Sun Pharma Clears Legal Hurdle for Alopecia Drug Launch, Intensifying Market Competition

Sun Pharma has secured a significant legal victory, paving the way for the U.S. launch of its alopecia treatment Leqselvi. This development marks a major shift in the competitive landscape for autoimmune medications, particularly those targeting alopecia areata.

Legal Battle Resolved

The U.S. Court of Appeals for the Federal Circuit ruled in favor of Sun Pharma on Wednesday, overturning a previous injunction that had blocked the launch of Leqselvi in the United States. This decision effectively removes all court-ordered restrictions on the drug's market debut, allowing Sun Pharma to proceed with its rollout plans.

The legal dispute originated from a patent infringement lawsuit filed by Incyte Corporation against Sun Pharma in 2024. Despite ongoing litigation, the lifting of the preliminary injunction enables Sun Pharma to move forward with Leqselvi's introduction to the U.S. market.

A Sun Pharma spokesperson expressed satisfaction with the outcome, stating, "We are pleased with this result and look forward to making this innovative treatment available for patients."

Leqselvi: A New Player in Alopecia Treatment

Leqselvi, also known by its generic name deuruxolitinib, received FDA approval in July 2024 for the treatment of severe alopecia areata in adults. The drug is a deuterated form of Incyte's Jakafi (ruxolitinib), designed to enhance pharmacokinetic properties by replacing hydrogen atoms with deuterium atoms.

Sun Pharma estimates that alopecia affects approximately 700,000 people in the United States, with 300,000 suffering from the severe form of the disease. Alopecia areata is an autoimmune condition that attacks hair follicles, resulting in patchy hair loss.

Market Implications and Competition

The entry of Leqselvi into the U.S. market is poised to intensify competition in the alopecia treatment space. Currently, the market includes Eli Lilly and Incyte's Olumiant, which became the first FDA-approved treatment for alopecia in 2022, and Pfizer's Litfulo, approved in 2023.

Olumiant has shown strong performance, with Eli Lilly reporting total sales of $957 million for 2024. Under their collaboration agreement, Lilly pays Incyte tiered, double-digit royalties on worldwide net sales of the drug.

Unlike Leqselvi and Olumiant, which are approved only for adult use, Pfizer's Litfulo is authorized for both adults and children over 12 years of age, potentially giving it a broader market reach.

As Sun Pharma prepares to enter this competitive landscape, the company has indicated that it will discuss its launch plans "in due course of time." The introduction of Leqselvi, potentially at a lower price point than existing treatments, could significantly impact market dynamics and patient access to alopecia medications.