After settling a patent case with Vivitrol maker Alkermes, Teva has gained a license to launch its generic version of the opioid dependence and alcohol dependence med years ahead of the drug's patent expiration.
Under the agreement, Teva can launch its generic version of Vivitrol on Jan. 15, 2027, or earlier under “certain customary circumstances.” The market entry date is two years before Vivitrol’s 2029 patent expiration.
Other details of the settlement were not disclosed.
Alkermes first sued Teva for infringement in 2020, and the litigation progressed to a trial in March. Now, the companies will request that the U.S. District Court for the District of New Jersey dismiss the litigation, Alkermes said in its statement.
Vivitrol, an extended-release intramuscular injectable, won its first FDA approval in 2006 for alcohol dependence. Its label grew to include opioid dependence in 2010, providing a major tailwind for sales.
More recently, Alkermes landed in hot water for its aggressive marketing of the medicine amid the opioid epidemic.
Two years after then-Senator Kamala Harris launched an investigation into the company’s “aggressive lobbying and marketing campaign” in 2017, the FDA’s Office of Prescription Drug Promotion issued Alkermes a serious warning letter for omitting safety risks from one of its ads.
Vivitrol brought in $379.5 million for Alkermes last year, a 10% increase from 2021. The company expects full-year 2023 sales to come in between $380 million and $410 million.