UroGen Pharma Settles Patent Litigation with Teva, Secures JELMYTO Protection Until 2030
核心洞察
UroGen Pharma has reached a settlement agreement with Teva Pharmaceuticals that resolves patent litigation over JELMYTO, granting Teva a non-exclusive license to sell its generic version beginning September 15, 2030.
The agreement preserves nearly all of UroGen's patent protection period for JELMYTO, which has regulatory exclusivity through April 2027 and Orange Book-listed patents expiring January 20, 2031.
JELMYTO is approved for treating low-grade upper tract urothelial cancer (搜索) using UroGen's proprietary RTGel (搜索) reverse-thermal hydrogel technology that enables sustained drug release.
UroGen Pharma Ltd. has announced a settlement and license agreement with Teva Pharmaceuticals that resolves patent litigation over JELMYTO® (mitomycin) for pyelocalyceal solution, securing patent protection for the innovative cancer treatment until 2030. The agreement grants Teva a non-exclusive license to sell its generic version of JELMYTO beginning September 15, 2030, if approved by the FDA.
Patent Protection Preserved
The settlement preserves nearly all of UroGen's patent protection period for JELMYTO, which maintains regulatory exclusivity through April 15, 2027, and is covered by Orange Book-listed patents expiring on January 20, 2031. The negotiated license date of September 15, 2030, reflects the strength of the company's intellectual property portfolio.
"We believe this resolution underscores the innovation behind our RTGel (搜索)® technology and the strength of our intellectual property portfolio," said Liz Barrett, President and Chief Executive Officer of UroGen. "We look forward to continuing to execute on our mission to transform paradigms in uro-oncology with our innovative treatments."
JELMYTO's Innovative Technology
JELMYTO is a mitomycin-containing reverse thermal gel approved for treating adult patients with low-grade upper tract urothelial cancer (搜索) (LG-UTUC). The drug contains 4 mg mitomycin per mL gel and utilizes UroGen's proprietary RTGel (搜索) reverse-thermal hydrogel technology. This innovative delivery system is a viscous liquid when cooled that becomes a semi-solid gel at body temperature, slowly dissolving over four to six hours after instillation.
The RTGel (搜索) technology allows the initial liquid to coat and conform to the upper urinary tract anatomy, while the eventual semisolid gel enables chemoablative therapy to remain in the collecting system for four to six hours without being immediately diluted or washed away by urine flow. JELMYTO can be administered retrograde via ureteral catheter or antegrade through a nephrostomy tube.
Addressing Unmet Medical Need
Upper tract urothelial cancer (搜索) represents a significant medical challenge, with urothelial cancer (搜索) being the ninth most common cancer globally and the eighth most lethal neoplasm in men in the United States. Between five and ten percent of primary urothelial cancers originate in the ureter or renal pelvis, collectively referred to as UTUC. In the U.S., there are approximately 6,000 to 7,000 new or recurrent LG-UTUC patients annually.
Most cases are diagnosed in patients over 70 years old, and these older patients often have multiple comorbidities. Treatment options for UTUC are limited, with the most common being endoscopic surgery or nephroureterectomy (removal of the entire kidney and ureter). Treatment with endoscopic surgery can be associated with a high rate of recurrence and relapse.
Legal Resolution
The litigation arose from Teva's submission of an Abbreviated New Drug Application (ANDA) to the FDA seeking approval to market a generic version of JELMYTO prior to the expiration of relevant UroGen patents. According to the FDA's public database, Teva's ANDA has not received tentative approval. Under the settlement terms, the parties will ask the court to dismiss the pending patent litigation with prejudice.
As required by law, the companies will submit the agreement to the U.S. Federal Trade Commission and U.S. Department of Justice for review. The settlement allows UroGen to maintain market exclusivity for JELMYTO while providing a clear pathway for generic competition after patent expiration.