Lupin Ltd said it has launched Tolvaptan tablets in the US in strengths of 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg with 180-day marketing exclusivity.

Tolvaptan is prescribed to treat low sodium levels in patients with heart failure or syndrome of inappropriate antidiuretic hormone, and also helps slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease.

The launch follows US Food and Drug Administration’s approval for the product on April 24, the company said in a filing.
Lupin said its Tolvaptan tablets are bioequivalent to Jynarque tablets of Otsuka Pharmaceutical Co. Ltd. The 180-day exclusivity means no other generics can enter the market during this period.

Tolvaptan tablets had estimated annual sales of $1.48 billion in the US in the year ended December, the company said.