secwatch.observer — SEC 8-K summary
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Issuer:     Mirum Pharmaceuticals, Inc. (MIRM)
CIK:        0001759425
Form:       8-K
Filed at:   2025-12-19T23:59:59+00:00
Accession:  0001193125-25-326822
Event type: litigation
Sentiment:  negative
Materiality: 0.85
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1759425/000119312525326822/0001193125-25-326822-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1759425/000119312525326822/d32908d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-326822

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer