Lupin Ltd announced on Tuesday the launch of its generic version of Tolvaptan tablets in the US, a drug used to slow the progression of kidney function decline. The launch follows recent approval from the US Food and Drug Administration (USFDA).
The company has introduced Tolvaptan tablets in multiple strengths—15 mg, 30 mg, 45 mg, 60 mg, and 90 mg—in the US market.
In an official statement, Lupin confirmed that it holds the exclusive first-to-file status for this product, granting it 180 days of marketing exclusivity for the generic version.