secwatch.observer — SEC 8-K summary
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Issuer:     UroGen Pharma Ltd. (URGN)
CIK:        0001668243
Form:       8-K
Filed at:   2024-03-01T23:59:59+00:00
Accession:  0001193125-24-054393
Event type: litigation
Sentiment:  negative
Materiality: 0.75
Item codes: 7.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1668243/000119312524054393/0001193125-24-054393-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1668243/000119312524054393/d791127d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-24-054393

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