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24 May 2022, Mumbai: Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Pirfenidone Tablets, 267 mg and 801 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Esbriet Tablets, 267 mg and 801 mg, of Genentech, Inc. (Genentech). Pirfenidone Tablets are indicated for the treatment of idiopathic pulmonary fibrosis (IPF). Alembic had previously received tentative approval for this ANDA. Alembic was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification. It may not be indicated for certain other uses due to unexpired exclusivities for the RLD for such uses.
Pirfenidone Tablets, 267 mg and 801 mg have an estimated market size of US$ 548 million for twelve months ending December 2021 according to IQVIA. Alembic has settled the case with Genetech and will launch its generic as per the terms of settlement.
Alembic has a cumulative total of 167 ANDA approvals (144 final approvals and 23 tentative approvals) from USFDA.
