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

Glenmark Pharmaceuticals has received final approval by the USFDA 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 (1) to Combigan (2) Ophthalmic Solution, 0.2%|0.5%, of AbbVie, and will be distributed in the US by Glenmark Pharma Inc., USA.

According to IQVIA sales data for the 12-month period ending March 2024, the Combigan Ophthalmic Solution, 0.2%|0.5% market (3) achieved annual sales of approximately $290 million*. 

Glenmark’s current portfolio consists of 196 products authorised for distribution in the US marketplace and 51 ANDA’s pending approval with the USFDA.

References:

• Glenmark’s Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution, 0.2%|0.5% is only approved for the indication(s) listed in Glenmark’s approved label.

• All brand names and trademarks are the property of their respective owners.
• Market includes brand and all available therapeutic equivalents

*IQVIA National Sales Perspectives: Retail & Non-Retail, March 2024