Sun Pharma settles patent litigation with Incyte, paving way for launch of anti-baldness drug LEQSELVI

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26 Aug, 2025 12:21

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India's largest pharmaceutical company, Sun Pharma announced on July 14 that it has settled a patent litigation with US biopharma MNC Incyte Corporation for an upfront payment over and above an ongoing royalty, paving the way for an immediate US launch of LEQSELVI (deuruxolitinib), used to treat severe alopecia areata, an autoimmune disease that leads to hair loss or baldness.

The agreement stipulates that both parties will seek dismissal of the pending LEQSELVI litigation in the US District Court for the District of New Jersey, and will mutually release all claims that were or could have been raised in the litigation.

As part of the agreement, Incyte has granted Sun Pharma a 'limited, non-exclusive license' to US Patent Nos. 9,662,335 and other related patents. This license pertains to oral deuruxolitinib for certain agreed-upon non-hematology-oncology indications, including alopecia areata, the statement said.

In exchange for the settlement and license, Sun Pharma will make an upfront payment to Incyte, in addition to ongoing royalty payments until the expiry of the patents. The specific financial terms of the settlement and license agreement remain confidential.

The launch of LEQSELVI has been delayed by a year due to patent litigation between Sun Pharma and Incyte. The American biopharma company had secured injunction against the proposed launch of the drug in July, claiming that Sun’s pre-launch activities have violated Incyte’s rightful intellectual property in the valid and enforceable ’335 Patent.

Sun Pharma had paid $576 million (Rs 4,600 crore) upfront, added with conditional sales-based milestone payments for the acquisition LEQSELVI from US-based Concert Pharma.

Richard Ascroft, CEO of Sun Pharma North America, stated that the launch provides an "effective, new treatment option" for eligible patients and healthcare providers, highlighting LEQSELVI as a 'key milestone' for the company's dermatology portfolio and an 'important advancement' for the alopecia areata community.

Sun Pharma said LEQSELVI demonstrated rapid results in clinical trials, with one-third of patients regaining almost all of their hair by week 24. Some patients achieved 80% or more scalp coverage as early as 8 weeks.

Alopecia areata can have significant psychosocial impact, leading to psychological distress and loss of self-confidence due to unpredictable hair loss. Nicole Friedland, President and CEO of the National Alopecia Areata Foundation (NAAF), expressed optimism, stating that LEQSELVI offers "hope" and expands choices for individuals seeking an FDA-approved treatment for this autoimmune disease.