Teva Wins License to Launch Generic Vivitrol in 2027 After Patent Settlement with Alkermes

Teva Pharmaceuticals, Alkermes, Vivitrol, Patent settlement, Generics

Teva Pharmaceuticals has secured a pivotal victory in a patent dispute settlement with Alkermes, the manufacturer of Vivitrol. This settlement grants Teva an exceptional license to introduce its generic variant of the medication for opioid and alcohol dependence well ahead of the drug’s patent expiration.

The terms of the agreement dictate that Teva can launch its generic version of Vivitrol as early as January 15, 2027, or even sooner under specific customary circumstances. Remarkably, this market entry date is a substantial two years ahead of Vivitrol’s patent expiration in 2029, providing Teva with a strategic advantage in the pharmaceutical landscape.

While exact specifics of the settlement remain undisclosed, Alkermes initiated the legal action against Teva for patent infringement in 2020. The litigation progressed to a trial stage in March, culminating in this settlement that mandates both companies to jointly seek the dismissal of the litigation from the US District Court for the District of New Jersey.

Vivitrol, a long-acting intramuscular injectable medication, garnered its maiden FDA approval in 2006, initially intended for treating alcohol dependence. Subsequently, its label was expanded in 2010 to encompass opioid dependence treatment, a factor that substantially fueled its commercial success.

Alkermes, however, faced scrutiny for its assertive marketing practices amidst the opioid epidemic. In 2017, then-Senator Kamala Harris initiated an investigation into the company’s aggressive lobbying and marketing campaign. Further complicating matters, the FDA’s Office of Prescription Drug Promotion issued Alkermes a stern warning letter for omitting crucial safety risks in one of its advertisements.

Financially, Vivitrol contributed significantly to Alkermes’ revenue stream, amassing $379.5 million in sales last year—an impressive 10% increase from 2021. The company’s projections for 2023 suggest anticipated sales ranging from $380 million to $410 million, underscoring the medication’s continued commercial prominence.

Teva’s triumph in this patent dispute not only shapes the competitive landscape but also underscores the dynamic and complex environment within the pharmaceutical industry. The accelerated introduction of the generic version of Vivitrol positions Teva strategically, while also emphasizing the evolving challenges in the opioid crisis context.

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