant’s procompetitive justifications are weighed against the anticompetitive results. Id. at 422. The defendants in TriCor further argued that their product-hopping could not be exclusionary because, although generic TriCor capsules could not be exchanged for a brand-name TriCor prescription, the generics were not foreclosed from marketing their own TriCor formulations. The court rejected this argument, finding that complete foreclosure from the market was not the appropriate standard. Instead, the court determined that the generics could not provide generic substitutes for the current TriCor formulation, which is alleged to be their cost-efficient means of competing in the pharmaceutical drug market. That opportunity has allegedly been prevented entirely by Defendants’ allegedly manipulative and unjustifiable formulation changes. Such a restriction on competition, if proven, is sufficient to support an antitrust claim in this case. Id. at 422. The conduct alleged in the case before me seems to fall somewhere between that alleged in Walgreen and TriCor. Unlike the facts at issue in Walgreen, Reckitt announced that it was removing Suboxone tablets from the market several months prior to generic approval, and actually did remove the tablets from the market within a few weeks of generic entry. Therefore, the freedom of consumer choice that the Walgreen court found compelling is more limited here. However, the restriction of the market’s ambit does not appear to be quite as extreme as that found in TriCor, as it is not alleged that Reckitt bought back existing Suboxone tablets or labeled the product “obsolete.” Thus, while Walgreen and TriCor are instructive, they are not dispositive of whether Plaintiffs have pleaded sufficient facts to survive Defendants’ motion on Count II. Although the issue of product-hopping is relatively novel, what is clear from the case law is that simply introducing a new product on the market, whether it is a superior product or not, does not, by itself, constitute exclusionary conduct. The key question is whether the defendant combined the introduction of a new product with some other wrongful conduct, such that the comprehensive effect is likely to stymie competition, prevent consumer choice and reduce the market’s ambit. This analysis must be undertaken with the somewhat unique characteristics of the pharmaceutical market in mind. Plaintiffs allege that the wrongful conduct included raising false safety concerns and disparaging Suboxone tablets, both of which played an important role in Reckitt’s success in switching the market from tablets to film. Reckitt counters that false disparagement of a product cannot give rise to antitrust liability under Santana Products Inc. v. Bobrick Washroom Equipment, Inc., 401 F.3d 123 (3d Cir.2005). In Santana, the United States Court of Appeals for the Third Circuit found that a company’s disparagement of another company’s product, even if the statements were untrue, was not a restraint of trade absent “coercive” measures — that is, “measures that prevented [the plaintiff] from selling its products to any willing buyer or prevented others from dealing with [the plaintiff].” Id. at 132. However, the Third Circuit has since remarked that, despite its prior holding in Santana, “in some cases, such defamation, which plainly is not competition on the merits, can give rise to antitrust liability, especially when it is combined with other anticompetitive acts.” W. Penn Allegheny Health Sys., Inc. v. UPMC, 627 F.3d 85, 109 n. 14 (3d Cir.2010) (citing LePage’s, 324 F.3d at 153, 162). Having carefully reviewed Plaintiffs’ complaint, I find that the facts presented sufficiently allege that the disparagement of Suboxone tablets took place alongside “coercive” measures. The threatened removal of the tablets from the market in conjunction with the alleged fabricated safety concerns could plausibly coerce patients and doctors to switch from tablet to film. A patient that preferred the tablets despite the safety concerns might be further persuaded to switch to the film, believing that their favored product would soon be removed from the market. Reckitt also argues that Plaintiffs’ allegations of false disparagement are insufficient because the