Health Law Daily Wrap Up, ANTITRUST—3d Cir.: Appellate court will not reopen Lipitor litigation dismissal, (Sep 16, 2026)

By Jody Coultas, J.D.

The Lipitor purchasers failed to show the FDA would have approved generic Lipitor earlier absent challenged settlement.

The U.S. Court of Appeals for the Third Circuit will not review its previous holding dismissing an antitrust suit filed by direct purchasers and retailers alleging that Pfizer and Ranbaxy entered into a reverse settlement agreement that unlawfully delayed entry of generic Lipitor into the market. Under the settlement, Ranbaxy agreed to cease contesting a Pfizer Lipitor patent set to expire in June 2011, while Pfizer granted Ranbaxy a license to launch generic Lipitor on November 30, 2011, assuming FDA approval was obtained. The federal district court in New Jersey concluded that purchasers, payors, and retailers failed to establish antitrust standing. The Third Circuit affirmed, holding that the plaintiffs did not present sufficient evidence that the FDA would have approved Ranbaxy's generic Lipitor application before November 30, 2011, absent the challenged settlement agreement with Pfizer. Because the named plaintiffs lacked viable claims, the court also concluded they could not serve as class representatives. CVS Pharmacy, Inc., Walgreen Co., Meijer, Inc., and Giant Eagle, Inc. petitioned the Third Circuit for a rehearing, but the court declined to reassess the case (In re Lipitor Antitrust Litigation, MDL No. 2332 (3d Cir. Sep. 8, 2026)).

Background. Ranbaxy had become the first manufacturer in 2002 to file an abbreviated new drug application, or ANDA, for generic Lipitor with a Paragraph IV certification. That filing entitled Ranbaxy to an 180-day exclusivity period as the first filer, provided the application was substantially complete. Pfizer later prevailed in patent litigation against Ranbaxy, and additional patent disputes between the companies followed. The companies eventually settled patent litigation involving Lipitor and another drug, Accupril. Under the settlement, Ranbaxy agreed to cease contesting a Pfizer Lipitor patent set to expire in June 2011, while Pfizer granted Ranbaxy a license to launch generic Lipitor on November 30, 2011, assuming FDA approval was obtained.

Before and after the settlement, Ranbaxy faced regulatory difficulties with the FDA. In 2009, the FDA invoked its Application Integrity Policy and suspended review of affected applications, including the generic Lipitor ANDA. The FDA later granted Ranbaxy an exception from the policy in May 2011 to allow expedited review of the Lipitor application. During the review process, Ranbaxy submitted multiple amendments to its application and repeatedly sought approval before the planned launch date. On November 29, 2011, the FDA informed Ranbaxy that it could not predict when a remaining component of its review would be completed and could not guarantee approval the following day. The FDA ultimately approved the application on November 30, 2011, and Ranbaxy launched generic Lipitor that same day.

Procedural history. In June 2024, the New Jersey district court granted summary judgment to Ranbaxy, concluding that the plaintiffs failed to create a genuine issue of material fact that the FDA would have approved Ranbaxy's ANDA earlier than it did. The district court denied certification of proposed end-payor classes for failure to demonstrate a reliable and administratively feasible method for identifying class members and exclusions. Further, the court found that the proposed approach raised concerns about identifying and excluding entities such as government payors, fully insured health plans, third-party administrators, and administrative services organizations. It also concluded that the process appeared likely to require burdensome individualized inquiries and "mini-trials."

The Third Circuit affirmed the lower court decision. It acknowledged that the FDA was motivated to bring a generic Lipitor product to market as quickly as possible and that the agency undertook expedited review. However, the court found that the record showed the FDA repeatedly stated that it could not guarantee approval by November 30, 2011, even while actively working toward that goal. The court noted that expedited review still took approximately six and one-half months and that, even on the day before approval, the FDA warned that approval the next day could not be guaranteed. According to the court, the record demonstrated only that earlier approval was possible, not that it was more likely than not.

The court further observed that no evidence showed the FDA would have revoked Ranbaxy's first-filer exclusivity or approved another manufacturer's generic product before November 30, 2011. Other manufacturers also received expedited review, but none obtained approval before Ranbaxy. Because the plaintiffs failed to present "specific or concrete evidence" that the FDA would have granted approval earlier in the absence of the settlement, the court held that they could not establish antitrust standing, making summary judgment for Ranbaxy appropriate.

Further, the court affirmed denial of the direct purchaser and end payor plaintiffs' class certification motions. It explained that once summary judgment eliminated the named plaintiffs' claims against Ranbaxy, those plaintiffs could no longer adequately represent a class. Citing Rule 23's adequacy requirement, the court stated that plaintiffs without viable claims cannot serve as class representatives. The court therefore concluded that denial of class certification was proper, while expressly declining to address other aspects of the district court's class-certification analysis.

Rehearing. The Third Circuit denied a petition for rehearing filed by CVS Pharmacy, Walgreen, Meijer, and Giant Eagle. The motion was submitted to the judges who participated in the decision and to all the other available circuit judges. None of the judges who concurred in the decision asked for rehearing, and a majority of the judges of the circuit in regular service did not vote for rehearing.

The cases are Nos. 24-2184, 24-2185, 24-2189, 24-2194, 24-2202, 24-2203, 24-2256 & 24-2257.

Attorneys: John P. Bjork (Sperling Kenny Nachwalter) for Meijer Inc. Devora W. Allon (Kirkland & Ellis) for Ranbaxy Inc.

Companies: Meijer Inc; Ranbaxy Inc.; CVS Pharmacy, Inc.; Walgreen Co.; Giant Eagle, Inc.

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