Sun Pharma’s hair loss drug Leqselvi faces uncertain road to launch

The launch timeline of Sun Pharma's specialty drug Leqselvi (deuruxolitinib) continues to be stuck in a limbo even after two quarters since it got embroiled in a patent dispute. The drug, used for curing alopecia areata that causes hair loss, faced a legal setback in August 2024, just a week after receiving approval from the US Food and Drug Administration (FDA).

The latest legal development came in November 2024, when the US District Court of New Jersey issued a preliminary injunction, barring Sun Pharma from launching Leqselvi until further legal proceedings or the expiry of the contested patent in December 2026.

In its Q3 post-earnings call, Sun Pharma’s management offered conservative remarks on the drug’s launch timeline. The company stated that Leqselvi’s rollout hinges on a favourable court ruling, with oral arguments expected by April. However, it also acknowledged the possibility of waiting until the patent expires in December 2026 if a favourable judgement is not secured earlier.

Originally expected to generate $200 million in sales over the next three to four years, Leqselvi was slated for a July-August 2024 launch. However, US-based pharma firm Incyte filed a preliminary injunction alleging patent infringement, throwing a wrench into Sun Pharma’s plans.