---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-24-054393"
form_type: "8-K"
ticker: "URGN"
cik: "0001668243"
company_name: "UroGen Pharma Ltd."
filed_at: "2024-03-01T23:59:59+00:00"
generated_at: "2026-06-05T05:36:26.337537+00:00"
event_type: "litigation"
sentiment: "negative"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# UroGen receives Teva Paragraph IV notice challenging two Jelmyto patents expiring 2031

## Summary
- Teva filed ANDA seeking FDA approval for a generic version of Jelmyto (mitomycin) for pyelocaliceal solution.
- Teva alleges U.S. Patent Nos. 9,040,074 and 9,950,069 (expire January 2031) are invalid, unenforceable, or not infringed.
- CEO Liz Barrett states UroGen is prepared and confident in the strength and breadth of its patent portfolio.
- This is the first Paragraph IV challenge to Jelmyto; litigation under the Hatch-Waxman Act expected.

## SEC filing metadata
- accession: 0001193125-24-054393
- form_type: 8-K
- ticker: URGN
- cik: 0001668243
- company_name: UroGen Pharma Ltd.
- filed_at: 2024-03-01T23:59:59+00:00
- event_type: litigation
- sentiment: negative
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1668243/000119312524054393/0001193125-24-054393-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1668243/000119312524054393/d791127d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-24-054393
- JSON: https://secwatch.observer/filing/0001193125-24-054393.json
- Plain text: https://secwatch.observer/filing/0001193125-24-054393.txt

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