Travere Therapeutics (Nasdaq: TVTX), headquartered in San Diego, received a notice of allowance from the US Patent and Trademark Office for application No. 19/253,088, directed to certain methods of using Filspari (sparsentan) in IgA nephropathy, with expected coverage extending to October 2037. The company intends to list the patent in the FDA’s Orange Book upon formal grant, establishing Hatch-Waxman protections for Filspari.
The application, titled “Biphenyl Sulfonamide Compounds for the Treatment of Kidney Diseases or Disorders,” is a method-of-use patent rather than a composition-of-matter patent, but could still provide commercially meaningful exclusivity. If granted and listed, the patent could delay generic entry through the FDA’s Paragraph IV litigation framework, including potential 30-month stays tied to patent challenges.
Sparsentan is an oral dual endothelin A and angiotensin II type 1 receptor antagonist approved by the US FDA in February 2023 under accelerated approval for reducing proteinuria in adults with primary IgA nephropathy at risk of rapid disease progression, and in April 2026 under full approval for focal segmental glomerulosclerosis. The dual mechanism is intended to reduce proteinuria more effectively than angiotensin pathway blockade alone, which remains a standard treatment backbone in progressive proteinuric kidney disease.
The patent allowance comes as the IgA nephropathy treatment landscape becomes increasingly competitive following recent approvals of targeted therapies in the space. Extending protection into 2037 would provide Travere additional runway to expand the Filspari franchise across adjacent renal indications, including ongoing studies in post-transplant IgAN, FSGS, and pediatric proteinuric glomerular diseases.
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