Glenmark Pharmaceuticals Ltd. (Glenmark) has secured final approval from the United States Food & Drug Administration (U.S. FDA) for their Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution, 0.2%|0.5%. This solution has been confirmed by the FDA to be both bioequivalent and therapeutically equivalent to Combigan® Ophthalmic Solution, 0.2%|0.5%, produced by AbbVie, Inc. Glenmark will handle the distribution of this product in the U.S. through Glenmark Pharmaceuticals Inc., USA.

Combigan® Ophthalmic Solution, a combination of Brimonidine Tartrate and Timolol Maleate, recorded annual sales of approximately $290.0 million in the U.S. market for the 12 months ending March 2024, according to IQVIA™ sales data.

With this new approval, Glenmark’s portfolio now includes 196 products authorized for distribution in the U.S., alongside 51 ANDA applications currently pending approval with the U.S. FDA. Glenmark remains committed to expanding its pipeline and portfolio through both internal developments and strategic external partnerships.

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