---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-326822"
form_type: "8-K"
ticker: "MIRM"
cik: "0001759425"
company_name: "Mirum Pharmaceuticals, Inc."
filed_at: "2025-12-19T23:59:59+00:00"
generated_at: "2026-05-16T12:36:59.952716+00:00"
event_type: "litigation"
sentiment: "negative"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001193125-25-326822
- form_type: 8-K
- ticker: MIRM
- cik: 0001759425
- company_name: Mirum Pharmaceuticals, Inc.
- filed_at: 2025-12-19T23:59:59+00:00
- event_type: litigation
- sentiment: negative
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1759425/000119312525326822/0001193125-25-326822-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1759425/000119312525326822/d32908d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-326822
- JSON: https://secwatch.observer/filing/0001193125-25-326822.json
- Plain text: https://secwatch.observer/filing/0001193125-25-326822.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.