Sun Pharma’s LEQSELVI Released From Patent Litigation Hold

There was good news for Sun Pharmaceutical Industries, Ltd. (Sun Pharma) and the alopecia areata community in the form of a legal decision announced on April 9, 2025. The U.S. Court of Appeals for the Federal Circuit ruled in favor of Sun Pharma and lifted a preliminary injunction on the company, allowing the company to proceed with the commercial launch of its drug, LEQSELVI™ (deuruxolitinib). 

LEQSELVI was approved by the U.S. Food and Drug Administration (FDA) in July 2024 for the treatment of severe alopecia areata in adults in July 2024, becoming the third FDA-approved treatment for the autoimmune disease. However, its commercial launch was delayed due to ongoing patent litigation between Sun Pharma and Incyte Corporation, the patent holder for a similar drug, ruxolitinib, as reported by NAAF in November of last year. 

In a filing on the Bombay Stock Exchange, following the court’s decision, Sun Pharma stated that it is no longer restricted from launching LEQSELVI. The company has not yet announced a timeline for the commercial rollout. NAAF will continue to share updates as they become available. 

Read more: Sun Pharma overturns block on alopecia drug launch in US