complaints do not plead fraud with sufficient specificity to satisfy Rule 9(b) of the Federal Rules of Civil Procedure. See Lum v. Bank of America, 361 F.3d 217, 228 (3d Cir.2004) (recognizing that antitrust allegations involving fraud must comply with the pleading requirements of Rule 9(b)) (abrogation on other grounds recognized in In re Ins. Brokerage Antitrust Litig., 618 F.3d 300, 323 n. 22 (3d Cir.2010)). “Rule 9(b) requires, at a minimum, that plaintiffs support their allegations of ... fraud with all of the essential factual background that would accompany the first paragraph of any newspaper story[ — ]that is, the who, what, when, where and how of the events at issue.” U.S. ex rel. Streck v. Allergan, Inc., 894 F.Supp.2d 584, 590-91 (E.D.Pa.2012) (quoting In re Rockefeller Ctr. Props., Inc. Sec. Litig., 311 F.3d 198, 217 (3d Cir.2002)). Plaintiffs claim that in conjunction with the switch from tablet to film in 2010, Reckitt “implemented a massive fraudulent sales and marketing campaign to convert all or substantial [Suboxone] prescriptions from tablets to film.” (DP Compl. ¶ 89.) It is also alleged that Reckitt sales representatives met with physicians to promote the film formulation while simultaneously discouraging physicians from writing prescriptions for Suboxone tablets under the guise of false safety concerns— in particular, that the lack of unit dose packaging in the tablets raised the risk of pediatric exposure. (Id. at ¶¶ 89, 95.) Further, Plaintiffs claim that Reckitt announced the removal of the tablets from the market on September 25, 2012 due to fabricated safety concerns in an attempt to switch patients from the tablet to the film. (Id. at ¶¶ 89, 98-94.) Instead of actually removing the product at that time, Reckitt allegedly continued to sell tablets through March 2013, which Plaintiffs argue demonstrates the falsity of Reckitt’s stated safety concerns. (Id. at ¶ 94.) According to Plaintiffs, Reckitt’s goal in making these misrepresentations was to transfer as much of the market from tablet to film as possible prior to generic entry. (Id. at ¶ 93.) These allegations have been made with particularity in accordance with Rule 9(b), and are sufficient to “place the defendants on notice of the precise misconduct with which they are charged.” See Seville, 742 F.2d at 791. Therefore, I will consider these allegations in determining whether the complaints plausibly make out an antitrust violation. With regard to the withdrawal of Subox-one tablets from the market, Reckitt focuses on the fact that the defendants in TriCor engaged in repurchasing existing supplies held by pharmacies and changing the NDDF code to obsolete — facts which are not alleged here. Reckitt asserts that because it did not engage in this conduct, the Generics are not now, nor have they ever been, foreclosed from selling their products, which undermines Plaintiffs’ claims of exclusionary conduct. While Reckitt did not repurchase existing supplies held by pharmacies or change the NDDF code on the tablets to obsolete, the withdrawal of Suboxone tablets is alleged to have created a similar effect of reducing consumer choice. While Plaintiffs acknowledge that the Generics have not been completely foreclosed from the market, neither were the generics in TriCor. As noted previously, complete foreclosure is not the standard articulated by the Third Circuit for establishing anticom-petitive conduct. Rather, “[t]he test is not total foreclosure, but whether the challenged practices bar a substantial number of rivals or severely restrict the market’s ambit.” Dentsply, 399 F.3d at 191. As recognized in TriCor, “[competitors need not be barred ‘from all means of distribution,’ if they are barred ‘from the cost-efficient ones.’ ” TriCor, 432 F.Supp.2d at 423 (quoting Microsoft, 253 F.3d at 64). Plaintiffs have plausibly alleged that various market forces unique to the pharmaceutical industry make generic substitution the cost-efficient means of competing for companies selling generic pharmaceuticals. For example, Plaintiffs' assert that a disconnect exists between the person paying for the prescription and the person selecting the appropriate treatment. Due to this disconnect, the ordinary market forces that would allow consumers to consider price when selecting a product are derailed. The patient also cannot simply request to receive a generic from his or her pharmacist because the film and the generic tablets are not AB-rated and thus may not be substituted. For all of these reasons, as it relates to their “product-hopping” allegations, I find that Plaintiffs have plausibly pleaded exclusionary conduct, as required for an antitrust claim. 