Mikele Bicolli
Mar 1, 2024

UroGen Pharma Faces Paragraph IV Challenge as Teva Pursues Generic Jelmyto Approval

ANDA Litigation

Shares of UroGen Pharma (NASDAQ: URGN) took a minor premarket hit following news that Teva Pharmaceutical (NYSE: TEVA) has submitted an application seeking FDA approval for a generic version of UroGen's bladder cancer therapy, Jelmyto. The move by Teva comes as they aim to enter the market with their own version of the drug, potentially posing a challenge to UroGen's market position.

Teva's Challenge:
Teva's Abbreviated New Drug Application (ANDA) targets a pyelocaliceal solution of Jelmyto, according to a filing with the U.S. Securities and Exchange Commission (SEC). In their communication to UroGen, Teva asserts that their generic version will not infringe on intellectual property (IP) rights associated with Jelmyto. They claim that two patents listed in the FDA Orange Book for Jelmyto are either invalid, unenforceable, or will not be infringed upon by their product.

UroGen's Response:
In response to Teva's challenge, UroGen's CEO, Liz Barrett, expressed confidence in the strength of their patent portfolio and the potential of their pioneering work in urothelial cancer treatment. "We’ve known it was only a matter of time before others came to recognize what we’ve known for a very long time – UroGen is on the forefront of changing how urothelial cancers are treated," Barrett stated. "We are only at the beginning of tapping into the market opportunity of what we’ve pioneered and clearly, others are now seeing the potential. Accordingly, we are prepared for such a filing and feel confident in the strength and breadth of our patent portfolio." Despite the looming competition, Barrett remains optimistic about the market opportunity for Jelmyto and asserts that UroGen is well-prepared to address the filing by Teva.

Jelmyto's Market Performance: 
Jelmyto, UroGen's flagship product, was launched in the U.S. market in June 2020. The drug, known generically as mitomycin, has shown promising growth, generating $59.2 million in revenue for the company in third quarter of 2023, with a year-over-year growth rate of approximately 30%. However, Teva's entry into the market with a generic alternative could potentially disrupt UroGen's revenue stream from Jelmyto.