Mirum Pharmaceuticals, Inc. 8-K Filing Summary

Mirum Pharmaceuticals, Inc. has announced that it received Paragraph IV Certification Notice Letters from Sandoz, Inc., Annora Pharma Private Limited, Zydus Lifesciences Global FZE, and Zenara Pharma Private Limited. These companies have submitted Abbreviated New Drug Applications (ANDAs) to the FDA seeking approval for generic versions of Livmarli® (maralixibat). In response, Mirum Pharmaceuticals filed patent infringement lawsuits against these ANDA filers in the U.S. District Court for the District of Delaware on December 19, 2025. The company alleges that the ANDA filers have infringed upon its Orange Book listed patents for Livmarli®. Mirum is seeking an order to prevent the FDA from granting final approval of the ANDAs until the expiration of the Company’s asserted patents. This action results in a 30-month stay on the FDA’s approval process for the generic versions.