Lupin Receives Tentative FDA Approval for Generic Raltegravir Tablets
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Lupin secured tentative FDA approval for its generic version of Raltegravir 600mg tablets, a treatment for HIV-1 infection (search).
As the first-to-file applicant, Lupin may receive 180-day exclusivity to market its generic equivalent of Merck’s Isentress HD (search).
Raltegravir, used with other antiretrovirals, aims to reduce viral load and improve immune function in HIV-1 infected patients.
Lupin has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Raltegravir Tablets USP, 600 mg. This approval positions Lupin to market a generic equivalent of Merck Sharp & Dohme LLC's Isentress HD (search) Tablets, 600 mg, a significant medication used in the treatment of HIV-1 infection (search). Lupin is the exclusive first-to-file applicant for this product, potentially granting them a 180-day exclusivity period in the U.S. market, which could significantly impact the antiretroviral treatment landscape. The manufacturing of the tablets will be handled by Lupin’s Nagpur facility in India.
Raltegravir, an integrase (search) inhibitor, is a critical component in the management of HIV-1. When used in combination with other antiretroviral agents, Raltegravir Tablets USP, 600 mg, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients and pediatric patients weighing at least 40 kg. The drug works by targeting the HIV-1 integrase enzyme, thereby preventing the integration of viral DNA into the host cell's genome. This action helps to lower viral load and improve immune function in affected individuals.
The reference-listed drug (RLD), Raltegravir Tablets USP, 600 mg (Isentress HD (search)), 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 into the market with a generic option is poised to influence the market dynamics for this antiretroviral treatment, potentially offering a more cost-effective alternative for patients.