Alkermes sued over alleged scheme to block generic Vivitrol
03/10/2025 15:21
By Mike Scarcella Oct 3 (Reuters) - A drug wholesaler has sued Alkermes ALKS.O for allegedly maintaining an illegal monopoly over the opioid and alcohol dependence drug Vivitrol, causing buyers to pay hundreds of millions of dollars in overcharges. In a proposed class action filed on Thursday in the federal court in Boston, Value Drug Company said Alkermes fraudulently obtained a key patent for Vivitrol and used it to block cheaper generic competition for years, in violation of federal antitrust law. The lawsuit claimed Alkermes improperly listed the patent in the U.S. Food and Drug Administration’s Orange Book, a catalog of patents covering FDA-approved drugs. Orange Book listings can trigger automatic delays in generic approvals. Alkermes in a statement said it would review the lawsuit with its legal team. Lawyers for Pennsylvania-based Value Drug did not immediately respond to requests for comment. Value Drug is seeking class-action status for an unspecified number of purchasers of Vivitrol. Alkermes is based in Ireland and has U.S. headquarters in Massachusetts. The FDA approved Vivitrol, the brand name for injectable naltrexone, in 2006. Alkermes’ monopoly over the drug is protected by a single patent that issued in 2011 and has a 2029 expiration, according to the lawsuit. A generic version should have been available in the United States by mid-2020, the lawsuit said. In 2018, the U.S. Patent Trial and Appeal Board granted a petition by generic drug manufacturer Amneal challenging the key Alkermes patent. Value Drug’s lawsuit said Alkermes induced Amneal to settle hours before the start of a trial in that proceeding. Alkermes provided Amneal a license to market a generic Vivitrol "beginning sometime in 2028 or earlier under certain circumstances,” according to Value Drug's lawsuit. The lawsuit also said Alkermes convinced Teva Pharmaceuticals to settle a lawsuit it had filed in 2020 challenging the patent. Teva agreed to postpone its generic launch until 2027, according to the lawsuit. Value Drug said a generic Vivitrol “is the kind of product the FDA would typically prioritize for expedited approval,” citing the opioid epidemic in the United States. The case is Value Drug Company v. Alkermes Inc and Alkermes Pharma Ireland Limited, U.S. District Court for the District of Massachusetts, No. 1:25-cv-12872-GAO. (Reporting by Mike Scarcella)