RedHill Biopharma pronounces US patent litigation decision in response to a generic model of Movantik

Under the terms of the Settlement Agreement, MSN Pharmaceuticals, Inc. may not sell a generic version of Movantik in the United States until October 1, 2030 (subject to FDA approval) or earlier under certain circumstances

Ltd. () announced a solution to patent disputes in the US in response to a generic version of Movantik (Naloxegol), to which the company acquired worldwide rights excluding Europe and Canada from April 2020.

In a statement, the company announced that RedHill Biopharma Inc., AstraZeneca AB and AstraZenca Pharmaceuticals LP have entered into an arrangement and license agreement with MSN Pharmaceuticals, Inc. and MSN Laboratories PVT. GMBH. U.S. patent litigation resolution in response to MSN’s Abbreviated New Drug Application (ANDA), which granted the U.S. Food and Drug Administration (FDA) approval to commercialize the generic version of Movantik, a treatment for opioid-induced constipation in adults, requested.

Under the terms of the Settlement Agreement, MSN may not sell a generic version of Movantik in the United States until October 1, 2030 (subject to FDA approval) or earlier under certain circumstances.

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RedHiill said the parties to the settlement agreement had also agreed to file an agreement and dismissal notice with the US. Delaware District Court to resolve this MSN litigation.

As required by law, the parties will submit the settlement agreement to the US Federal Trade Commission and the US Department of Justice for review.

The company added that the settlement with MSN does not end RedHill’s ongoing litigation against the other two ANDA claimants.

RedHill is a specialized biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. In addition to Movantik, RedHill is promoting the other two gastrointestinal drugs – Talicia, used to treat Helicobacter pylori (H. pylori) infections in adults; and Aemcolo, for the treatment of adult travelers’ diarrhea.

RedHill’s key late-stage clinical development programs include: (i) RHB-204 with an ongoing Phase 3 study in non-tuberculous pulmonary mycobacteria (NTM); (ii) Opaganib (Yeliva), a world-class selective SK2 inhibitor targeting multiple indications, with a phase 2/3 program for coronavirus (COVID-19) and phase 2 trials in prostate cancer and cholangiocarcinoma; (iii) RHB-107 (upamostat), a serine protease inhibitor in a US Phase 2/3 study for symptomatic COVID-19 targeting several other cancers and gastrointestinal inflammatory diseases; (iv) RHB-104 with positive results in an initial phase 3 study in Crohn’s disease; (v) RHB-102 (Bekinda) with positive results from a phase 3 study for acute gastroenteritis and gastritis and positive results from a phase 2 study for IBS-D; and (vi) RHB-106, an encapsulated bowel preparation.

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