On Tuesday, drug company Lupin said it had received approval from the US health regulator USFDA to market Darunavir Tablets in the American market. These tablets are used to treat Human Immunodeficiency Virus (HIV) infection.

The Mumbai-based pharmaceutical company said it is the exclusive first filer for 800 mg tablets and is eligible for 180-day exclusivity. The company will also potentially have shared 180-day exclusivity on the 600 mg tablets.

The firm has received assent from the US Food and Drug Administration for the medication in strengths of 600 mg and 800 mg. Reportedly, Lupin’s product is a generic equivalent of Janssen Products’ Prezista Tablets. As per MAT data, Darunavir tablets (600 mg and 800 mg) had estimated annual sales of USD 343 million in the US.

Founded by Desh Bandhu Gupta in 1968, Lupin Limited is an Indian multinational pharmaceutical company. Lupin is one of the largest generic pharmaceutical firms worldwide by revenue.

Headquartered in Mumbai, the company’s focus areas include paediatrics, cardiovascular, diabetology, asthma and anti-tuberculosis. The company’s shares were trading 2.17 per cent, up at Rs 738.30 per share on the BSE.