Alembic Pharma slips over 4 per cent despite getting USFDA nod for Ophthalmic solution

Alembic Pharmaceuticals Limited, an Indian multinational pharmaceutical company, announced today that it has been granted final approval by US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic solution USP, 2 per cent and 0.5 per cent.  

So far, the company has a cumulative total of 143 ANDA approvals (125 final approvals and 18 tentative approvals) from USFDA.   

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Cosopt Ophthalmic solution, 2 per cent, and 0.5 per cent, of Akorn Operating Company LLC. Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic solution is a combination of dorzolamide hydrochloride carbonic anhydrase inhibitor, and timolol maleate, a beta-adrenergic receptor blocking agent indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, who are insufficiently responsive to beta-blockers.   

The estimated market size of the approved products, Dorzolamide Hydrochloride and Tirnolol Maleate Ophthalmic solution USP, 2 per cent and 0.5 per cent, is US$ 80 million for twelve-month ending December 2020, according to IQVIA.   

At 2.04 pm on Wednesday, the share price of Alembic Pharmaceuticals Limited was trading at Rs 960.00, a decrease of 4.65 per cent from its previous day’s closing price of Rs 1,006.80 on BSE.