Mirum Pharmaceuticals Inc. has filed patent infringement lawsuits against Sandoz, Annora Pharma Private Limited, Zydus Lifesciences Global FZE, and Zenara Pharma Private Limited in the United States District Court for the District of Delaware. The company alleges that the filing of Abbreviated New Drug Applications (ANDAs) by these firms for generic versions of Livmarli infringes on Mirum’s Orange Book listed patents. As a result of the litigation, a 30-month stay has been imposed, preventing the FDA from granting final approval of the generic ANDAs before the expiration of the asserted patents.
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