Court of Appeals Lifts Injunction, Removing Barrier to U.S. Drug Rollout
Sun Pharmaceutical Industries Ltd. has received a favorable verdict from the U.S. Court of Appeals for the Federal Circuit, effectively removing a critical legal obstacle that had delayed the launch of its key specialty drug, Leqselvi (deuruxolitinib), in the American market. In a regulatory filing dated April 10, the company announced that the appellate court has vacated the preliminary injunction, allowing the company to move forward with commercialization plans for Leqselvi in the United States.
The litigation between Sun Pharma and Incyte Corporation—which originally led to the issuance of the injunction—remains ongoing. However, the lifting of the injunction is immediate, granting Sun Pharma the legal leeway to proceed with its U.S. rollout strategy for the drug. While the company has yet to officially declare its launch timeline, the decision marks a pivotal step in its broader U.S. specialty pharmaceutical expansion.
Highlights:
U.S. Court of Appeals lifts injunction on Sun Pharma’s Leqselvi launch.
The ruling allows immediate action toward commercialization in the U.S.
Litigation with Incyte Corporation over patent infringement is ongoing.
Launch plans to be announced soon, according to company filing.
Drug Positioned as Strategic Growth Driver Following $576 Million Acquisition
Sun Pharma acquired Leqselvi as part of its $576 million acquisition of Concert Pharmaceuticals in March 2023. The company has identified deuruxolitinib, the active ingredient in Leqselvi, as a strategic asset in its specialty drugs portfolio. The drug is approved by the U.S. Food and Drug Administration (FDA) for the treatment of alopecia areata, an autoimmune disease characterized by sudden and often unpredictable hair loss.
According to the company’s internal projections and external market analysis, Leqselvi is expected to contribute approximately $90 million in revenues during FY26, with the figure climbing to $125 million by FY27. These expectations make Leqselvi one of the most important launches for Sun Pharma in the U.S., particularly as the firm intensifies its shift toward innovative, high-margin specialty products in developed markets.
Dilip Shanghvi, Managing Director and Founder of Sun Pharma, had earlier emphasized the importance of the court’s ruling. During an investor interaction in February, he stated that the company would not proceed with the drug’s launch until the preliminary injunction was lifted or overturned, highlighting the centrality of Leqselvi to Sun Pharma’s long-term growth strategy in the U.S.
Highlights:
Leqselvi acquired via $576 million Concert Pharma deal in 2023.
FDA-approved for treatment of alopecia areata, a hair loss condition.
Expected to generate $90 million in FY26, $125 million in FY27.
Considered a flagship product in Sun Pharma’s U.S. specialty portfolio.
Incyte Patent Dispute Background and Legal Developments
The dispute over Leqselvi’s launch stems from a patent infringement lawsuit filed by Incyte Corporation, which contends that Sun Pharma’s deuruxolitinib formulation infringes on its existing patent for ruxolitinib, a structurally and functionally similar treatment. Incyte’s patent is valid until December 2026, and in November 2024, the U.S. District Court for the District of New Jersey granted Incyte a preliminary injunction. This ruling barred Sun Pharma from launching Leqselvi until either the resolution of the legal case or the expiration of the contested patent.
Sun Pharma had appealed the district court’s ruling to the Federal Circuit, arguing that the injunction was unjustified and unduly delayed its commercial strategy. The appellate court’s decision to vacate the injunction represents a major legal victory for Sun Pharma and may set a precedent for similar patent-related disputes in the pharmaceutical industry.
While the underlying case remains active, the removal of the injunction allows Sun Pharma to potentially introduce Leqselvi into the U.S. market well before the December 2026 patent expiration—providing a competitive advantage and early-mover benefit in a growing treatment category.
Highlights:
Incyte alleged Leqselvi infringes on its ruxolitinib patent valid till Dec 2026.
District court granted injunction in November 2024 barring drug’s launch.
Appeals court lifted injunction; lawsuit continues but restrictions ended.
Legal win enables Sun Pharma to proceed with pre-expiry launch plans.
