Lupin

Lupin Ltd has reached a settlement agreement worth USD 30 million (approximately Rs 250 crore) through its U.S. subsidiary Lupin Pharmaceuticals Inc with Humana Inc, resolving allegations tied to anti-competitive practices. The dispute was part of a broader, consolidated litigation framework in the United States involving multiple pharmaceutical firms. The settlement allows Lupin to mitigate legal uncertainties and refocus on its core business operations, while avoiding prolonged litigation risks in a complex regulatory environment.

Resolution of a Complex Legal Dispute

Lupin Ltd has received tentative approval from the US Food and Drug Administration for its generic version of Pitolisant tablets, used to treat excessive daytime sleepiness. The approval, granted under the abbreviated new drug application (ANDA) pathway, covers strengths of 4.45 mg and 17.8 mg. The product will be manufactured at Lupin’s Nagpur facility, reinforcing its global manufacturing footprint. This development highlights Lupin’s continued focus on expanding its central nervous system (CNS) portfolio while strengthening its presence in the highly regulated US generics market.