Sun Pharma, Incyte settle lawsuit over alopecia drug LEQSELVI

Indian pharmaceutical giant Sun Pharma has reached a settlement with U.S.-based biotech firm Incyte Corporation, resolving a legal dispute over the drug LEQSELVI (deuruxolitinib), which is used to treat autoimmune conditions like alopecia areata — a condition that causes sudden hair loss.

The litigation, filed in the United States District Court for the District of New Jersey, involved patent claims over LEQSELVI, a drug developed by Incyte. Sun Pharma had plans to market a version of deuruxolitinib in the U.S., but Incyte accused the company of infringing on its patents.

In a joint statement issued on Monday, the companies announced that they had signed a settlement and licensing agreement. As part of the deal, both parties will withdraw the ongoing lawsuit and release each other from all legal claims related to the matter.

Importantly, Sun Pharma will now have a limited, non-exclusive license to certain U.S. patents held by Incyte, specifically covering the use of deuruxolitinib for non-cancer indications such as alopecia areata. The agreement does not cover hematology or oncology (cancer-related) uses of the drug.

In exchange, Sun will make an upfront payment to Incyte and continue to pay royalties on sales of the drug for the licensed uses until the relevant patents expire. The exact financial details of the agreement were not disclosed.

LEQSELVI is a branded version of deuruxolitinib, a type of drug known as a Janus kinase (JAK) inhibitor. It works by interfering with the immune system process that causes inflammation and attacks hair follicles in conditions like alopecia areata. Incyte's LEQSELVI received U.S. FDA approval in June 2023 for the treatment of adults with severe alopecia areata.

The drug represents a major advancement for people with this condition, especially those who previously had limited treatment options. Its commercial potential has attracted interest from several global pharmaceutical players, including Sun Pharma, which has been expanding its presence in dermatology and specialty care in the U.S. market.

The settlement allows Sun Pharma to legally market deuruxolitinib for select indications in the U.S. — a crucial step as it looks to grow its specialty drug portfolio in the world’s largest pharmaceutical market.

“This agreement reflects our strategy to build a strong presence in dermatology and immunology,” a senior official at Sun Pharma said. “Alopecia areata is an underserved area and we’re committed to providing effective solutions.”

Sun Pharma, headquartered in Mumbai, is India’s largest drugmaker and one of the leading generic pharmaceutical companies globally. It has a significant presence in the U.S., emerging markets, and specialty segments like dermatology and ophthalmology.

Incyte Corporation, based in Wilmington, Delaware, is a biopharmaceutical company focused on developing proprietary therapies for oncology and inflammatory conditions.

The resolution of the lawsuit is expected to pave the way for faster patient access to deuruxolitinib-based treatments under Sun Pharma’s brand in the U.S., particularly for non-cancer conditions.

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