Lupin secures US FDA approval for Tolvaptan tablets, eyeing nephrology market

Lupin Limited on Thursday said it received approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Tolvaptan tablets in 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg strengths.

Tolvaptan tabs are bioequivalent to Jynarque tablets from Otsuka Pharmaceutical Company. This approval positions Lupin as the exclusive first-to-file manufacturer, granting it 180 days of generic drug exclusivity. The tablets will be produced at Lupin’s Nagpur facility in India, with plans for a forthcoming launch.

Tolvaptan is used to manage kidney function decline in adults who are at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).

The US market for Tolvaptan tablets is significant, with estimated annual sales reaching $1,467 million as of the fiscal year ending December 31, 2024. This development is part of Lupin's strategy to strengthen its foothold in the nephrology sector, addressing a critical area of patient need.

Vinita Gupta, CEO of Lupin, expressed satisfaction with this regulatory milestone, stating: "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." Lupin's focus on expanding its product portfolio in targeted areas is evident in this strategic move.

The approval of Tolvaptan tablets further underscores Lupin's dedication to providing affordable healthcare solutions globally. With the manufacturing set in India, the company is poised to leverage its production capabilities while entering the lucrative US generic market.

This development is expected to have positive implications for Lupin's market position and its ongoing efforts to deliver high-quality, accessible medicines.

Lupin shares were last seen trading 0.78 per cent higher at Rs 2,105.10.