Sun Pharma has received a favourable ruling from the US Court of Appeals for the Federal Circuit, which has vacated the preliminary injunction effective immediately, paving way for the launch of Leqselvi in America, a company filing said on April 10.
"While the litigation between Incyte Corporation and the Company continues, the preliminary injunction is no longer in effect," the statement by Sun Pharma said.
Why it Matters
Sun Pharma had appealed against the District of New Jersey’s decision that had previously granted a preliminary injunction delaying its launch of Leqselvi (deuruxolitinib) in the United States. The pharma company said it will disclose its launch plans in due course of time, and it is no longer under the court order that delays or restricts Leqselvi in America.
Dilip Shanghvi had said in February that the judgment was crucial for Sun Pharma's future course of action on this drug launch. "...the judgment is to validate the existing judgment, and we can't launch till the time we get a more favourable judgment."
According to market estimates, Leqselvi is projected to contribute $90 million to Sun Pharma's sales in FY26, and $125 million in FY27.
Case Background
Sun Pharma early last year took a big leap when it acquired the drug Leqselvi through its $576 million Concert Pharma buyout in March 2023, and had positioned the drug as a key product in its specialty portfolio.
The deal gave Sun Pharma rights to its lead candidate deuruxolitinib, a drug that is being portrayed as a “potential best-in-class” drug.
Incyte Corporation had filed a patent infringement suit against Sun Pharma, which claimed that the drug is an infringement on one of its patent for ruxolitinib, a similar drug, and valid until December 2026. Subsequently, the US District Court of New Jersey had in November 2024 granted Incyte a preliminary injunction, which prevented Sun Pharma from rolling out Leqselvi in US until a favourable hearing, or the expiry of the patent, ie, December 2026.
What is Leqselvi
Leqselvi, or deuruxolitinib, is a drug approved by the USFDA to treat alopecia areata, an autoimmune condition that causes hair loss. The drug was approved by USFDA last year. Sun Pharma has a five-year marketing exclusivity for the product and there are no pending queries from the USFDA for the product.
The disease affects up to 2.5% of the US population, and there are currently limited treatment options available for alopecia areata.
Sun Pharma's Specialty Business
Sun Pharma's global specialty business, of which majority of the sales comes from US, has surpassed $1 billion sales milestone in FY24. Global specialty sales, that contributed about 18% of Sun Pharma revenue, grew 19% YoY to $ 1.04 billion in FY24.
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