Drug maker Lupin on Friday said it has received approval from the US health regulator to market a generic product, used in the treatment of a lung disease, in the American market.

The company has received approval from the US Food and Drug Administration (USFDA) to market Pirfenidone tablets in strengths of 267 mg and 801 mg, the Mumbai-based drug maker said in a statement.

The company’s product is the generic equivalent of La Roche Inc’s Esbriet tablets, it added.

Pirfenidone is used for the treatment of idiopathic pulmonary fibrosis.

As per IQVIA MAT data, Pirfenidone tablets had estimated annual sales of USD 218 million in the US. 

Lupin Ltd. (Lupin) develops and produces biotechnology goods, active pharmaceutical ingredients (APIs), and generic and branded formulations. It has knowledge of cardiovascular, asthma, diabetes management, paediatrics, gastro-intestinal, anti-infectives, nonsteroidal anti-inflammatory medications (NSAIDs), anti-TB, and cephalosporins. It also has knowledge of the central nervous system.

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