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

Sun Pharma's Leqselvi was originally expected to be a $200 million opportunity for Sun Pharma.

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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.

Uncertainty over Leqselvi's launch emerged as one of the biggest pain points for brokerages in the previous quarters, prompting many to lower their estimates for Sun Pharma to account for the delayed rollout.

Last quarter, brokerage firm Nomura had also pointed that concerns about Sun Pharma's specialty business may grow particularly if Leqselvi's revenue growth is slow.

Another firm, Nuvama Institutional Equities flagged concerns over a costly or delayed settlement in the patent infringement case, cautioning that it could erode Leqselvi’s net present value (NPV).

Disclaimer: The views and investment tips expressed by investment experts on Moneycontrol.com are their own and not those of the website or its management. Moneycontrol.com advises users to check with certified experts before taking any investment decisions.