Sun Pharma alopecia drug Leqselvi launch blocked in US
New Delhi: Pharma giant, Sun Pharmaceutical’s launch of its specialty drug Leqselvi in the U.S. market is in limbo as the U.S. District Court in New Jersey has issued a preliminary injunction. The drug, which recently gained approval to treat severe alopecia areata, is now on hold pending further legal developments.
Sun Pharma has announced plans to appeal the decision while complying with the injunction.
On November 1, 2024, the U.S. District Court in New Jersey issued a preliminary injunction against Sun Pharma, preventing the launch of its drug LEQSELVI due to a patent infringement suit filed by Incyte Corporation.
Prior to this, in October, Sun Pharma had presented new data highlighting the clinical efficacy and safety of LEQSELVI (deuruxolitinib) 8 mg tablets at the 44th Annual Fall Clinical Dermatology Conference, held October 24-27, 2024, in Las Vegas, Nevada.
LEQSELVI (deuruxolitinib) 8 mg tablets received FDA approval on July 25, 2024, for treating severe alopecia areata in adults.
Also Read: Sun Pharma gets USFDA nod for alopecia areata drug Leqselvi
However, Incyte Corporation and Incyte Holdings Corporation subsequently filed a patent infringement lawsuit, along with a motion for a preliminary injunction, in the New Jersey District Court to block the launch.
In response to the injunction motion filed by Incyte on August 1, 2024, Sun Pharma expressed its opposition and confirmed plans to challenge the court’s recent decision.
The injunction halts Sun Pharma’s plans to release LEQSELVI until a favorable court ruling or the expiration of the contested patent. “We respectfully disagree with the decision and intend to file an immediate appeal,” Sun Pharma stated in a public filing.
Despite this setback, Sun Pharma’s Q2FY25 consolidated financials demonstrated solid growth across multiple segments. The company announced a 28% year-over-year increase in net profit for Q2FY25, reporting Rs. 30,402 million. It further reported a 10.5% year-on-year rise in gross sales, amounting to Rs. 132,642 million, with U.S. formulation sales increasing by 20.3% to $517 million. Specialty sales reached $286 million, up 19.2%, reflecting strong demand across its existing U.S. portfolio.
