Shares of Lupin Ltd were trading in the green and 2% higher on Thursday, 24 April, after the company announced that USFDA (US Food and Drug Administration) had approved its Abbreviated New Drug Application (ANDA) for Tolvaptan tablets, which are intended to delay the deterioration of kidney function.

In an exchange filing, the company stated that it was the first to file for the product, providing it with 180 days of generic exclusivity. The medication is currently being produced at Lupin’s Nagpur facility and will be available shortly.

Tolvaptan delays the decline of kidney function in people suffering from rapidly progressive autosomal dominant polycystic kidney disease (ADPKD). According to Lupin’s exchange report, tablet sales in the United States will be over $1.47 billion by 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.

Otsuka Pharmaceutical developed Tolvaptan tablets, a bioequivalent of Jynarque, to treat autosomal dominant polycystic kidney disease (ADPKD), a chronic condition with few therapies.

At 2:39 pm, the shares of Lupin Ltd were trading 0.69% higher at Rs 2,104 on NSE. 

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