Glenmark Pharma Bags US FDA Nod For Ophthalmic Solution

Glenmark Pharmaceuticals Ltd. (Glenmark) has acquired final approval from the US Food and Drug Administration (FDA) for brimonidine tartrate and timolol maleate ophthalmic solution, 0.2%|0.5%. The FDA has decided that Glenmark's brimonidine tartrate and timolol maleate ophthalmic solution, 0.2%|0.5%, is bioequivalent and therapeutically equivalent to AbbVie's Combigan ophthalmic solution, 0.2%|0.5%, and will be supplied in the United States by Glenmark Pharmaceuticals Inc.

Sales data from IQVIA for the 12-month period ending in March 2024 indicates that the Combigan ophthalmic solution, 0.2%|0.5% market brought in about $290.0 million in revenue annually.

Glenmark's current portfolio includes 196 medications that have been authorized for distribution in the United States, as well as 51 ANDAs that are awaiting FDA approval. In addition to these internal filings, Glenmark is actively seeking external development collaborations to augment and accelerate the expansion of its existing pipeline and portfolio.

Glenmark Pharmaceuticals is a research-driven global pharmaceutical company created in 1977 by Gracias Saldanha as a generic medicine. The corporation began selling its products in India, Russia, and Africa. The company went public in India in 1999 and utilized some of the funds to construct its first research center. Glenn, Saldanha's son, took over as CEO in 2001 after returning to India from PricewaterhouseCoopers. By 2008, Glenmark was India's fifth largest pharmaceutical firm.