Pharmaceutical company Lupin said on Monday it had received approval from US health regulators to market its Tenofovir Alafenamide tablets to treat chronic hepatitis B virus infection in the US market. Lupin said in a statement that the company had received provisional approval from the US Food and Drug Administration (FDA) for an abbreviated new drug application for tenofovir alafenamide tablet (25 mg).

The Mumbai-based company’s product is the generic equivalent of Gilead Sciences’ Vemlidy tablet. The product will be manufactured at the company’s factory in Nagpur, Lupin said. According to IQVIA MAT data for December 2021, annual US sales of tenofovir alafenamide tablets are estimated at $484.2 million.