2. Does the Complaint Sufficiently Plead an Injury to Competition? Having determined that Plaintiffs have sufficiently alleged exclusionary conduct as it relates to the “product-hopping” scheme, I now turn to whether an antitrust injury has been properly pleaded. Reckitt argues that Plaintiffs have failed to establish an antitrust injury on Count II because the introduction of Suboxone film in and of itself is not alleged to have delayed Generic entry into the marketplace. Reckitt urges that the only injury that could have been caused by the film’s introduction stems from an increase in competition. Lost profits attributable to increased competition is not the type of injury the antitrust laws were designed to redress. See Brunswick Corp. v. Pueblo Bowl-O-Mat, Inc., 429 U.S. 477, 488-89, 97 S.Ct. 690, 50 L.Ed.2d 701 (1977). The antitrust laws “were enacted for ‘the protection of competition not competitors.’ ” Id. at 488, 97 S.Ct. 690 (quoting Brown Shoe Co. v. United States, 370 U.S. 294, 320, 82 S.Ct. 1502, 8 L.Ed.2d 510 (1962)). “[W]hen an alleged antitrust conspiracy involves multiple acts, [t]he character and effect of [that] conspiracy are not to be judged by dismembering it and viewing its separate parts, but only by looking at it as a whole.” SmithKline Beecham Corp. v. Apotex Corp., 383 F.Supp.2d 686, 699, 702 (E.D.Pa.2004) (quoting Cont’l Ore Co. v. Union Carbide & Carbon Corp., 370 U.S. 690, 699, 82 S.Ct. 1404, 8 L.Ed.2d 777 (1962)) (quotation marks omitted). “[T]he existence of antitrust injury is not typically, resolved through motions to dismiss,” although courts can and do decide these issues at the 12(b)(6) stage. Schuylkill Energy Res., Inc. v. Pa. Power & Light Co., 113 F.3d 405, 416-19 (3d Cir.1997) (citing Brader v. Allegheny Gen. Hosp., 64 F.3d 869, 876 (3d Cir.1995)). Plaintiffs allege that by'wrongfully suppressing generic competition on the market, they were forced to pay more for Suboxone products than they otherwise would have paid. “When a monopolist’s actions are designed to prevent one or more new or potential competitors from gaining a foothold in the market by exclusionary, i.e. predatory, conduct, its success in that goal is not only injurious to the potential competitor but also to competition in general.” LePage’s, 324 F.3d at 159; see also Dentsply, 399 F.3d at 191. Although Count II of the Direct Purchasers’ complaint relates to Reckitt’s introduction of Suboxone film, and generally the introduction of new products does not create antitrust injury, I must still consider Plaintiffs’ allegations of Reckitt’s activity as a whole, which includes the withdrawal of Suboxone tablets, the alleged fraudulent marketing campaign and tactics designed to delay ANDA approval (discussed infra). If the anticompetitive effect of this conduct is proven, and it resulted in purchasers paying inflated prices, Plaintiffs could establish harm to competition itself. See Tunis Bros. Co. v. Ford Motor Co., 952 F.2d 715, 728 (3d Cir.1991) (“An antitrust plaintiff must prove that challenged conduct affected the prices, quantity or quality of goods or services”) (quotation marks omitted). Therefore, I find that Plaintiffs have pleaded sufficient facts to establish antitrust injury. Defendants further allege that the Direct Purchasers do not have standing because there is a more direct victim of Reekitt’s conduct — the Generic manufacturers. Section 4 of the Clayton Act, which allows treble damages for violation of the antitrust laws, states as follows: “any person who shall be injured in his business or property by reason of anything forbidden in the antitrust laws may sue therefor in any district court of the United States ... and shall recover threefold the damages by him sustained.” 