A major update is here—Sun Pharmaceutical Industries, one of India’s largest drugmakers, has officially launched its much-awaited hair loss treatment Leqselvi™ (deuruxolitinib) 8 mg tablets in the U.S. This launch comes after the settlement of a patent infringement case with Delaware-based Incyte Corporation. Sun Pharma Leqselvi US launch is expected to make waves in the competitive market for alopecia areata treatments. However, we need to know more about the settlement process to fully understand this update. However, to fully understand this update, it’s important to look more closely at the settlement process that made the launch possible.
What Sparked the Patent Dispute Between Sun Pharma and Incyte?
If we look at the background, Sun Pharma acquired the rights to Leqselvi in 2023 through its $576 million acquisition of Concert Pharmaceuticals. In July 2024, the U.S. Food and Drug Administration (FDA) approved the drug.
Shortly after this approval, Incyte Corporation filed a patent infringement lawsuit in the U.S., claiming that Leqselvi violated its intellectual property rights (IPR). In November 2024, a U.S. district court issued an order temporarily stopping Sun Pharma from selling Leqselvi until the final judgment comes.
But here the tweak came. In April 2025, the U.S. Court of Appeals lifted the injunction order, but the case filed by Incyte Corporation was still ongoing. Such prolonged legal uncertainty was not ideal for a company planning sustained growth in the U.S. market. Both companies reached an agreement in July 2025. Under this arrangement, Sun Pharma obtained a non-exclusive right to use Incyte’s patent in return for an initial payment and continuing royalty fees until the patent’s expiry. Both sides also consented to withdraw all outstanding legal actions.
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What Is Leqselvi™ (Deuruxolitinib), and How Does It Work?
Leqselvi™ (deuruxolitinib) is a pill designed to help people with severe alopecia areata, a condition where the body’s immune system attacks hair follicles, causing patchy or even complete hair loss. It works by blocking certain enzymes (JAK1 and JAK2) that play a role in this immune reaction, helping to stop hair loss and encourage regrowth. Approved by the U.S. FDA in July 2024 for adults, it’s shown promising results in clinical trials, with many patients seeing noticeable hair regrowth within a few months.
What Does the Settlement Mean for Sun Pharma’s Future?
If we look at the settlement process, Sun Pharma and Incyte Corporation have resolved their dispute over Leqselvi through an out-of-court agreement. This settlement grants Sun Pharma the rights to market Leqselvi in the U.S.—a potentially huge market for the company.
Key Points from the Settlement:
Type of Agreement:
Out-of-court settlement ending the Leqselvi patent litigation.
Patent License:
- Limited, non-exclusive rights to U.S. Patent No. 9,662,335 and related patents.
- Applies to oral use of duruxolitinib for non-hematology/oncology indications, including alopecia areata.
Financial Terms:
- Upfront payment to Incyte.
- Ongoing royalty payments until the patents expire.
- Exact amounts remain confidential.
Legal Resolution:
- Mutual withdrawal of all pending lawsuits in the U.S. District Court for the District of New Jersey.
Impact:
- Removes a major legal hurdle for Sun Pharma.
- Allows immediate U.S. launch of Leqselvi.
- Strengthens Sun Pharma’s specialty portfolio and U.S. market presence.
Conclusion
Leqselvi marks a major step forward in treating severe alopecia areata, offering hope to patients with few effective options. Its U.S. debut follows the resolution of a high-stakes patent dispute with Incyte, a settlement that not only cleared legal barriers but also ensured Sun Pharma’s entry into a lucrative market.