Lupin Gets US FDA Approval for Tolvaptan Tablets for Hyponatremia

Global pharma major Lupin Limited (Lupin) announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application for tolvaptan tablets, 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg. Tolvaptan tablets are bioequivalent to Jynarque tablets, 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg, of Otsuka Pharmaceutical Company, Ltd. Lupin is the exclusive first-to-file for this product and is eligible for 180 days of generic drug exclusivity. This product will be manufactured at Lupin’s Nagpur facility in India and will be launched soon.
 
Tolvaptan is indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).
 
“We are very pleased to have obtained approval for generic tolvaptan from the US FDA. This marks a significant entry into the nephrology segment and demonstrates our commitment to addressing the unmet needs of patients globally,” said Vinita Gupta, CEO, Lupin.
 
Tolvaptan tablets (Jynarque) had an estimated annual sale of USD 1,467 million in the US (fiscal year ended December 31, 2024).
 
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.

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