Court Removes Injunction on Sun Pharma's LEQSELVI Launch in US
Sun Pharma
Delhi: In a major relief to Sun Pharmaceutical Industries Ltd, the U.S. Court of Appeals for the Federal Circuit has vacated a preliminary injunction that had prevented the Indian drugmaker from launching its autoimmune disorder treatment LEQSELVI (deuruxolitinib) in the United States.
The ruling, which was delivered shortly after an oral hearing on April 9, comes as a major development in the ongoing patent litigation between Sun Pharma and Incyte Corporation.
Sun Pharma informed the exchanges in a regulatory filing that "On April 9, 2025, the U.S. Court of Appeals for the Federal Circuit held an oral argument on the company's appeal of the U.S. District Court for the District of New Jersey's decision that previously granted a preliminary injunction delaying the Company's launch of LEQSELVI (deuruxolitinib) in the U.S."
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Following the hearing, the Federal Circuit acted swiftly. "Shortly after the oral argument concluded, the U.S. Court of Appeals for the Federal Circuit ruled in favour of the company and vacated the preliminary injunction effective immediately," the company stated in the filing.
While the underlying patent litigation with Incyte Corporation continues, Sun Pharma is no longer constrained by a court order preventing the product launch. "The company is no longer under a court order that delays or restricts the company from launching LEQSELVI. The company will disclose LEQSELVI launch plans in due course of time," it added.
LEQSELVI is a therapeutic treatment for an autoimmune condition that results in patchy hair loss, and its launch is expected to mark a significant milestone for Sun Pharma’s specialty drug portfolio in the U.S. market.
Headquartered in Mumbai, Sun Pharma manufactures and sells a wide range of pharmaceutical formulations and active pharmaceutical ingredients (APIs) in over 100 countries. Founded in 1983 by Dilip Shanghvi, Sun Pharma has grown through strategic acquisitions and a focus on both chronic and acute therapies, with a significant presence in markets like the US and emerging economies. Key therapeutic areas include psychiatry, cardiology, gastroenterology, anti-infectives, diabetology, dermatology, and more.
