Sun Pharma’s Leqselvi Faces Legal Obstacles in US Launch Despite FDA Approval

Sun Pharmaceutical Industries Ltd’s new alopecia treatment, Leqselvi (Deuruxolitinib), recently approved by the US Food and Drug Administration (FDA), is encountering legal challenges that may delay its market debut. A motion for a preliminary injunction has been filed in a US court to block the drug’s launch, putting the company’s planned rollout on hold.

Due to these ongoing legal proceedings, Sun Pharma is unable to provide a timeline for when Leqselvi might become available in the US. The company’s management remains cautious as the legal situation unfolds.

Despite this setback, Sun Pharma reported positive financial performance in other areas. The company’s branded generics segment in the US grew by 11%, while global specialty sales totaled $266 million for the quarter, compared to $271 million the previous quarter.

Investment in research and development remains a key focus for Sun Pharma. The company allocates 45% of its R&D expenditure to specialty drugs and anticipates a rise in R&D costs as it moves towards its goal of investing 8 to 10% of sales in R&D.

Additionally, Sun Pharma has completed the acquisition of its US subsidiary, Taro, which is now fully integrated and delisted from US stock exchanges. Efforts to streamline operations and leverage synergies between Sun Pharma and Taro are underway.

Sun Pharma is also preparing to request a re-audit of its Halol manufacturing plant, which has been under an import alert since 2022. The company will seek this re-audit only when it is confident in its compliance and readiness for inspection.