Lupin Gets USFDA Nod For Generic Jynarque, Bags 180-Day Market Exclusivity

Lupin Ltd. on Thursday said it has received approval from the US Food and Drug Administration for its abbreviated new drug application for tolvaptan tablets in strengths of 15–90 milligrams.

Tolvaptan is used to slow the decline of kidney function in adults at risk of developing autosomal dominant polycystic kidney disease, the company stated in a filing to the stock exchanges.

Lupin’s product is a bioequivalent of Jynarque, a drug marketed by Otsuka Pharmaceutical Co. Ltd. The company said it is the first to file for this generic and will enjoy 180 days of market exclusivity in the US. The tablets will be manufactured at Lupin’s Nagpur facility and are expected to be launched soon.

Tolvaptan tablets clocked estimated annual sales of $1.47 billion in the US in 2024, the company said, citing IQVIA data