The U.S. Court of Appeals for the Federal Circuit has ruled in favor of Sun Pharmaceutical Industries Ltd., vacating a preliminary injunction that had prevented the company from launching its alopecia areata treatment Leqselvi (deuruxolitinib) in the United States.
The favorable ruling, announced on April 10, 2025, comes after Sun Pharma appealed the U.S. District Court for the District of New Jersey's earlier decision that had granted Incyte Corporation a preliminary injunction delaying the launch. While the patent infringement litigation between the two companies continues, Sun Pharma is no longer restricted from bringing the drug to market.
"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," Sun Pharma stated in a regulatory filing.
Strategic Importance for Sun Pharma
The ruling represents a significant victory for Sun Pharma, which acquired Leqselvi through its $576 million buyout of Concert Pharmaceuticals in March 2023. The company has positioned the drug as a potential "best-in-class" treatment and a cornerstone of its growing specialty portfolio.
Dilip Shanghvi, Sun Pharma's founder and managing director, had previously emphasized the importance of this case in February, stating, "The judgment is to validate the existing judgment, and we can't launch till the time we get a more favorable judgment."
According to market estimates, Leqselvi is projected to contribute significantly to Sun Pharma's revenue, with analysts forecasting $90 million in sales for FY26 and $125 million in FY27.
The Patent Dispute
The legal battle centers on Incyte Corporation's claim that Leqselvi infringes on its patent for ruxolitinib, a similar drug with patent protection until December 2026. In November 2024, the U.S. District Court of New Jersey granted Incyte a preliminary injunction that prevented Sun Pharma from launching Leqselvi until either a favorable hearing outcome or the expiration of Incyte's patent.
The recent appellate court decision removes this restriction, though the underlying patent infringement case remains ongoing.
Addressing an Unmet Medical Need
Leqselvi received FDA approval last year for the treatment of alopecia areata, an autoimmune condition that causes patchy hair loss. The condition affects up to 2.5% of the U.S. population, with limited treatment options currently available.
Sun Pharma has secured five-year marketing exclusivity for Leqselvi in the U.S., and there are no pending regulatory queries from the FDA regarding the product.
Growth of Sun Pharma's Specialty Business
The potential launch of Leqselvi comes at a time when Sun Pharma's global specialty business is experiencing significant growth. The specialty segment, which derives the majority of its sales from the U.S. market, surpassed the $1 billion sales milestone in FY24, growing 19% year-over-year to reach $1.04 billion.
This specialty business now contributes approximately 18% of Sun Pharma's total revenue, highlighting the company's successful diversification strategy beyond generic medications into higher-margin specialty pharmaceuticals.
The court's decision to lift the injunction represents a critical opportunity for Sun Pharma to further strengthen its position in the specialty pharmaceutical market while addressing an important unmet medical need for patients with alopecia areata.
