Sun Pharmaceutical Industries Ltd has been involved in a U.S. patent lawsuit for its specialist drug Leqselvi since last year and has obtained a favorable ruling from the court, paving the way for the launch of a U.S. launch in the U.S.
Sun Pharma Company said in a regulatory filing that the U.S. Federal Circuit Court of Appeals on April 9 issued restrictions on the launch of Leqselvi.
The Mumbai-based company has received approval from the U.S. Food and Drug Administration (Leqselvi), a drug used to treat hair loss or baldness in July 2024.
But shortly after regulatory approval, U.S. biopharmaceutical company Incyte Corporation filed a patent infringement lawsuit against Sun Pharma, claiming that Leqselvi infringed its existing patent.
In November 2024, the U.S. District Court for New Jersey granted a preliminary injunction, halting the initiation of Leqselvi in ​​the United States until the lawsuit is resolved.
Even though the ban has been evacuated, a wider patent lawsuit between Sun Pharma and Incyte Corporation is still underway. However, the ruling allowed Sun Pharma to continue to launch Leqselvi in ​​the United States.
“The company no longer delays or restricts the company’s launch of Leqselvi in ​​accordance with court orders. The company will disclose the Leqselvi launch plan in due course,” Sun Pharma said in the filing.
A cautious position
The uncertainty of the issuance caused the company’s shares to fall in November, and the broker’s position remains cautious. In previous earnings calls, the company said it would wait until the patent expires in December 2026 before launching the drug if these rulings are unfavorable.
“…My understanding is that the patent is valid until December 2026.
Leqselvi is expected to provide Sun Pharma with $200 million in 3-4 years after launch, agency Elara Capital said.
