Mumbai, May 8 -- Raltegravir Tablets are bioequivalent to Isentress HD Tablets, 600 mg, of Merck Sharp & Dohme LLC. Lupin is the exclusive first-to-file for this product and is eligible for 180 days of generic drug exclusivity. The product will be manufactured at Lupin's Nagpur facility in India.
Raltegravir Tablets USP, 600 mg, are indicated for use in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult patients and pediatric patients weighing at least 40 kg.
Raltegravir Tablets USP, 600 mg (Reference Listed Drug: Isentress HD), had estimated annual sales of $34 million in the U.S. for the 12 months ending March 2025, according to IQVIA.
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