Mirum Pharmaceuticals sues Sandoz, Annora, Zydus, Zenara over generic Livmarli ANDAs

Mirum Pharmaceuticals, Inc.

Received Paragraph IV notice letters from Sandoz, Annora Pharma, Zydus Lifesciences, and Zenara Pharma seeking generic Livmarli.
Filed patent infringement suits on December 19, 2025 in U.S. District Court for Delaware.
Suits assert infringement of Orange Book patents for LIVMARLI (maralixibat).
Suits seek FDA approval no earlier than expiration of last asserted patent.
30-month stay prevents FDA from granting final approval of the ANDAs.

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