Mumbai— Sun Pharmaceutical Industries announced Thursday that it has received a significant legal victory in the United States, paving the way for the launch of its new autoimmune disorder drug, Leqselvi (deuruxolitinib), in the U.S. market.
The U.S. Court of Appeals for the Federal Circuit ruled in favor of Sun Pharma, overturning a previous order that had blocked the company from launching Leqselvi. The drug is designed to treat an autoimmune condition that causes patchy hair loss.
The appellate court vacated a preliminary injunction that had been issued by a lower court in New Jersey, effectively removing any legal barriers to the drug’s release.
The dispute centers on a patent litigation case between Sun Pharma and Incyte Corporation, which had initially succeeded in obtaining a court order delaying Leqselvi’s launch due to alleged patent infringement involving the active compound, deuruxolitinib.
Sun Pharma appealed the lower court’s decision, and on April 9, 2025, the Federal Circuit Court heard oral arguments from both parties. Shortly after the hearing, the court ruled in Sun Pharma’s favor.
“Sun Pharma had been engaged in a patent infringement lawsuit with Incyte Corporation over LEQSELVI (deuruxolitinib),” the company stated in a regulatory filing. “On April 9, the U.S. Court of Appeals for the Federal Circuit held oral arguments regarding the appeal of the preliminary injunction issued by the U.S. District Court for the District of New Jersey. The court has now vacated that injunction.”
While the broader legal battle between the two pharmaceutical companies remains ongoing, the court’s latest decision allows Sun Pharma to proceed with the launch of Leqselvi in the U.S. without any current legal impediments.
In its regulatory filing, Sun Pharma confirmed that it is no longer subject to any court orders preventing the launch of Leqselvi and added that it will announce its launch plans in the coming days. (Source: IANS)
