Antitrust Law Daily Wrap Up, ANTITRUST—D.N.J.: Court trims Copaxone monopolization case against Teva, (Apr 14, 2026)

By Martin A. Steinberg, J.D.

Teva allegedly used PBM deals, a DAW campaign, a shift to 40 mg Copaxone, and copay assistance to block generic competition and preserve its monopoly.

The New Jersey federal district court adopted a special master’s report and recommendation and granted Teva’s motion to dismiss in part in the antitrust litigation over multiple-sclerosis drug Copaxone. The court agreed that plaintiffs plausibly alleged monopoly power and allowed claims based on Teva’s alleged exclusionary agreements with pharmacy benefit managers (PBMs) and a “Dispense as Written” (DAW) campaign to proceed. But it dismissed theories based on Teva’s earlier shift from 20 mg to 40 mg Copaxone and its copay-assistance program, finding the market-shift allegations fell outside the Sherman Act limitations period and that the copay-assistance allegations reflected lawful price competition rather than anticompetitive conduct. The court also agreed that those two categories did not plausibly augment the surviving exclusionary-conduct theories as part of an overall monopolization scheme (In re Copaxone Antitrust Litigation, No. 2:22-cv-01232-JXN-JSA (D.N.J. Apr. 13, 2026)).

This is one of two pharmaceutical antitrust cases involving Copaxone, a drug used to treat multiple sclerosis. Plaintiffs retailers Walgreen Co., the Kroger Co., Albertsons Companies, Inc., and H-E-B, L.P. filed suit against defendants Teva Pharmaceuticals, Ltd., Teva Pharmaceuticals USA, Inc., Teva Neuroscience, Inc., and Teva Sales & Marketing, Inc. The other case is Mylan Pharms. v. Teva Pharms. Indus. Ltd., No. 21-13087 (D.N.J.).

Background. Teva manufactures Copaxone, an injectable multiple-sclerosis drug, first approved by the FDA in 1996 as a 20 mg vial and later as a pre-filled 20 mg syringe in 2002, with the 20 mg patents expiring in May 2014. Sandoz filed an Abbreviated New Drug Application (ANDA) for a generic 20 mg formulation of Copaxone in 2007, and the FDA approved the product in April 2015. Teva then developed a 40 mg pre-filled syringe version, approved in January 2014 for three-times-weekly use, with exclusivity expiring in January 2017. Mylan filed ANDAs for both 20 mg and 40 mg generic Copaxone, and the FDA approved both on October 3, 2017, with launch the next day.

PBMs are intermediaries between insurers and consumers that negotiate drug prices with manufacturers, set pharmacy reimbursements, and often own specialty pharmacies. They create formularies that determine which drugs a health plan will cover, so exclusion from a formulary can force patients to pay out of pocket. The complaint alleges that the PBM market is highly concentrated and that PBMs’ formulary decisions can be influenced by manufacturers’ rebate strategies, thereby giving PBMs substantial control over which drugs patients receive and at what cost.

Alleged scheme. The complaint alleged that Teva used a scheme to protect Copaxone from generic competition by entering into exclusionary agreements with PBMs to keep generic Copaxone off formularies and rewarded specialty pharmacies for dispensing the brand drug, ran a DAW campaign in which sales representatives allegedly made false statements to persuade doctors to prescribe brand Copaxone, shifted the market from 20 mg to 40 mg Copaxone to blunt generic substitution, and funded copay-assistance programs through charities to keep patients on the brand product. According to the complaint, those tactics succeeded by allowing Teva to retain a large share of the Copaxone market even after generics became available at much lower prices.

Procedural history. Four drug wholesalers (“original plaintiffs”) filed a putative class action lawsuit against Teva in 2022. The class included any company that bought Copaxone directly from Teva. The original wholesaler plaintiffs alleged that Teva’s PBM agreements, DAW campaign, market shift, and copay-assistance program formed a scheme to monopolize the Copaxone market. Also, they asserted a RICO claim based on the allegations of copay assistance. After Teva moved to dismiss, a special master recommended letting the PBM and DAW theories proceed, while dismissing the market-shift theory as untimely and the copay-assistance theory as nonexclusionary and insufficiently connected to the surviving conduct. The special master also recommended dismissal of the RICO claim. The wholesalers chose to amend rather than object, adding new allegations of copay assistance and new plaintiffs.

