After resolving a patent dispute with Incyte, Sun Pharma has officially launched its JAK inhibitor Leqselvi in the U.S.
Sun’s Leqselvi is now available for prescription to eligible patients with severe alopecia areata nationwide, the company announced on Monday. The drug is poised to compete with Pfizer’s rivaling Litfulo and Eli Lilly and Incyte’s first-to-market Olumiant.
“Adding Leqselvi to our dermatology portfolio represents a key milestone for the business and an important advancement for the alopecia areata community,” Sun’s CEO Richard Ascroft said in the company’s release.
The launch comes after a legal back-and-forth with Incyte has now ended in a settlement agreement.
While the specific terms of the settlement and license agreement are confidential, Incyte offered Sun a limited, non-exclusive license to certain patents for Leqselvi’s U.S. use in agreed-upon non-hematology/oncology indications, including alopecia areata. In exchange, Sun will pay Incyte an upfront plus royalty payments until the patents expire.
The two will “mutually release” each other of claims stemming from the litigation and are to seek dismissal of the pending lawsuit at a New Jersey U.S. District Court, Sun announced in a separate press release.
Incyte calls the agreement a “successful settlement” and a “positive outcome” that “aligns with Incyte’s long-term business objectives,” the company said in its own press release.
Incyte had come after Sun and its Leqselvi with a 2024 lawsuit claiming that the drug is structurally identical to its own blockbuster JAK inhibitor franchise ruxolitinib, which is marketed as oral Jakafi and topical Opzelura. The patent in question covers ruxolitinib’s use in immune-related diseases, skin disorders, myeloid proliferative disorders and cancer.
One main concern of Incyte’s suit was that Leqselvi would be sold at a lower price than Jakafi, potentially leading to off-label prescriptions of Sun’s cheaper option to treat indications covered by Incyte’s older offering. In its complaint, the company suggested that Leqselvi’s launch could prompt price erosion for Jakafi, lost licensing royalties from its Eli Lilly-partnered JAK inhibitor Olumiant in alopecia, layoffs and decreased R&D opportunities.
Sun, for its part, maintained that its product doesn’t infringe on Incyte’s patent and the off-label concerns were speculative.
Either way, Incyte’s lawsuit caused an injunction blocking Sun’s U.S. rollout, which was initially planned for October of last year after it snagged FDA approval in July. Leqselvi, or deuruxolitinib, is a deuterated form of ruxolitinib. Deuterated drugs replace hydrogen atoms with deuterium atoms to effectively boost a medicine’s pharmacokinetic properties.
Sun scored a win from the U.S. Court of Appeals in April, gaining a clearance for Leqselvi to launch in the U.S.
Leqselvi’s entrance in the alopecia market could signal a heated sales battle between Sun, Incyte and Pfizer. Pfizer’s Litfulo has the broadest label of the three, with an indication that covers both adults and adolescents, while the other two can only treat adults. Alopecia areata may impact up to 2.5% of the U.S. and global population during their lifetime, according to Sun.
Pfizer has not revealed Litfulo sales outcomes since its 2023 approval, but Lilly reported $957 million in Olumiant sales over 2024. Incyte receives tiered, double-digit royalties from its Lilly collaboration on the drug, which is also approved to treat COVID-19 and rheumatoid arthritis.