15 U.S.C. § 15. The Direct Purchasers who are overcharged as a result of an antitrust violator’s actions are generally considered to have antitrust standing. See Illinois Brick Co. v. Illinois, 431 U.S. 720, 729, 97 S.Ct. 2061, 52 L.Ed.2d 707 (1977) (“the overcharged direct purchaser, and not others in the chain of manufacture or distribution, is the party ‘injured in his business or property’”). Therefore, I do not find Reckitt’s standing argument convincing. In conclusion, I find that the Direct Purchasers’ claim under Count II for introduction of the Suboxone film in the context of an alleged product-hopping scheme should survive the motion to dismiss stage. C. Count III — Unlawful Maintenance of Monopoly Power by Intentionally Delaying the SSRS Process and Violating 21 U.S.C. § 355-l(f)(8) Reckitt asserts that Count III of the Direct Purchaser’s complaint should be dismissed because the SSRS process, where the parties tried to work together to establish the safe use of the drug, was simply a course of dealing and the antitrust laws do not obligate Reckitt to interact with its competitors on terms they find' favorable. Reckitt garners support from a line of Supreme Court cases on the “duty to deal.” In Verizon Communications Inc. v. Law Offices of Curtis V. Trinko, LLP, 540 U.S. 398, 124 S.Ct. 872, 157 L.Ed.2d 823 (2004), the Supreme Court considered whether a complaint alleging that Verizon had. breached its duty under the Telecommunications Act of 1996 to facilitate market entry by competitors stated a claim for violation of § 2 of the Sherman Act. The Telecommunications Act of 1996 required Verizon, and other incumbent local telephone companies, to facilitate competitors’ market entry by requiring the incumbent to share • its network with competitors. Verizon was also obligated to provide access to its operations support systems, which ensured quality of service. Verizon was accused of intentionally failing to -fill operations support orders in violation of the Act and was investigated by the FCC for its conduct. Customers of Verizon’s competitors filed suit for antitrust violation, alleging that Verizon had engaged in an anticompetitive scheme to discourage customers from becoming or remaining customers of competing companies. Id. at 402-04, 124 S.Ct. 872. The Court held that “as a general matter, the Sherman Act ‘does not restrict the long recognized right of [a] trader or manufacturer engaging in an entirely private business, freely to exercise his own independent discretion as to the parties with whom he will deal.’ ” Id. at 408, 124 S.Ct. 872 (quoting United States v. Colgate & Co., 250 U.S. 300, 307, 39 S.Ct. 465, 63 L.Ed. 992 (1919)). The Court concluded that the antitrust laws did not create a duty to deal in that instance, as they provided little additional benefit to the regulations already in place. The Court noted “[w]here such a [regulatory] structure exists, the additional benefit to competition provided by antitrust enforcement will tend to be small, and it will be less plausible that the antitrust laws contemplate such additional scrutiny.” Id. at 411-12, 124 S.Ct. 872. The Supreme Court reaffirmed these principles in Pacific Bell Telephone Co. v. Linkline Communications, Inc., 555 U.S. 438, 129 S.Ct. 1109, 172 L.Ed.2d 836 (2009). There, the FCC required AT & T to sell transmission service to independent DSL providers for the purposes of increasing competition. Although it made its service available, AT & T was accused of “price squeezing” its competitors — that is, providing access to its DSL framework to competitors on the wholesale market at a high price, but selling its DSL services to customers on the retail market at a low price. The plaintiffs alleged that AT & T’s competitors were driven out of the market because the high wholesale costs prevented them from matching AT & T’s low retail prices. Linkline, 555 U.S. at 442-43, 129 S.Ct. 1109. The Court, relying on Trinko, held that the high wholesale prices to competitors did not violate the antitrust laws in the absence of a “duty to deal.” The Court further reasoned that the plaintiffs could not establish an antitrust injury based on AT & T charging customers at low rates unless the plaintiffs demonstrated predatory pricing — that is, pricing below costs where there is a dangerous probability that