Alembic Pharma gets US FDA approval for timolol maleate

Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) timolol maleate ophthalmic gel forming solution, 0.25 per cent and 0.5 per cent.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Timoptic-XE ophthalmic gel forming solution, 0.25 per cent and 0.5 per cent, of Bausch Health US.

Timolol maleate ophthalmic gel forming solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.

Alembic has been granted a Competitive Generic Therapies (CGT) designation for this ANDA and it is eligible for 180 days of CGT exclusivity as it is the first approved ANDA.

According to IQVIA, for 12 months ending June 2020, timolol maleate ophthalmic gel forming Solution, 0.25 per cent and 0.5 per cent has an estimated market size of US$ 71 million.

This ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies. It has a cumulative total of 134 ANDA approvals (117 final approvals and 17 tentative approvals) from US FDA.