logo

Sun Pharma Launches Leqselvi in U.S. After Settling Patent Dispute with Incyte


Key Points :

Sun Pharma brings Leqselvi to US market after resolving patent war with Incyte Corp.

Medicine is for the treatment of extensive alopecia areata and can cross USD 400 million mark by 2030.

Key Background :

Sun Pharma, the largest drugmaker in India, received FDA approval for Leqselvi in July 2024. Leqselvi treats advanced alopecia areata, a condition where the immune system of the body targets the hair follicles and results in extensive loss of hair, which is predominantly on the scalp and in part on the entire body. There are few effective treatments for this disease, and therefore the approval of deuruxolitinib is a big step in the dermatology industry.

But the American launch of the product was thwarted when Incyte Corporation alleged patent infringement, stating that Leqselvi had violated its already patented intellectual property in ruxolitinib, another JAK inhibitor product. In November 2024, an American court granted a preliminary injunction halting the launch of the Sun Pharma product. The injunction remained until April 2025 when an appellate court ruling in their favor created the possibility of launch.

Subsequently, the two firms agreed to settle the issue out of court. According to the settlement deal, Sun Pharma was awarded a limited patent license by Incyte so that it can sell deuruxolitinib in the US for alopecia areata and other non-oncology conditions. Upfront and royalty fees must be paid by Sun Pharma, but not the amounts.

Sun Pharma North America President and CEO Richard Ascroft placed special significance on this achievement, pointing out that Leqselvi brings substantial value to the specialty portfolio of the firm and brings promise to new patients. He also pointed out that demand for targeted dermatologic therapies is increasing in the United States and the firm is well-positioned to take advantage.

Market analysts were quick to react. A number of institutions project that the product can gain strong adoption, considering the low level of competition and high demand for effective solutions against alopecia. The potential revenue of Leqselvi is projected to reach USD 400 million by FY2030, with some optimistic estimates putting it around USD 900 million in the longer term. Initial estimates by investment banks cover FY26 sales of USD 61 million and USD 83 million in FY27.

The shareholders took the news positively, and Sun Pharma's shares increased shortly thereafter. Market analysts are convinced that the move will be a massive shot in the arm to Sun's market share in the U.S. pharma segment, and especially specialty and dermatology sectors.