Glenmark Pharmaceuticals receives ANDA approval for Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution, 0.2%|0.5%

Glenmark Pharmaceuticals Ltd. (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution, 0.2%|0.5%. Glenmark’s Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution, 0.2%|0.5% has been determined by the FDA to be bioequivalent and therapeutically equivalent¹ to Combigan®² Ophthalmic Solution, 0.2%|0.5%, of AbbVie, Inc., and will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA.

According to IQVIATM sales data for the 12-month period ending March 2024, the Combigan® Ophthalmic Solution, 0.2%|0.5% market³ 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.