Drug firm Alembic Pharmaceuticals on Monday said it has received final nod from the US health regulator for its Timolol Maleate ophthalmic gel-forming solution used for the treatment of elevated intraocular pressure. The company has received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Timolol Maleate ophthalmic gel-forming solution, 0.25 per cent and 0.5 per cent, Alembic Pharma said in a filing to BSE.
The product is a generic version of Bausch Health US' Timoptic-XE ophthalmic gel-forming solution in the same strengths, it added.
The company "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," Alembic Pharma said.
This application has been co-developed in partnership with Orbicular Pharmaceutical Technologies, it added.
According to IQVIA, Timolol Maleate ophthalmic gel-forming solution, 0.25 per cent and 0.5 per cent has an estimated market size of USD 71 million for the 12 months ending June 2020, Alembic Pharma said.
The product is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma, it added.
Shares of Alembic Pharmaceuticals were trading at Rs 949.25 per scrip on BSE, down 2.51 per cent from its previous close.
(With PTI inputs)