Lupin Limited has secured tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Raltegravir Tablets USP, 600 mg. This approval paves the way for Lupin to market a generic equivalent of Merck Sharp & Dohme's Isentress HD Tablets, 600 mg, used in the treatment of HIV-1 infection.
Lupin's First-to-File Status
Notably, Lupin holds the distinction of being the exclusive first-to-file for this generic product. This status potentially grants Lupin a 180-day exclusivity period, providing a significant market advantage upon final approval and launch.
Manufacturing and Indication
The Raltegravir tablets will be manufactured at Lupin’s facility located in Nagpur, India. The tablets are indicated for use in combination with other antiretroviral medications in both adult and pediatric patients (weighing at least 40 kg) infected with HIV-1.
Market Context
According to IQVIA data, the annual sales for Raltegravir Tablets USP, 600 mg (reference listed drug Isentress HD) reached approximately USD 36 million in the U.S. market as of September 2024. The introduction of a generic alternative by Lupin is expected to provide a more cost-effective treatment option for patients.
