Sun Pharma launches alopecia drug Leqselvi in US after settling patent dispute
Leqselvi (oral deuruxolitinib) is indicated for treatment of adults with severe alopecia areata.
Under the terms of settlement and licensing agreement, the two companies will seek a dismissal of the pending litigation in the United States District Court for the District of New Jersey, the company said in a release.
Sun and Incyte will mutually release each other of all claims that were raised or could have been raised in that litigation. Incyte has also granted a limited, non-exclusive licence to Sun to US patents no. 9,662,335 and other related patents. This licence covers oral deuruxolitinib for certain agreed-upon non-hematology-oncology indications including alopecia areata, the company said.
In return, Sun will pay Incyte an upfront amount, as well as ongoing royalty payments until expiry of the patents.
The company did not reveal other specific terms of the settlement.
In April 2025, Sun Pharma received a favourable ruling from the US Court of Appeals for the Federal Circuit, which vacated a preliminary injunction on Leqselvi's launch, lifting restrictions on the launch.
Sun received approval from the US Food and Drug Administration for Leqselvi in July 2024. Soon after the regulator's approval, Incyte Corporation filed a patent infringement lawsuit against Sun Pharma, alleging that Leqselvi infringed upon its existing patents, delaying the launch.
In November 2024, the US District Court of New Jersey granted a preliminary injunction, halting Leqselvi's launch in the US until the lawsuit was resolved.
Sun Pharma on Monday announced the launch of Leqselvi in the US, in a separate release. The drug will be available for prescription in 8mg tablets in the country.
'As a company committed to launching new therapeutic options which address the unmet needs of patients, adding LEQSELVI to our dermatology portfolio represents a key milestone for the business and an important advancement for the alopecia areata community," said Richard Ascroft, CEO, Sun Pharma North America, in the release.
Leqselvi demonstrated rapid results in clinical trials with one third of patients regaining almost all of their hair by week 24. Some patients (3%) achieved 80% or more scalp coverage as fast as 8 weeks.
Leqselvi is expected to be a $200 million opportunity for Sun Pharma in 3-4 years after launch, according to brokerage Elara Capital.
Sun Pharma's shares ended 0.58% higher at ₹ 1,681.70 apiece on NSE on Monday.
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