UroGen settles JELMYTO patent litigation with Teva

UroGen Pharma Ltd. (NASDAQ: URGN) announced a settlement agreement with Teva Pharmaceuticals resolving patent litigation related to JELMYTO (mitomycin) for pyelocalyceal solution. The agreement grants Teva a non-exclusive license to sell its generic version of JELMYTO beginning September 15, 2030, if approved by the FDA.

The litigation began after Teva submitted an Abbreviated New Drug Application seeking approval to market a generic version of JELMYTO before UroGen's relevant patents expire. According to the FDA's public database, Teva's application has not received tentative approval.

Under the settlement terms, both parties will ask the court to dismiss the pending patent litigation with prejudice. The companies must submit the agreement to the U.S. Federal Trade Commission and U.S. Department of Justice for review as required by law.

JELMYTO has regulatory exclusivity through April 15, 2027, and is covered by Orange Book-listed patents expiring January 20, 2031. The negotiated license date of September 15, 2030, preserves most of the patent protection period.

"We believe this resolution underscores the innovation behind our RTGel technology and the strength of our intellectual property portfolio," said Liz Barrett, President and Chief Executive Officer of UroGen.

JELMYTO is approved for treating adult patients with low-grade Upper Tract Urothelial Cancer. The drug uses UroGen's reverse thermal gel technology, which becomes semi-solid at body temperature and dissolves over four to six hours after administration.

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