Mumbai– Sun Pharmaceutical Industries announced on Thursday that it has received a significant legal victory in the United States, allowing it to launch its new drug, Leqselvi (deuruxolitinib), in the U.S. market.
Leqselvi is used to treat an autoimmune disorder that causes patchy hair loss. The U.S. Court of Appeals for the Federal Circuit ruled in favor of Sun Pharma, lifting previous restrictions that had prevented the company from introducing the drug.
The court immediately vacated a preliminary injunction, enabling Sun Pharma to proceed with its U.S. launch plans.
The case centers around a patent dispute between Sun Pharma and Incyte Corporation. A lower court in New Jersey had earlier issued an injunction delaying the launch of Leqselvi, citing concerns over patent infringement related to the compound deuruxolitinib.
Sun Pharma appealed the decision to the U.S. Court of Appeals. On April 9, 2025, the court heard oral arguments and swiftly issued a ruling in Sun Pharma’s favor, effectively removing the injunction.
“Sun Pharma had been engaged in patent infringement litigation with Incyte Corporation over LEQSELVI (deuruxolitinib). On April 9, the U.S. Court of Appeals for the Federal Circuit heard oral arguments related to our appeal of the U.S. District Court for the District of New Jersey’s preliminary injunction, which had delayed the launch of Leqselvi in the U.S.,” the company said in a regulatory filing.
While the broader legal dispute between the two companies remains unresolved, the recent court decision clears the way for Sun Pharma to move forward with the drug’s launch—at least for now.
In its filing, Sun Pharma confirmed that it is no longer subject to any court order that delays or blocks the release of Leqselvi. The company added that it will announce its official launch plans for the drug in the coming days. (Source: IANS)
