Dublin-based Alkermes has settled an ongoing lawsuit with Teva Pharmaceuticals, paving the way for the Israeli multinational pharma company to launch its own generic counterpart to Alkermes’ injectable alcohol and opioid dependence drug.
The two companies have been sparring in a New Jersey court since 2020, when Teva Pharmaceuticals claimed that a patent that could protect Vivitrol until 2029 is invalid. Teva at the time filed an abbreviated new drug application for a generic version of Vivitrol.
In Wednesday’s announcement, Alkermes said it had “granted Teva a license under U.S. Patent No. 7,919,499 to market a generic version of Vivitrol in the United States beginning January 15, 2027, or earlier under certain customary circumstances.” No further details were released and the companies still have to submit the settlement agreement to the Federal Trade Commission and the Department of Justice.
While the news marks an end to Alkermes’ monopoly, it’s not catastrophic for the pharma company, which received a nearly $250 million boost after winning a suit against Johnson & Johnson in July 2023. The suit focused on back royalties and interest for technologies Alkermes provided to J&J for use in various drugs. J&J tried to partially terminate the deal on the grounds it was no longer using the intellectual property.
Alkermes Chief Commercial Officer Todd Nichols told analysts on a company earnings call in July that even if the suit didn’t go their way, the drug will remain an important and profitable product for the company.
“We have complex manufacturing, the fulfillment channels are complex, the settings of care are complex and there's not one setting that actually dominates the market. Anyone coming into the market would have to have a deep understanding of how to commercialize,” Nichols said. “We believe we are well positioned to continue to drive Vivitrol and also defend if a competitor came into the market.”
Vivitrol sales of $102.1 million—up by 6% from the first quarter—accounted for about one-sixth of the company’s total second-quarter sales this year, keeping the drug on track to generate between $380 million and $410 million this year. The company has as-yet announced no changes to its 2023-2024 market strategy for Vivitrol.
The drug is an extended-release form of naltrexone, an opioid receptor agonist which works by inhibiting the rewarding and intoxicating effects of opioids and alcohol.
Alkermes also has “a portfolio of proprietary commercial products focused on alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of product candidates in development for neurological disorders and cancer,” according to the company, though it’s also considering spinning out its oncology business into an independent, publicly-traded company.
https://www.biospace.com/article/alkermes-settles-patent-lawsuit-with-teva-over-generic-vivitrol/
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