Global pharma major Lupin Limited has received approval for its emtricitabine and tenofovir disoproxil fumarate tablets, 200 mg/300 mg, from the United States Food and Drug Administration (FDA), to market a generic equivalent of Truvada tablets, 200 mg/300 mg, of Gilead Sciences, Inc.

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

Emtricitabine and tenofovir disoproxil fumarate tablets, 200 mg/300 mg, are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. It is also used for for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection.

Emtricitabine and tenofovir disoproxil fumarate tablets had estimated annual sales of US$ 2.1 billion in the US, according to IQVIA MAT March 2021).