US court clears Sun Pharma to launch Leqselvi for alopecia areata treatment

Sun Pharma is now preparing to launch the drug in US markets after facing legal issues since November 2024

Sun Pharmaceuticals Industries Ltd has received a favourable ruling from the US Court of Appeals for the Federal Circuit, which has lifted the preliminary injunction that had delayed the launch of its drug Leqselvi (deuruxolitinib) in the country. The ruling, effective immediately, allows the company to proceed with its launch plans, although legal proceedings with Incyte Corporation remain ongoing.

 

In an exchange filing, Sun Pharma stated, “On 9 April 2025, the US Court of Appeals for the Federal Circuit conducted an oral argument regarding the company’s appeal against the preliminary injunction imposed by the US District Court for the District of New Jersey. Shortly after the hearing, the appellate court ruled in our favour, vacating the injunction with immediate effect. While the litigation with Incyte Corporation continues, the injunction no longer restricts our ability to launch Leqselvi.”

 

What is Leqselvi?

Leqselvi is a medicine used to treat severe alopecia areata, manufactured by Sun Pharmaceutical. The generic name of the drug is deuruxolitinib. Alopecia areata is a condition where the body’s immune system attacks hair follicles, causing patchy hair loss on the scalp and sometimes other areas.

 

The medicine was approved by the US Food and Drug Administration (FDA) in July 2024 for the treatment of adults, but was not launched in US markets due to legal issues.

 

The medicine works by blocking certain enzymes (called JAK1 and JAK2) that calm down the immune system. This helps stop hair loss and encourages regrowth. However, because it affects the immune system, it can also increase the risk of several health conditions, therefore, doctors must prescribe it with caution. Leqselvi is not available in the market yet due to legal issues.  ALSO READ | Q4 results today: TCS and two others to kick off earnings season on Apr 10

 

What was the dispute?

The legal battle began on  August 1, 2024, when Sun Pharma disclosed that a motion had been filed in a US court seeking to prevent the launch of Leqselvi. On November 1, 2024, the US District Court of New Jersey ruled in favour of the injunction, delaying the drug’s release pending further legal developments or the expiry of the patent in question. Sun Pharma appealed this decision.

 

Following this latest ruling from the Court of Appeals, Sun Pharma is now free to proceed with the drug’s introduction to the US market. The company has assured stakeholders that it will announce its launch plans for Leqselvi in due course.

 

Sun Pharma’s shares ended Wednesday’s trading session down by 2.17 per cent, closing at ₹1,651.75 per share. The stock has experienced a 12.6 per cent decline so far in 2025. Markets are closed today for the occasion of Mahavir Jayanti.