Legal Victory Unleashes Sun Pharma’s Alopecia Wonder Drug in America

Sun Pharmaceutical Industries Ltd has achieved a significant legal victory, clearing the way for approval of its drug Leqselvi (deuruxolitinib) to treat alopecia in the United States. The US Federal Circuit Court of Appeals vacated a preliminary injunction granted by a New Jersey judge, in essence removing orders which had postponed the market launch since November 2024.

Top Points:

Court Judgment: On April 9, 2025, the court made a verdict in favor of Sun Pharma after conducting oral arguments and permitting the firm to proceed with its planned launches for Leqselvi on an immediate basis. Litigation against Incyte Corporation concerning allegations of patent infringement continues to endure.

About Leqselvi: FDA-approved in July 2024, Leqselvi is intended to treat severe alopecia areata, an autoimmune disorder leading to patchy hair loss. Leqselvi inhibits JAK1 and JAK2 enzymes to control immune responses and induce hair regrowth.

Market Potential: Alopecia areta impacts some 700,000 individuals in the US and another 300,000 experience serious cases of it. Entry into the market by Leqselvi finds it competing against existing treatments like Eli Lilly's Olumiant and Pfizer's Litfulo.

Next Steps: Sun Pharma aims to issue more detailed rollout strategies shortly and remained hopeful regarding getting this pioneering treatment to the patient.

This judgment is a milestone for Sun Pharma as it is poised to enter the highly profitable US autoimmune disease treatment market. The success of the company speaks volumes about its dedication to solving unmet medical needs despite facing complex legal issues.

Source: Business Standard, Fierce Pharma, Devdiscourse