Mumbai, April 24 -- The drug is bioequivalent to Jynarque(R) Tablets by Otsuka Pharmaceutical Company. Lupin is the exclusive first-to-file applicant for this product, making it eligible for 180 days of generic market exclusivity in the U.S. market. The product will be manufactured at Lupin's Nagpur facility in India and is expected to launch soon.

Tolvaptan is used to treat hyponatremia (low sodium levels in the blood) in patients with heart failure or syndrome of inappropriate antidiuretic hormone (SIADH). It is also approved to slow the progression of kidney function decline in adults at risk of rapidly advancing autosomal dominant polycystic kidney disease (ADPKD).

The approved product has estimated annual sales of USD 1,467 million...