Glenmark Pharmaceuticals Ltd. secured final approval from the United States Food & Drug Administration (FDA) for its Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution, 0.2%|0.5%. The company informed that the solution was deemed bioequivalent and therapeutically equivalent to Combigan Ophthalmic Solution, 0.2%|0.5%, produced by AbbVie, Inc. Glenmark Pharmaceuticals Inc., USA will distribute the product in the US.
According to IQVIA sales data for the 12-month period ending March 2024, the market for Combigan Ophthalmic Solution, 0.2%|0.5%, reached annual sales of approximately $290 million.
Glenmark’s current US portfolio includes 196 products authorised for distribution and 51 Abbreviated New Drug Applications (ANDAs) awaiting approval from the FDA. The company informed they are actively seeking external development partnerships to expand its existing pipeline and portfolio.
The shares were up by 1.02% to ₹1016.45 at 11 am on the BSE.