---
schema_version: "secwatch.filing_event.v1"
accession: "0001759425-25-000057"
form_type: "8-K"
ticker: "MIRM"
cik: "0001759425"
company_name: "Mirum Pharmaceuticals, Inc."
filed_at: "2025-11-17T23:59:59+00:00"
generated_at: "2026-05-16T19:21:10.445369+00:00"
event_type: "litigation"
sentiment: "negative"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Mirum receives Sandoz Paragraph IV notice challenging Livmarli patents; plans to sue

## Summary
- Sandoz filed ANDA seeking FDA approval for generic Livmarli (maralixibat).
- Sandoz alleges five Livmarli Orange Book patents are invalid or not infringed.
- Mirum has 45 days to sue, triggering a 30-month FDA approval stay.
- Mirum expects additional Paragraph IV notices from other ANDA filers.
- Company vows to vigorously enforce IP and seek a permanent injunction.

## SEC filing metadata
- accession: 0001759425-25-000057
- form_type: 8-K
- ticker: MIRM
- cik: 0001759425
- company_name: Mirum Pharmaceuticals, Inc.
- filed_at: 2025-11-17T23:59:59+00:00
- event_type: litigation
- sentiment: negative
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1759425/000175942525000057/0001759425-25-000057-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1759425/000175942525000057/mirm-20251117.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001759425-25-000057
- JSON: https://secwatch.observer/filing/0001759425-25-000057.json
- Plain text: https://secwatch.observer/filing/0001759425-25-000057.txt

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