Lupin receives US FDA approval for generic Tolvaptan Tablets
Company secures 180-day marketing exclusivity as first-to-file applicant for bioequivalent to Jynarque
Lupin has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Tolvaptan Tablets in strengths of 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg. The approved product is bioequivalent to Jynarque Tablets of the same strengths, originally developed by Otsuka Pharmaceutical Company
Lupin is the exclusive first-to-file applicant for this product, making it eligible for 180 days of generic drug exclusivity in the United States. The company has confirmed that the manufacturing of Tolvaptan Tablets will take place at its facility located in Nagpur, India. Commercial launch in the U.S. market is expected soon.
Tolvaptan is indicated to slow the decline of kidney function in adults who are at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).
Vinita Gupta, Chief Executive Officer of Lupin, stated, “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.”
According to industry estimates, Tolvaptan Tablets (Reference Listed Drug: Jynarque) recorded annual sales of approximately USD 1,467 million in the U.S. for the fiscal year ending December 31, 2024.