Glenmark Pharmaceuticals Ltd announced today that it has received final approval from the US Food & Drug Administration (USFDA) for its generic brimonidine tartrate and timolol maleate ophthalmic solution. This medication is indicated for the treatment of increased intraocular pressure caused by glaucoma or other eye conditions.
The approved ophthalmic solution, with strengths of 0.2 percent and 0.5 percent, has been recognized by the USFDA as bioequivalent and therapeutically equivalent to the reference listed drug Combigan ophthalmic solution (0.2 percent/0.5 percent) by AbbVie, Inc.
Glenmark Pharmaceuticals will distribute the newly approved solution in the United States through its subsidiary, Glenmark Pharmaceuticals Inc., USA. This development is a significant milestone for the company as it expands its presence in the US pharmaceutical market.
According to IQVIA™ sales data, Combigan ophthalmic solution achieved annual sales of approximately USD 290 million for the 12-month period ending March 2024. Glenmark’s entry into this market with a generic equivalent is expected to provide a more cost-effective option for patients and healthcare providers dealing with glaucoma and other related conditions.
Glenmark Pharmaceuticals’ successful approval underscores the company’s ongoing commitment to developing and delivering high-quality generic medications. The company continues to leverage its extensive research and development capabilities to provide affordable treatment options in the ophthalmic therapeutic area.
This latest USFDA approval is expected to enhance Glenmark’s portfolio and strengthen its competitive position in the generic pharmaceutical market, further supporting its mission to improve patient access to essential medications
