Sun Pharmaceutical Industries stock ended 2.15 per cent higher on Friday after zooming by almost 5 per cent in the morning trade on the back of an announcement that a court ruling has cleared the deck for the India’s largest pharmaceutical company to launch its alopecia drug Leqselvi in the United States.
Photograph: Francis Mascarenhas/Reuters
The US Court of Appeals for the Federal Circuit has paved the way for the launch of Leqselvi in the US, after almost a year of legal battle over the patent.
According to market estimates, Leqselvi is projected to contribute $90 million to Sun Pharma’s sales in the financial year 2026 (FY26), and $125 million in FY27.
Sun Pharma said it will disclose its launch plans in due course of time.
Leqselvi or deuruxolitinib is used to treat alopecia areata, an auto-immune condition that causes hair-loss, and it affects almost 2.5 per cent of the US population.
Sun Pharma has a five-year marketing exclusivity for the product.
The company on late Thursday night told BSE that the US Court of Appeals for the Federal Circuit has vacated the preliminary injunction on the release of the drug effective immediately.
“While the litigation between Incyte Corporation and the company continues, the preliminary injunction is no longer in effect,” the statement said.
The US court heard an oral argument on the company’s appeal against the US District Court for the District of New Jersey’s decision that previously granted a preliminary injunction delaying the company’s launch of Leqselvi (deuruxolitinib) in the US.
Shortly after the oral argument concluded, on April 9, 2025, the US Court of Appeals for the Federal Circuit ruled in favour of the company and vacated the preliminary injunction effective immediately, the company said.
Dilip Shanghvi, CMD, Sun Pharma had said earlier this year that the judgement was crucial for Sun Pharma’s future course of action on this drug launch.
The company has been focussing on its global specialty business off late, which in fact, insulates the company partially from tariff impositions, as it operates in a limited-competition area.
The specialty drug sales crossed $1billion in FY24.
Global Specialty sales, ex-milestone, accounted for 21 per cent of Q3FY25 sales.
The company has six more drugs apart from Leqselvi in the pipeline for global specialty launch, which are in various stages of clinical trials at the moment.
Sun Pharma had acquired Leqselvi through its Concert Pharma buyout in March 2023.
The deal gave Sun Pharma rights to Concert Pharma’s lead candidate deuruxolitinib.
Incyte Corporation had filed a patent infringement suit against Sun Pharma, which claimed that the drug is an infringement on one of its patents for ruxolitinib.
Incyte claimed that the patent was valid until December 2026, and following that US District Court of New Jersey had granted a preliminary injunction to Incyte in November last year.
This prevented Sun Pharma from rolling out Leqselvi in the US.
