Sun Pharma can launch alopecia drug Leqselvi in US as court removes injunction
Sun Pharmaceutical Industries Ltd, which has been embroiled in a patent lawsuit in the US since last year over its specialty drug Leqselvi, received a favourable ruling from a court, paving the way for the drug’s launch in America, it said on Thursday.
The US Court of Appeals for the Federal Circuit on 9 April vacated a preliminary injunction on Leqselvi’s launch, lifting restrictions on the launch, Sun Pharma company said in a regulatory filing.
The Mumbai-based company had received approval from the US Food and Drug Administration for Leqselvi, a drug used to treat alopecia areata that causes hair loss or baldness, in July 2024.
However, soon after the regulator’s approval, American biopharma company Incyte Corporation filed a patent infringement lawsuit against Sun Pharma, alleging that Leqselvi infringed upon its existing patents.
In November 2024, the US District Court of New Jersey granted a preliminary injunction, halting Leqselvi’s launch in the US until the lawsuit was resolved.
While the injunction has been vacated, the broader patent litigation between Sun Pharma and Incyte Corporation is still ongoing. However, this ruling allows Sun Pharma to proceed with the launch of Leqselvi in the US.
“The company is no longer under a court order that delays or restricts the company from launching Leqselvi. The company will disclose Leqselvi launch plans in due course of time,” Sun Pharma said in the filing.
Cautious stance
Uncertainty over the launch had caused the company’s stocks to dip in November, and brokerages have remained cautious in their stance. The company had stated in previous earnings calls that if the rulings were unfavourable, it would have to wait until the patent expires in December 2026 to launch the drug.
“… my understanding is that this patent is valid till December of 2026. So in case if the judgment is what you call not in our favour, and if we can’t get a final judgment earlier than that, then we have to wait till December ’26,” Dilip Shanghvi, chairman and managing director of Sun Pharma, had said in an investor call in February.
Leqselvi is expected to be a $200 million opportunity for Sun Pharma in 3-4 years after launch, according to Elara Capital, a brokerage.