At the same time, the retailers filed a separate Sherman Act case in Vermont that was later transferred to New Jersey and consolidated for pretrial purposes. Under a stipulation, the retailers agreed to be bound by the report regarding the overall scheme claim but preserved objections to the recommendations on market shift and copay assistance. Their objections argued that the special master misapplied the statute of limitations, wrongly required that those elements cause harm within the limitations period, and erred in concluding that they were not independently unlawful.

Objection One: the statute of limitations. The court first addressed the retailers’ statute-of-limitations objection and rejected it. The court stated that the retailers misread the special master’s analysis because the report did not treat the copay-assistance allegations as untimely; instead, it considered when that conduct occurred in evaluating their relevance. As to the market shift, however, the court agreed that it, and any resulting harm, fell outside the four-year Sherman Act limitations period. Because the alleged switch from 20 mg to 40 mg Copaxone occurred in 2014 and 2015, and generics for both strengths were available throughout the 2018 to 2022 limitations period, the complaint did not plausibly allege that the market shift caused actionable harm within the relevant period. The court therefore concluded that the special master correctly found the market-shift theory time-barred.

Objection Two: overall scheme liability. The court rejected the retailers’ argument that the special master improperly dismissed the market-shift and copay-assistance allegations as part of the overall monopolization scheme. The court explained that, under Third Circuit law, lawful conduct may be considered as part of an overall Section 2 scheme only if it plausibly contributes to the exclusionary effect of independently anticompetitive conduct. Applying that framework, the court agreed with the special master that Teva’s pre-generic conduct—the market shift and most of the copay assistance—was separate in time and substance from the later PBM agreements and DAW campaign, which were the adequately pleaded exclusionary acts. Because the complaint did not plausibly allege that the earlier conduct augmented, reinforced, or otherwise synergized with the later conduct aimed at suppressing generic competition, the court overruled the retailers’ second objection.

Objection Three: unlawful conduct. The court next addressed whether the market-shift and copay-assistance allegations could independently support Section 2 liability. It first held that the market-shift theory cannot do so because, whatever its alleged anticompetitive character, both the conduct and its attendant harms occurred outside the Sherman Act limitations period. Regarding copay assistance, the court agreed with the special master that those allegations do not describe anticompetitive conduct. The court reasoned that making brand Copaxone cheaper through copay assistance reflects ordinary price competition on the merits rather than exclusionary conduct. It rejected the retailers’ broader theory that any action that induces patients to remain on a brand drug in the face of generic competition is automatically anticompetitive. Because the complaint did not plausibly allege that the copay-assistance program harmed competition rather than lowered prices, the court concluded that the copay-assistance allegations also could not independently sustain a monopolization claim.

The Case is No. 2:22-cv-01232-JXN-JSA.

Judge: Neals, J.

Attorneys: Joseph H. Meltzer (Kessler Topaz Meltzer & Check, LLP) for FWK Holdings, LLC, Healthcare Services, Inc. d/b/a Kinney Drugs, Inc., Meijer, Inc. and Meijer Distribution, Inc. Stephanie Egner Smith (Roberts Law Firm US, PC) for KPH Healthcare Services, Inc. a/k/a Kinney Drugs, Inc. Liza M. Walsh (Walsh Pizzi O'Reilly Falanga LLP) for Teva Pharmaceuticals Industries, Ltd., Teva Pharmaceuticals USA, Inc., Teva Neuroscience, Inc., and Teva Sales & Marketing, Inc.

Companies: FWK Holdings, LLC; Healthcare Services, Inc. d/b/a Kinney Drugs, Inc.; Meijer, Inc.; Meijer Distribution, Inc.; KPH Healthcare Services, Inc. a/k/a Kinney Drugs, Inc.; Teva Pharmaceuticals Industries, Ltd.; Teva Pharmaceuticals USA, Inc.; Teva Neuroscience, Inc.; Teva Sales & Marketing, Inc.

Cases: Antitrust NewJerseyNews