Sun Pharma’s hair loss drug in the cross hairs in US, Health News, ET HealthWorld

Mumbai: Sun Pharma’s much anticipated US commercial launch of its specialty product Leqselvi (deuruxolitinib) is facing uncertainty due to a patent dispute.

Leqselvi is used for the treatment of alopecia areata, an autoimmune disease that leads to hair loss, and was approved by the US Food and Drug Administration (USFDA) last week. Sun Pharma has been making preparations for months to launch the drug in July, but an injunction motion by the American drugmaker lncyte Corporation in the US District Court for the District of New Jersey has put the brakes on the launch.

Incyte in its injunction motion alleged that Sun Pharma’s pre-launch activities and its immediate post-approval commercial market launch plans have violated Incyte’s rightful intellectual property in the valid and enforceable ‘335 Patent’ covering deuterated ruxolitinib analogs.

“The imminent or ongoing infringement by Sun will cause irreparable harm and drastically devalue Incyte’s related investments, including investments made into Jakafi (ruxolitinib) and multiple other products,” the injunction motion said.

In August last year, the United States Court of Appeals for the Federal Circuit upheld a previous ruling by the Patent Trial and Appeal Board (PTAB) that invalidated US patent 149, which covered the deuruxolitinib compound.

“Currently, a patent infringement action and a motion seeking a preliminary injunction have been filed by lncyte,” Sun Pharma said.

The company said it intends to “rigorously oppose” the motion and patent infringement action. “The decision of the Leqselvi launch will be governed by the decision of the court on the motion,” it said.

The company added that it is working towards an early outcome.

“I think specially in the context of the US, either a favourable judgement or settlement will remain an option,” said Dilip Shanghvi, managing director of Sun Pharma.

Early last year, Sun Pharma took a big leap with the acquisition of US-based Concert Pharma. Sun Pharma said it will be paying $576 million (₹4,600 crore) upfront, added with conditional sales-based milestone payments, for the acquisition. The deal gave Sun Pharma rights to its lead candidate deuruxolitinib, a drug that is being portrayed as a “potential best-in-class” drug.

Sun Pharma has a five-year marketing exclusivity for the product and there are no pending queries from the USFDA for the product.

Sun Pharma’s global specialty business of which the majority of sales come from the US has surpassed the $1 billion sales milestone in FY24. Global specialty sales contributed about 18% of Sun Pharma’s revenue which grew 19% YoY to $ 1.04 billion in FY24.