Shares of Alembic Pharma
gained 1% on Monday after the company 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), the company said in a press note to the exchanges released on Monday.
Teriflunomide tablets are indicated for the treatment of patients with relapsing forms of multiple sclerosis.
The drug has an estimated market size of $1.6bn 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.
The company now has a total of 91 ANDA approvals (79 final approvals and 12 tentative approvals) from USFDA.
Alembic Pharmaceuticals Ltd's share price is currently at Rs541.85, up by Rs7.45 or 1.39%, from its previous close of Rs534.40 on the BSE.
The scrip opened at Rs536 and has touched a high and low of Rs541.85 and Rs535.50, respectively. So far, 14,086 (NSE+BSE) shares have been traded on the counter. The current market cap of the company is Rs10,073.44cr.