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11 Nov 2024
Admin
News Article

Lupin Receives US FDA Tentative Approval for Raltegravir Tablets, USP

Overview

Global pharma major Lupin Limited (Lupin) announced that it has received tentative approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application for raltegravir tablets USP, 600 mg, to market a generic equivalent of Isentress HD tablets, 600 mg of Merck Sharp & Dohme LLC. Lupin is the exclusive first-to-file for this product and may be eligible to receive a 180-day exclusivity. This product will be manufactured at Lupin’s Nagpur facility in India.

Raltegravir Tablets: Indication

Raltegravir tablets USP, 600 mg are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients and in paediatric patients weighing at least 40 kg.

Annual Sale

Raltegravir tablets USP, 600 mg (RLD Isentress HD) had an estimated annual sale of USD 36 million in the US (IQVIA MAT September 2024).

About Lupin

Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets.
Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.

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