Shares of pharma major Lupin gained over a percent on April 24 after it announced receiving approval from USFDA for its Abbreviated New Drug Application (ANDA) for Tolvaptan tablets, used to slow down kidney function decline.
In an exchange filing, the company said it is the exclusive first-to-file for the product and eligible for 180 days of generic exclusivity. The drug will be manufactured at the Lupin’s facility in Nagpur and will be launched soon.
Tolvaptan slows down the deterioration of kidney function in adults who are at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). In its exchange filing, Lupin said the tablets had an annual sale of nearly $1.47 billion in US in 2024.
"We are very pleased to have obtained approval for generic Tolvaptan from the USFDA. This marks a significant entry into the nephrology segment and demonstrates our commitment to addressing the unmet needs of patients globally," said Lupin CEO Vinita Gupta.
Tolvaptan tablets is a bioequivalent of Jynarque, developed by Otsuka Pharmaceutical, and is used to treat autosomal dominant polycystic kidney disease (ADPKD), a chronic condition with limited treatment options.
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Lupin shares have so far surged over 8 percent in the past five days, however, the stock has dropped marginally in the past month and is lower by nearly 11 percent so far in 2025.
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