Pharma major Lupin Ltd on Tuesday said it has launched the generic version of Tolvaptan tablets used to slow kidney function decline in the US market, following the recent approval received from the country's health regulator. The company has launched Tolvaptan tablets of strengths 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg in the US, after receiving the approval from the US Food and Drug Administration ( USFDA).
"Lupin holds the exclusive first-to-file status for this product and will have 180-day generic drug exclusivity," Lupin said in a statement.
Tolvaptan tablets are bioequivalent to Jynarque Tablets, 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg, of Otsuka Pharmaceutical Company, Ltd, and are indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD), it added.
Lupin CEO Vinita Gupta said the launch of Tolvaptan Tablets in the US will provide ADPKD patients with increased access to high-quality treatment options.
"Lupin holds the exclusive first-to-file status for this product and will have 180-day generic drug exclusivity," Lupin said in a statement.
Tolvaptan tablets are bioequivalent to Jynarque Tablets, 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg, of Otsuka Pharmaceutical Company, Ltd, and are indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD), it added.
Lupin CEO Vinita Gupta said the launch of Tolvaptan Tablets in the US will provide ADPKD patients with increased access to high-quality treatment options.
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