Mirum Pharmaceuticals Files Patent Infringement Lawsuits To Block FDA Approval Of Generic Livmarli Following ANDA Filings By Sandoz, Annora, Zydus, Zenara

In November 2025, Mirum Pharmaceuticals, Inc. (the "Company") announced that it received a Paragraph IV Certification Notice Letter (the "Notice Letter") from Sandoz, Inc. ("Sandoz"), providing notification to the Company that Sandoz has submitted an Abbreviated New Drug Application ("ANDA") to the U.S. Food and Drug Administration ("FDA"), seeking approval of a generic version of Livmarli® (maralixibat). The Company subsequently received additional Notice Letters from Annora Pharma Private Limited, Zydus Lifesciences Global FZE and Zenara Pharma Private Limited (together with Sandoz, the "ANDA Filers").

On December 19, 2025, the Company filed patent infringement suits against the ANDA Filers in the United States District Court for the District of Delaware. The complaints allege that by filing their ANDAs, the ANDA Filers have infringed the Company's Orange Book listed patents for LIVMARLI®, and seek an order that the effective date of FDA approval of each of the ANDAs shall be a date no earlier than the expiration of the last to expire of the asserted patents. As a result of these lawsuits, a 30-month stay prevents the FDA from issuing final approval of the ANDA Filers' ANDAs.