Alkermes has settled a lawsuit with Teva Pharmaceuticals establishing patent protection for the opioid and alcohol dependence treatment Vivitrol (extended-release injectable suspension of naltrexone) for four more years.
Alkermes had filed a patent infringement lawsuit with the New Jersey District Court against Teva, in response to Teva’s application to the US Food and Drug Administration (FDA) seeking approval for a generic version of Vivitrol in September 2020.
The trial concluded in March 2023. Although the details of the settlement were not disclosed by either party, Alkermes has agreed to allow Teva to market a generic version of Vivitrol in the US after 15 January 2027 or earlier, contingent on yet undisclosed circumstances.
Both companies are planning to file the settlement for review to the US Federal Trade Commission and the US Department of Justice. Additionally, the companies will file a proposed stipulated consent judgment and injunction with the New Jersey District Court to dismiss the pending litigation.
Vivitrol is It is Alkermes's highest-grossing drug and is projected to generate up to $410m in sales in 2023, as per the company’s projections.
The news follows Alkermes winning two arbitrations against Janssen Pharmaceuticals for back royalties for drug licensing worth $194m. The royalties were for the 2022 US drug sales for the HIV retroviral combination therapy, Cabenuva (cabotegravir/rilpivirine), and three antipsychotic Invega (paliperidone palmitate) medications.
Alkermes also plans to separate its oncology division into a separate, publicly traded company, Oncology Co., by the end of 2023. To that end, it submitted a draft Form 10 registration statement to the US Securities and Exchange Commission in April 2023. The company’s lead immuno-oncology candidate, nemvaleukin alfa, is currently in Phase II clinical development for mucosal melanoma and platinum-resistant ovarian cancer.
Other marketed drugs in Alkermes’s neurology drug portfolio include the atypical antipsychotic Aristada (aripiprazole lauroxil), and the combination therapy Lybalvi (olanzapine/samidorphan) for the treatment of bipolar 1 disorder.
