On July 14, 2025, Sun Pharmaceutical Industries Ltd. (“Sun Pharma”), a generic drug manufacturer based in Bombay, India, announced the settlement of a patent infringement lawsuit with US-based biopharmaceutical corporation Incyte Corporation (“Incyte”) related to its hair loss drug LEQSELVI and the subsequent launch of that drug in the United States for the treatment of adults with severe alopecia areata.

The announcement was made just a little over a year after Incyte filed a patent infringement lawsuit against Sun Pharma before the U.S. District Court for the District of New Jersey. Incyte claimed that LEQSELVI infringed several of its patents, most notably U.S. Patent No. 9,662,335, titled “Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as janus kinase inhibitors.”

          As part of the settlement, both parties have agreed to dismiss the lawsuit and mutually release each other of all past and future claims in relation to the dispute. Additionally, Sun Pharma has secured a non-exclusive license from Incyte under U.S. Patent No. 9,662,335 and certain other related patents to use deuruxolitinib, the active ingredient in LEQSELVI, for certain indications, including most notably the treatment of alopecia areata in adults.

          With the legal barriers now removed, Sun Pharma was able to move forward with the commercial launch of LEQSELVI in the United States. The drug offers a promising new option for adults affected by severe hair loss due to alopecia areata. In clinical trials, one-third of patients regained nearly all of their hair within just six months of treatment.

Sources:

1.      About Us | Sun Pharmaceutical Industries Limited (accessed on July 27, 2025);

2.      INCYTE CORPORATION et al v. SUN PHARMACEUTICAL INDUSTRIES LTD. et al 2:2024cv06944 | U.S. District Court for the District of New Jersey | Justia (accessed on July 27, 2025);

3.      Press-Release-Intimation-of-settlement-with-Incyte-Corporation-relating-to-LEQSELVI.pdf (accessed on July 27, 2025);

AFD_LEQSELVI-Product-Launch-Press-Release_7.14.25.pdf (accessed on July 27, 2025).