BRIEF—Sun Pharma to appeal as injunction prevents US Leqselvi launch

6 November 2024

India’s Sun Pharma has been blocked in its efforts to launch its JAK inhibitor Leqselvi (deuruxolitinib) in the USA.

The product was approved to treat severe alopecia areata by the US Food and Drug Administration (FDA) in July of this year, and Sun had hoped to launch it in mid-October.

But US biotech Incyte launched legal action to prevent Leqselvi from being launched, claiming that it infringes the intellectual property protecting its own Eli Lilly-partnered  product Olumiant (baricitinib), which is also a JAK inhibitor approved for alopecia areata, along with Pfizer’s Litfulo (ritlecitinib).

The US District Court of New Jersey decided on Friday to grant a preliminary injunction delaying the launch of Leqselvi. As a result of the court decision, Sun is stopped from launching the drug until a subsequent favorable court decision or until the expiry of patent in lawsuit, whichever is earlier. 

A Sun statement on the matter reads: “We respectfully disagree with and intend to immediately appeal this decision.”

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