The drug is bioequivalent to Jynarque® Tablets by Otsuka Pharmaceutical Company. Lupin is the exclusive first-to-file applicant for this product, making it eligible for 180 days of generic market exclusivity in the U.S. market. The product will be manufactured at Lupin’s Nagpur facility in India and is expected to launch soon.
Tolvaptan is used to treat hyponatremia (low sodium levels in the blood) in patients with heart failure or syndrome of inappropriate antidiuretic hormone (SIADH). It is also approved to slow the progression of kidney function decline in adults at risk of rapidly advancing autosomal dominant polycystic kidney disease (ADPKD).
The approved product has estimated annual sales of USD 1,467 million in the U.S. for the fiscal year ended 31 December 2024.
Vinita Gupta, CEO of Lupin, said,““We are very pleased to have obtained approval for generic Tolvaptan from the U.S. FDA. This marks a significant entry into the nephrology segment and demonstrates our commitment to addressing the unmet needs of patients globally.”
Mumbai-based Lupin is an innovation-led, transnational pharmaceutical company. It develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.
Lupin’s consolidated net profit jumped 38.81% to Rs 858.86 crore on a 10.60% increase in sales to Rs 5,618.6 crore in Q3 FY25 compared to Q3 FY24.