Lupin Limited has received United States Food and Drug Administration (US FDA) approval for its Abbreviated New Drug Application (ANDA) for raltegravir tablets USP, 600 mg. The approval enables Lupin to market a generic equivalent of Merck's Isentress HD, with the potential for 180 days of marketing exclusivity in the US.

Key Highlights

FDA approval for HIV medication

• The approved product is a generic version of Isentress HD (600 mg) of Merck Sharp & Dohme LLC.

• Raltegravir is approved for use in combination with other antiretrovirals for the treatment of HIV-1 infection in adult patients and pediatric patients with a body weight of ≥40 kg.

First-to-File status

• Lupin is the sole first-to-file applicant, conferring on it 180 days of generic exclusivity in the US market.

• The product will be produced at Lupin's Nagpur plant in India.

Market opportunity
Raltegravir tablets USP, 600 mg had an estimated US sales of USD 34 million for the 12 months ended March 2025 (IQVIA).Lupin's US FDA approval of Raltegravir is another step in its growing global generics portfolio. With first-to-file status and exclusivity in the US market, the company will be able to reinforce its presence in the HIV therapeutic segment as well as take advantage of domestic manufacturing capabilities.