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

UroGen Pharma Ltd.

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.

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