the losses can be recouped. Id. at 450-51,129 S.Ct. 1109. Trinko and Linkline instruct that the antitrust laws do not create a duty for competitors to work together. Statutes and regulations requiring cooperation between rivals do not alter this analysis; in fact, regulation indicates that antitrust scrutiny is not necessary or prudent. The Court noted that although the right for a monopolist to refuse to deal with its competitors is not unqualified, it has “been very cautious in recognizing such exceptions, because of the uncertain virtue of forced sharing and the difficulty of identifying and remedying anticompetitive conduct by a single firm.” Trinko, 540 U.S. at 408,124 S.Ct. 872. The main exception to the line of cases holding that competitors do not have a duty to deal is Aspen Skiing Co. v. Aspen Highlands Skiing Corp., 472 U.S. 585, 105 S.Ct. 2847, 86 L.Ed.2d 467 (1985). There, the Court considered a course of dealing between two companies that owned ski resorts in Aspen. Beginning in 1962, the companies worked together to sell skiers an interchangeable ticket that could be used on any of the four mountains in Aspen. Id. at 587-89, 105 S.Ct. 2847. For over fifteen years, Aspen Skiing Co. and Aspen Highlands coordinated to issue passes that covered both companies’ mountains and divided the profits according to the percentage of skiers that visited a particular mountain. Id. at 591, 105 S.Ct. 2847. However, in 1978, Aspen Skiing Co. decided to discontinue the 4-area ticket unless Aspen Highlands would accept a 12.5% fixed percentage of the revenue, which was lower than the actual usage of its mountain. When Highlands refused, Aspen Skiing Co. began selling a pass covering only its three mountains. When Highlands attempted to purchase Aspen Skiing’s lift tickets to create a multi-pass on its own, Aspen Skiing refused, even at retail price. Id. at 592-94, 105 S.Ct. 2847. Highlands brought an antitrust claim under § 2, arguing that Aspen Skiing had monopolized the market for downhill skiing in Aspen. The Court ultimately held that the right to refuse to deal was not unqualified, and that a reasonable jury could find that Aspen Skiing’s conduct was exclusionary. In reaching this conclusion, the Court significantly relied upon the prior cooperation between the two competitors that spanned many years. The Court noted that there was significant consumer demand for the four-mountain pass and many consumers felt that they could not go to the mountain of their choice once that pass had been eliminated. The Court determined that by prohibiting Highlands’ use of its lift tickets, even at market price, Aspen Skiing’s sole motivation was to harm Highlands. Id. at 601, 605-09,105 S.Ct. 2847. Here, throughout the SSRS process, the FDA directed the parties to work together in good faith to develop a REMS program that would ultimately lead to ANDA approval for the Generics. The parties engaged in negotiations, and Reckitt is alleged to have taken unreasonable positions and utilized delay tactics to keep Generics off of the market for as long as possible. This SSRS process, in which competitors were required to work together, should be analyzed in light of the precedent outlined above. Plaintiffs rely heavily upon 21 U.S.C. § 355 — 1(f)(8), which requires the parties to work together in good faith and not use the SSRS process to block or delay ANDA approval. However, Linkline and Trin-ko undermine Plaintiffs’ position, as the Supreme' Court has unequivocally stated that statutes and regulations requiring cooperation between competitors do not create an antitrust duty to deal. In fact, these cases found that the regulatory structure requiring cooperation actually diminishes the need for antitrust scrutiny. Aspen Skiing, the only Supreme Court case recognizing a failure to deal as anti-competitive, does not apply here because there is no long-standing, preexisting course of dealing between Reckitt and the Generics. Finally, Plaintiffs note that the only two cases from this circuit alleging antitrust violations for failure to provide information during the REMS process survived the motion to dismiss stage. See Lannett Co., Inc. v. Celgene Corp., Dkt. No. 08-cv-3920, Doc. No. 42 (E.D.Pa. Mar. 30, 