The tentatively approved abbreviated new drug application (ANDA) is therapeutically equivalent to the reference listed drug product (RLD) Multaq Tablets of Sanofi-Aventis U.S. LLC.
Dronedarone is indicated to reduce, the risk of hospitalization for atria) fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation.
The tablets have an estimated market size of US$ 500 million for twelve months ending September 2021 according to IQVIA.
Alembic has settled the case with Sanofi-Aventis and will launch its generic as per the terms of settlement.
Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world.
On a consolidated basis, the drug makers net profit dropped 49.22% to Rs 169.29 crore on 11.31% decline in sales to Rs 1,292.32 crore in Q2 FY22 over Q2 FY21.
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