Alembic Pharma gets USFDA approval to market Pirfenidone tablets

Alembic Pharmaceuticals advanced 1.03% to Rs 768.20 after the company announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for pirfenidone tablets.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Esbriet Tablets, of Genentech, Inc. (Genentech).

Pirfenidone is used to treat a certain lung disease called idiopathic pulmonary fibrosis (IPF). The disease causes the lungs to get scarred and become stiff, making it hard to breathe.

According to IQVIA, Pirfenidone Tablets have an estimated market size of $548 million for twelve months ending December 2021. The company has settled the case with Genetech and will launch as per the terms of the settlement. Alembic has a cumulative total of 167 ANDA approvals (144 final approvals and 23 tentative approvals) from USFDA.