First Jury Verdict For Private Plaintiffs In Pay-For-Delay Litigation Results In $885 Million Award

On May 18, 2026, a jury in the U.S. District Court for the District of Massachusetts, in a case before Judge Myong J. Joun, returned a verdict finding a global pharmaceutical company liable for approximately $885 million in damages for allegedly delaying a generic version of the drug Amitiza (lubiprostone) through an anticompetitive pay-for-delay settlement agreement with Par Pharmaceutical, Inc. (“Par”, together with a global pharmaceutical company, the “Defendants”) and the global pharmaceutical company’s collaboration partner, Sucampo Pharmaceuticals, Inc.  In re Amitiza Antitrust Litigation, No. 21-11057-MJJ (D. Mass. May 18, 2026).  The verdict marks the first time a jury has found a company liable in class-action antitrust litigation challenging a pay-for-delay agreement. 

Amitiza is a prescription drug approved by the FDA in 2006 for the treatment of chronic constipation, irritable bowel syndrome with constipation, and opioid-induced constipation. According to the complaint, Par filed an abbreviated new drug application with the FDA in February 2010 seeking approval to sell a generic version of Amitiza; the FDA accepted the application for review in August 2012.  In response, defendant sued Par for patent infringement in February 2013, with the lawsuit being settled in late 2014.  Under the settlement, Par allegedly agreed to (a) delay selling a generic version of Amitiza until January 1, 2021, and (b) pay a 50% royalty to defendant on its sales—far less than the industry standard for authorized generic royalty rates of 90%—which effectively functioned as a reverse payment to Par in exchange for delayed entry.  Because Par was the first generic manufacturer to file an application with the FDA and thus was entitled to a 180-day exclusivity period, no other generic could enter the market until Par did; thus, by delaying Par’s entry, the settlement effectively delayed all generic competition for Amitiza. 

In 2021, a certified class of direct purchasers, a class of third-party payors (insurers), and individual retailers filed suit, alleging that the settlement constituted an anticompetitive pay-for-delay agreement that delayed generic entry and caused purchasers to overpay for the drug in violation of Sections 1 and 2 of the Sherman Act. The complaint alleged that Par would have begun selling generic Amitiza no later than January 2016, five years prior to the actual launch, if not for the settlement. 

Under the framework established in FTC v. Actavis, Inc., 570 U.S. 136 (2013), pay-for-delay agreements are not presumptively lawful merely because they fall within the scope of a patent; they are instead subject to antitrust scrutiny under the rule of reason.  Plaintiffs argued that the reverse payment to the manufacturer was large and unjustified, and that absent the settlement, generic competition would have entered the market significantly earlier, driving down prices. In response, defendant countered that the settlement was a lawful resolution of patent litigation, that any delay in the launch of the generic was due to the fact that the FDA had not yet granted the manufacturer approval to commercialize its product, and that without the settlement generic Amitiza would still not be available to patients (as the patent runs through October 2027, absent further litigation). 

After a four-week trial that began on April 13, 2026, the jury reached its verdict on the second day of deliberations, awarding plaintiffs $884,943,990 in damages.  The jury found that defendant possessed substantial market power within the relevant market and that, absent the unlawful agreement, the generic would have entered the market in April 2018.  Additionally, the jury found the settlement agreement contained a large and unjustified reverse payment.  The damages break down as follows: $474 million to a class of direct purchasers, $63 million to a class of insurers who paid claims for the drug, and $346 million to a group of individual retailers (including CVS, Walgreens, Albertsons, and Kroger).  The damages awarded to the direct purchasers and individual retailers are subject to automatic trebling upon entry of judgment, meaning total exposure could rise to several billion dollars.  Damages remain subject to further proceedings, and the jury's verdict is not enforceable until the Court enters judgment at a later date.  Defendant has stated that it will appeal the verdict.