Alembic Pharmaceuticals Limited announced that the company has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Teriflunomide Tablets, 7 mg and 14 mg.
The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Aubagio Tablets, 7 mg and 14 mg, of Sanofi-Aventis U.S., LLC (Sanofi-Aventis). Teriflunomide tablets are indicated for the treatment of patients with relapsing forms of multiple sclerosis.
Teriflunomide Tablets, 7 mg and 14 mg have an estimated market size of US$ 1.6 billion for twelve months ending December 2018 according to IQVIA. Alembic has settled the litigation and will launch the product as per the terms of the settlement.
Alembic now has a total of 91 ANDA approvals (79 final approvals and 12 tentative approvals) from USFDA.
