A New Jersey district court has dealt a significant setback to Sun Pharma's plans to enter the alopecia areata market, granting Incyte's request for a preliminary injunction against the launch of Leqselvi (deuruxolitinib). The ruling, issued on November 1st, effectively prevents Sun Pharma from introducing their recently FDA-approved treatment until either a favorable court decision or patent expiration.
Patent Dispute Details
The legal challenge centers on Incyte's US patent No. 9,662,335, which covers claims related to deuterated forms of ruxolitinib. Incyte argues that deuruxolitinib, being a deuterated variant of ruxolitinib, infringes upon their intellectual property rights. Ruxolitinib has been a fundamental component of Incyte's portfolio for over two decades, marketed as Jakafi for hematological cancers and Opzelura for dermatological conditions.
Market Impact and Commercial Implications
The court decision has significantly impacted Sun Pharma's commercial strategy and market position. The company, which acquired the drug through its $576 million purchase of Concert Pharma, had projected annual sales of $200 million within three to four years. The news prompted a sharp decline in Sun Pharma's share price on the National Stock Exchange of India.
Treatment Landscape for Alopecia Areata
Leqselvi represents part of an emerging class of JAK inhibitors for alopecia areata, an autoimmune condition causing patchy hair loss. The treatment landscape includes Eli Lilly and Incyte's Olumiant (baricitinib), which made history in 2022 as the first approved systemic therapy for the condition, and Pfizer's Litfulo (ritlecitinib), approved in June 2023.
Clinical Context
Alopecia areata affects more than 700,000 people in the United States, representing a significant unmet medical need. While ruxolitinib has demonstrated efficacy in alopecia studies, its use has been limited by side effects at therapeutic doses. The deuterated form developed by Sun Pharma was designed to offer improved pharmacokinetic properties.
Legal Next Steps
Sun Pharma has expressed disagreement with the court's decision and announced immediate plans to appeal. The injunction will remain in effect until either a subsequent favorable court decision or the expiration of the patent in question, potentially affecting the competitive dynamics in the alopecia areata treatment market.
