Mirum Pharmaceuticals, Inc. 8-K

What Happened
Mirum Pharmaceuticals announced it received Paragraph IV Certification Notice Letters from Sandoz, Inc. and later from Annora Pharma Private Limited, Zydus Lifesciences Global FZE and Zenara Pharma Private Limited, each informing Mirum that the sender submitted an ANDA to the FDA seeking approval of a generic version of Livmarli® (maralixibat). On December 19, 2025, Mirum filed patent infringement lawsuits against these four ANDA filers in the U.S. District Court for the District of Delaware, alleging infringement of Mirum’s Orange Book-listed patents for LIVMARLI®.

Key Details

• ANDA filers: Sandoz, Inc.; Annora Pharma Private Limited; Zydus Lifesciences Global FZE; Zenara Pharma Private Limited.
• Product at issue: Livmarli® (maralixibat).
• Action taken: Patent infringement complaints filed December 19, 2025 in the U.S. District Court for the District of Delaware.
• Regulatory impact: The lawsuits trigger a 30-month stay that prevents the FDA from issuing final approval of the ANDAs during that stay period.

Why It Matters
For investors, the filing of these lawsuits is a defensive step to protect Mirum’s marketed product and its Orange Book-listed patents. The immediate, concrete effect is the 30-month stay that halts final FDA approval of the challengers’ ANDAs, delaying potential generic competition while the patent dispute proceeds. Investors should note this creates timing uncertainty around potential generic entry and could affect future revenue and legal costs; monitor Mirum’s future filings for updates on litigation progress and any financial disclosures.