Glenmark Pharma receives US FDA approval for brimonidine tartrate and timolol maleate ophthalmic solution, 0.2%|0.5%
Overview
Glenmark Pharmaceuticals Ltd. (Glenmark) has received final approval by the United States Food & Drug Administration (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 equivalent to Combigan ophthalmic solution, 0.2%|0.5%, of AbbVie, Inc., and will be distributed in the US by Glenmark Pharmaceuticals Inc., USA.
Approximate Annual Sales
According to IQVIA 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 Portfolio
- Glenmark’s current portfolio consists of 196 products authorized for distribution in the US marketplace and 51 ANDA’s pending approval with the US 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.
Glenmark Pharmaceuticals
Glenmark Pharmaceuticals Ltd. is a research-led, global pharmaceutical company, having a presence across branded, generics, and OTC segments; with a focus on therapeutic areas of respiratory, dermatology and oncology.
