Alembic Pharmaceuticals Ltd on

Friday said it has received

tentative approval from the US

health regulator for its generic

Vortioxetine tablets indicated for

the treatment of the major

depressive disorder.

The tentative approval granted

by the US Food & Drug

Administration (USFDA) for its

abbreviated new drug application

(ANDA) for Vortioxetine tablets of strengths in 5 mg, 10 mg, 15 mg and 20 mg, the These are therapeutically equivalent to the reference listed drug product (RLD)

Trintellix tablets 5 mg, 10 mg, 15 mg, and 20 mg of Takeda Pharmaceuticals,

USA, Inc, it added. Citing IQVIA data, the company said these Vortioxetine tablets have an estimated

market size of USD 1,249 million for twelve months ending September 2021.

Alembic, however, said it is currently in litigation with H Lundbeck in the Court of

appeals for the Federal Circuit and the launch of the product will depend on

litigation outcome.

"It is possible that our ANDA may not be indicated for certain uses due to

unexpired exclusivities for the RLD for such uses