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.
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Alembic Pharmaceuticals Ltd on Friday said it has gotten tentative endorsement from the US health regulator for its generic Vortioxetine tablets demonstrated for the treatment of the major depressive disorder. The tentative endorsement conceded by the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Vortioxetine tablets of qualities in 5 mg, 10 mg, 15 mg and 20 mg, the organization said in an assertion. These are therapeutically comparable 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.
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, the company said.