Alembic has a total of 134 ANDA approvals (117 final and 17 tentative) from the US drug regulator.
Alembic Pharmaceuticals share price slipped 2 percent intraday on October 26 even though the company received final approval from the US Food and Drug Administration (USFDA) for a glaucoma drug.
The company received the go-ahead from USFDA for its Abbreviated New Drug Application (ANDA) Timolol Maleate Ophthalmic Gel Forming Solution, 0.25% and 0.5%.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Timoptic-XE Ophthalmic Gel Forming Solution, 0.25% and 0.5%, of Bausch Health US, LLC.
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. CGT exclusivity as it is the first approved ANDA.
Timolol Maleate Ophthalmic Gel Forming Solution has an estimated market size of $71 million for 12-month ending June 2020, according to IQVIA.
This ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies Pvt Ltd.
Alembic has a total of 134 ANDA approvals (117 final and 17 tentative approvals) from USFDA.At 1138 hours, Alembic Pharmaceuticals was quoting at Rs 963.00, down Rs 10.75, or 1.10 percent on the BSE.