Lupin Secures USFDA Nod for Tolvaptan: A Milestone in Nephrology

Pharma giant Lupin Ltd received USFDA approval for its generic version of Tolvaptan, used for a kidney disease. With this, Lupin gets exclusive marketing for 180 days and plans to launch soon, marking its entry into nephrology. Tolvaptan sales are projected at $1,467 million in 2024.

Lupin Ltd, a leading pharmaceutical company, has secured the approval of the US Food and Drug Administration for its generic Tolvaptan tablets, used to treat a specific type of kidney disease. This approval signifies a critical advancement for the company's venture into the nephrology sector.

The FDA's nod covers various strengths: 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg, positioning these as bioequivalent to Otsuka Pharmaceutical's Jynarque tablets. As the exclusive first-to-file, Lupin is poised for 180 days of market exclusivity, a promising opportunity for the company's market expansion.

The Tolvaptan tablets will be manufactured at Lupin's Nagpur facility, with plans for a prompt launch. Receiving this approval, Lupin CEO Vinita Gupta emphasized the company's commitment to addressing unmet patient needs. The tablets are anticipated to reach an annual sale of $1,467 million in the US by 2024.

(With inputs from agencies.)