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

Press Release

For Immediate Distribution

Glenmark Pharmaceuticals receives ANDA approval for

Brimonidine Tartrate and Timolol Maleate

Ophthalmic Solution, 0.2%|0.5%

Mahwah, New Jersey, USA and Mumbai, India, May 17, 2024: 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.

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About Glenmark Pharmaceuticals Ltd.

Glenmark Pharmaceuticals Ltd. (BSE: 532296 | NSE: GLENMARK) 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. The company has 11 world-class manufacturing facilities spread across 4 continents, and operations in over 80 countries. In Vivo/Scrip 100 positions Glenmark amongst the Top 100 Companies Ranked by R&D and Pharmaceutical Sales, 2022; while Generics Bulletin/In Vivo places it in the Top 50 Generics and Biosimilars Companies Ranked by Sales, 2022. Glenmark's Green House Gas (GHG) emission reduction targets have been approved in 2023 by the Science Based Target initiative (SBTi), making it only the second pharmaceutical company in India to achieve this. The organization has impacted around 3 million lives over the last decade through its CSR interventions. For more information, visit www.glenmarkpharma.com. You can follow us on LinkedIn (Glenmark Pharmaceuticals) and Instagram (glenmark_pharma).

For more information, please contact

Udaykumar Murthy | [e-mail]| [phone]

References:

1Glenmark'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.

2All brand names and trademarks are the property of their respective owners.

3Market includes brand and all available therapeutic equivalents *IQVIATM National Sales Perspectives: Retail & Non-Retail, March 2024