Lupin Ltd, a leading pharmaceutical company, has received approval from the US Food and Drug Administration (USFDA) for its generic version of Tolvaptan tablets. The tablets are indicated for the treatment of autosomal dominant polycystic kidney disease (ADPKD), a certain type of kidney disease. The approval is for Tolvaptan tablets in strengths of 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg, which are bioequivalent to Jynarque tablets manufactured by Otsuka Pharmaceutical Company Ltd.
Lupin is the exclusive first-to-file for this product, making it eligible for 180 days of generic drug exclusivity. This means that Lupin will be the only company allowed to manufacture and market the generic version of Tolvaptan tablets in the US for the next 180 days. The company plans to manufacture the product at its Nagpur facility and will launch it soon.
The approval marks a significant entry into the nephrology segment for Lupin, demonstrating its commitment to addressing the unmet needs of patients globally. Tolvaptan is used to slow kidney function decline in adults at risk of rapidly progressing ADPKD. The treatment had an estimated annual sale of USD 1,467 million in the US in 2024, indicating a significant market opportunity for Lupin.
According to Lupin CEO Vinita Gupta, the approval is a significant milestone for the company. “This marks a significant entry into the nephrology segment and demonstrates our commitment to addressing the unmet needs of patients globally,” she said. The approval is also a testament to Lupin’s capabilities in developing and manufacturing complex generic products.
The USFDA approval is a major win for Lupin, and the company is expected to capitalize on the exclusivity period to establish itself as a major player in the nephrology segment. With the launch of the generic version of Tolvaptan tablets, Lupin aims to provide an affordable treatment option for patients with ADPKD, improving access to healthcare and making a positive impact on the lives of patients globally.