Alembic Pharma gets tentative generic nod for Allergan’s Latisse

Alembic Pharmaceuticals said it received tentative approval from the US Food & Drug Administration for launching a therapeutic equivalent of Latisse ophthalmic solution.

Allergan Bimatoprost solution is used to treat loss of hair, or hypotrichosis, of the eyelashes.

The solution, with an estimated US market size of $63 million, increases the length, thickness and darkness of eyelashes.

Tentative approval is given when the branded version of the drug is yet to lose its patent protection, and the company will not be able to launch its equivalent product immediately.

Alembic is currently in litigation with Allergan in District Court of New Jersey and the launch of this product will depend on the outcome of litigation, the Indian company said.

Alembic now has a total of 76 ANDA approvals (64 final approvals and 12 tentative approvals) from USFDA.