Global pharma major Lupin Ltd on Tuesday (November 3) announced the launch of Raltegravir Tablets USP, 600 mg, in the United States following approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA).
The company, which is the exclusive first-to-file for the product, is eligible for 180-day generic drug exclusivity.
Raltegravir Tablets USP, 600 mg, are bioequivalent to the reference listed drug (RLD), Isentress HD Tablets, 600 mg, marketed by Merck Sharp & Dohme LLC.
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The drug is indicated in combination with other antiretroviral agents for the treatment of Human Immunodeficiency Virus (HIV-1) infection in adults and paediatric patients weighing at least 40 kg.
According to IQVIA MAT September 2026 data, Raltegravir Tablets USP, 600 mg, had estimated annual sales of $26 million in the US.
Yesterday, Lupin received approval from the United States Food and Drug Administration (USFDA) for its Amifampridine Tablets, 10 mg, and is eligible for 180 days of shared generic exclusivity as one of the first applicants to file for the drug.
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The approval was granted for the company’s Abbreviated New Drug Application (ANDA) for Amifampridine Tablets, 10 mg, which are bioequivalent to the reference listed drug (RLD), Firdapse Tablets, 10 mg, marketed by Catalyst Pharmaceuticals Inc.
The tablets are approved for the indication specified in the approved labelling, the company said.
Shares of Lupin Ltd ended at ₹2,012.00, up by ₹15.45, or 0.77%, on the BSE.