Patent Dispute Ends As UroGen And Teva Reach Agreement On JELMYTO Generic Launch: Here's What Changed!

UroGen Pharma Ltd., a biotechnology company focused on developing and commercializing innovative treatments for urothelial and specialty cancers, has announced a settlement and licensing agreement with Teva Pharmaceuticals, Inc. and Teva Pharmaceuticals USA, Inc. The agreement resolves an ongoing patent dispute related to Teva’s attempt to develop a generic version of UroGen’s cancer treatment, JELMYTO® (mitomycin) for pyelocalyceal solution.

The litigation began after Teva submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA), seeking approval to market a generic form of JELMYTO before the expiration of UroGen’s existing patents. According to the FDA’s public records, Teva’s generic application has not yet received tentative approval.

Under the terms of the agreement, UroGen has granted Teva a non-exclusive license that would allow the company to launch its generic version of JELMYTO beginning September 15, 2030, provided it receives FDA approval. The agreement also includes certain standard conditions that could affect the launch timeline under specific circumstances.

As part of the settlement, both companies have agreed to request the dismissal of the ongoing patent litigation with prejudice, bringing the legal dispute to a close.

Commenting on the agreement, Liz Barrett, President and Chief Executive Officer of UroGen Pharma, stated that the resolution highlights both the value of the company’s proprietary RTGel® technology and the strength of its intellectual property portfolio. She added that UroGen remains focused on advancing innovative therapies and continuing its mission to improve treatment options in the field of uro-oncology.

JELMYTO currently benefits from regulatory exclusivity in the United States through April 15, 2027. In addition, the therapy is protected by patents listed in the FDA’s Orange Book, which are scheduled to expire on January 20, 2031. The agreed licensing date allows UroGen to retain nearly the entire remaining patent protection period, reinforcing the company’s confidence in its intellectual property rights.

In accordance with legal requirements, the settlement agreement will be submitted to both the U.S. Federal Trade Commission (FTC) and the U.S. Department of Justice (DOJ) for review.