FDA gives Lupin tentative nod for generic Isentress

Lupin has received tentative approval from the Food and Drug Administration for raltegravir tablets, 600 mg, which is a generic of Merck Sharp & Dohme’s Isentress HD tablets. 

Lupin is the exclusive first-to-file for this product and may be eligible to receive a 180-day exclusivity. 

[Read more: Lupin receives FDA OK for generic Banzel]

Raltegravir tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus infection in adult patients and in pediatric patients weighing at least 40 kg.

This product will be manufactured at Lupin’s Nagpur facility in India.

Raltegravir tablets 600 mg had a market value of roughly $36 million, per IQVIA September 2024 data.

[Read more: Lupin rolls out generic Doxil]