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UroGen Pharma Shares (NASDAQ:URGN) fell premarket Friday after Teva Pharmaceutical (NYSE:TEVA) has submitted a marketing application seeking FDA approval for a generic version of US biotech Jelmyto’s bladder cancer therapy.
According to a document filed with the SEC by UroGen (URGN) Friday, Teva (TEVA) The Abbreviated New Drug Application (ANDA) seeks FDA approval for a pyelocaliceal solution from Jelmyto.
The Israeli pharmaceutical company notified URGN that the company’s generic version will not infringe intellectual property rights related to Jelmyto because two of its patents listed in the FDA’s Orange Book “are invalid, unenforceable, or will not be infringed.” .
“We are just beginning to capitalize on the market opportunities of what we have pioneered, and clearly, others are seeing the potential,” noted Liz Barrett, CEO of URGN.
“As a result, we are prepared for such filing and are confident in the strength and breadth of our patent portfolio.”
Jelmyto, URGN’s first commercial product, was launched in the United States in June 2020. The drug identified as mitomycin in generic terms generated net sales for the company of $59.2 million in the first three quarters of 2023, with an annual growth of approximately 28%.