2011) (Savage, J.) (denying motion to dismiss without comment); Actelion Pharm. Ltd. v. Apotex Inc., 12-cv-5743, Doc. No. 90 (D.N.J. Oct 21, 2013) (Hillman, J.) (denying motion for judgment on the pleadings “for reasons stated during oral argument”). While this is true, Lannett and Actelion are distinguishable because the elements to assure safe use in those cases prevented the generics from obtaining the brand-name pharmaceutical to conduct bioequivalency testing during the REMS process. Therefore, the generics were allegedly unable to file an ANDA as a result of the defendants’ actions. Here, the Generics were able to obtain Suboxone and conduct bioe-quivalency testing, as their ANDAs were pending before the SSRS process even began. The Generics were also capable of submitting an SSRS without Reckitt’s involvement, and ultimately did just that. It would have been easier to have Reckitt provide its REMS to its competitors with no strings attached, and participation on Reckitt’s part would have allowed the process to move more quickly. However, a monopolist “certainly has no duty to deal under terms and conditions that the rivals find commercially advantageous.” Link-line, 555 U.S. at 450,129 S.Ct. 1109. The antitrust laws do not impose a duty on Reckitt to aid the Generics in obtaining expeditious approval of an ANDA. While other courts have indicated that antitrust liability may attach where the SSRS process is manipulated to completely preclude a generic from filing an ANDA, that is not the situation presently before me. To the extent that § 355 — 1(f)(8) prohibits name-brand drug manufacturers from manipulating the process to cause delay, this statute provides for increased FDA oversight and diminishes the need for antitrust scrutiny. Accordingly, I will grant Reekitt’s motion as to Count III of the Direct Purchasers’ complaint. D. Counts IV & V — Unlawful Maintenance of Monopoly Power by Filing a Sham Citizen Petition and Unlawful Maintenance of Monopoly Power by Fraudulently Delayiny the Fil-iny of the Citizen Petition Reckitt next argues that Counts IV and V of the Direct Purchasers’ complaint must be dismissed for two reasons: (1) Plaintiffs have failed to adequately plead that the Citizen Petition was a sham, such that it would be subject to antitrust scrutiny; and (2) even if the Citizen Petition was a sham, a statute forbid the FDA from delaying ANDA approval while the Petition was decided, and therefore, no injury could have resulted. I address these arguments in turn. 1. Have Plaintiffs Plausibly Pleaded that the Citizen Petition was a Sham? “Those who petition government for redress are generally immune from antitrust liability.” Prof'l Real Estate Investors, Inc. v. Columbia Pictures Indus., Inc., 508 U.S. 49, 56, 113 S.Ct. 1920, 123 L.Ed.2d 611 (1993). However, immunity is not extended to “sham” activities — that is, activity (1) that is “objectively baseless in the sense that no reasonable litigant could realistically expect success on the merits”; and (2) which “conceals ‘an attempt to interfere directly with the business relationships of a competitor,’ through the ‘use [of] the governmental process — as opposed to the outcome of that process — as an anti-competitive weapon.’ ” Id. at 60-61, 113 S.Ct. 1920 (quoting E. R.R. Presidents Conference v. Noerr Motor Freight, Inc., 365 U.S. 127, 144, 81 S.Ct. 523, 5 L.Ed.2d 464 (1961); City of Columbia v. Omni Outdoor Adver., Inc., 499 U.S., 365, 380, 111 S.Ct. 1344, 113 L.Ed.2d 382 (1991)) (emphasis in original). 21 U.S.C. § 355(q)(l)(E) provides that “[i]f the Secretary determines that a [Citizen] [P]etition ... was submitted with the primary purpose of delaying the approval of an application and the petition does not on its face raise valid scientific or regulatory issues, the Secretary may deny the petition at any point based on such determination.” When Reckitt’s Citizen Petition was initially submitted, several Generics requested that the FDA deny it as frivolous and intended for delay under this Section, but the FDA declined to do so. (DP Compl., Exs. E, G.) Reckitt urges that I find as a matter of law that the Citizen Petition was not a sham based upon the Petition itself and the FDA’s response thereto. Whether petitioning activity is