Lupin Gets USFDA Nod For HIV Drug Raltegravir, Bags 180-Day Exclusivity

Lupin Ltd. on Thursday said it has received approval from the US Food and Drug Administration for its abbreviated new drug application for Raltegravir tablets, 600 mg.

Raltegravir is the generic version of Merck Sharp & Dohme LLC’s Isentress HD tablets. The drug is used with other antiretroviral agents to treat HIV infection in adults and in children weighing at least 40 kg, the company said in an exchange filing.

Lupin is the exclusive first-to-file applicant for this product and is eligible for 180 days of marketing exclusivity in the US. The drug will be manufactured at Lupin’s facility in Nagpur, Maharashtra.

Citing IQVIA data, the company said Raltegravir tablets had estimated annual US sales of $34 million in the year ended March.