Lupin receives tentative U.S. FDA approval for Raltegravir tablets

Lupin, a global pharmaceutical company, has announced its tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Raltegravir Tablets USP, 600 mg. The approval enables Lupin to market a generic equivalent of Isentress HD Tablets, 600 mg, produced by Merck Sharp & Dohme LLC. Lupin is the exclusive first-to-file applicant for this product, potentially granting it a 180-day exclusivity period in the U.S. market. Lupin’s Nagpur facility in India will be responsible for manufacturing the product.

Raltegravir Tablets USP, 600 mg, when combined with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients and paediatric patients weighing at least 40 kg. This medication targets the virus, aiming to lower viral load and improve immune function in affected individuals.

The reference-listed drug, Raltegravir Tablets USP, 600 mg (RLD Isentress HD), generated estimated annual sales of USD 36 million in the U.S., according to IQVIA data for the 12 months ending September 2024. Lupin’s entry with a generic option may influence the market dynamics for this antiretroviral treatment.