a sham is generally a question for the jury. In re Flonase Antitrust Litig., 795 F.Supp.2d 300, 310 (E.D.Pa.2011). However, “a court may decide probable cause as a matter of law” where “there is no dispute over the predicate facts of the underlying ... proceeding.” Prof'l Real Estate Investors, Inc., 508 U.S. at 63, 113 S.Ct. 1920. Reckitt argues that the Petition was not a sham because (1) the FDA took the full 150-day period for review and denied requests to summarily deny the petition; (2) the FDA granted partial relief on Reckitt’s requests; (3) a reasonable litigant would not have known that the FDA would require Reckitt to provide stringent proof of causation; and (4) the regulations that prohibited the FDA from granting Reckitt’s requested relief were being considered for amendment at the time the Petition was filed. Plaintiffs respond that questions of fact preclude the Court from determining whether the Petition was objectively baseless at this early stage. While the FDA did not dismiss Reckitt’s Citizen Petition outright as baseless and having been submitted purely for the purpose of delay, §'355(q)(l)(E) does not require such an action. It states that the FDA may deny a petition at any point based on a finding of frivolousness, but it does not require summary denial. Thus, I cannot assume that the Petition must have merit' simply because the FDA did not exercise its right to dismiss it outright. Moreover, upon denying the Citizen Petition, the FDA referred Reckitt to the FTC, and noted that the timing of Reck-itt’s activities with announcing the withdrawal of Suboxone tablets and the filing of the Citizen Petition “given its close alignment with the period in which generic competition for [that] product was expected to begin, cannot be ignored.” (DP Compl., Ex. G, pp. 15-16.) The FDA acknowledged in its ruling that it had no authority to grant much of Reckitt’s requested relief. (See supra p. 676.) The FDA cannot require ANDA filers to mimic non-approved labeling and REMS materials in order to obtain approval, due to 21 U.S.C. § 355(j)(4)(G) and 21 C.F.R. § 314.127(a)(7). (See DP Compl., Ex. G., p. 12 (“The FD & C Act requires that labeling for an ANDA be the same as the labeling ‘approved for the listed drug’ ”).) Additionally, despite Reckitt’s request that the FDA investigate why Suboxone tablets had been withdrawn from the market, Reckitt was continuing to sell the product at that time. (Id. at pp. 14-15.) Finally, the FDA determined that Reckitt did not provide evidence that the measures it sought to impose caused any decline in accidental pediatric exposures. Indeed, the study Reckitt submitted in support of its Petition “acknowledged that the impact of education interventions and packaging on the decline in pediatric exposure was not evaluated, and that definitive conclusions about these measures could not be reached.” (Id. at p. 9.) In short, the FDA denied all of Reckitt’s requested relief. Much of the relief sought was not even available to the FDA to grant, and Reckitt sought an investigation of its own reasons for withdrawing Suboxone tablets at a time when the tablets remained on the market. As such, Plaintiffs have plausibly pleaded that the Petition was objectively baseless in that no reasonable litigant could have realistically expected success on the merits. I also find that Plaintiffs have adequately alleged that Reckitt had the subjective intent to interfere with the business of a competitor through the use of the petitioning process. 2. Have Plaintiffs Established an Antitrust Injury Regarding the Citizen Petition? I next consider Reckitt’s argument that the filing of a Citizen Petition did not cause antitrust injury. 21 U.S.C. § 355(q)(l)(A) states that the Secretary shall not delay approval of an NDA or ANDA because of a Citizen Petition unless “the Secretary determines, upon reviewing the petition, that a delay is necessary to protect the public health” and that “[Consideration of the petition shall be separate and apart from review and approval of any application.” Plaintiffs have alleged that despite this statutory framework, delays still occur and did occur in this instance. Reckitt responds that Plaintiffs’ failure to articulate that the FDA violated 21 U.