Glenmark Pharmaceuticals Ltd. on Friday announced that it has received final approval from the United States Food & Drug Administration (U.S. FDA) for Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution, 0.2%|0.5%.
According to the company’s statement, Glenmark’s Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution, 0.2%|0.5% has been determined by the FDA to be bioequivalent and therapeutically equivalent to Combigan Ophthalmic Solution, 0.2%|0.5%, of AbbVie, Inc.
The eye medicines will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA. The drugs are used to open-angle glaucoma or high fluid pressure in the eye.
According to IQVIATM sales data for the 12-month period ending March 2024, the Combigan Ophthalmic Solution, 0.2%|0.5% market achieved annual sales of approximately $290.0 million.
Glenmark’s current portfolio consists of 196 products authorized for distribution in the U.S. marketplace and 51 ANDA’s pending approval with the U.S. FDA.
In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.
