Lupin bags USFDA okay for idiopathic pulmonary fibrosis drug Pirfenidone

Mumbai: Global pharma major Lupin Limited today announced that the company has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Pirfenidone Tablets, 267 mg and 801 mg, to market a generic equivalent of Esbriet Tablets, 267 mg and 801 mg of Hoffmann La Roche Inc. 

Pirfenidone is used to treat idiopathic pulmonary fibrosis (IPF). IPF is a rare and progressive respiratory disorder marked by the thickness and stiffening of lung tissue as well as the production of scar tissue. It's a form of chronic scarring lung disease that causes a steady reduction in lung function that's irreversible. Shortness of breath and a dry cough are two of the most common symptoms. Other symptoms include fatigue and unusually large, dome-shaped fingers and toenails. Pulmonary hypertension, heart failure, pneumonia, and pulmonary embolism are all possible complications.

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

Pirfenidone Tablets (RLD Esbriet) had estimated annual sales of USD 218 million in the U.S. (IQVIA MAT June 2023).

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Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions. The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. The company invested 7.9% of its revenue in research and development in FY23. Lupin has 15 manufacturing sites, 7 research centers.

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