Indoco Remedies announces the launch of brinzolamide ophthalmic suspension 1% in the United States, the first generic version of Azopt by Teva Pharmaceuticals.
The product is developed and manufactured by Indoco Remedies Ltd for Teva at its facility in Goa.
The ANDA approved by the US Food and Drug Administration for brinzolamide ophthalmic suspension 1%, is used to treat high pressure inside the eye due to ocular hypertension and open-angle glaucoma.
Brinzolamide ophthalmic suspension 1% works by decreasing the amount of fluid within the eye.
The US market size of this product is $184 million, according to IQVIA data as of December, 2020.
Commenting on this achievement, Aditi Kare Panandikar, managing director, Indoco Remedies Ltd. said, “This first-to-market generic version of Azopt (brinzolamide ophthalmic suspension 1%, developed by Indoco) in the US brings in an enormous opportunity to Indoco to serve the patients with a generic option. It also provides us immense satisfaction to be part of the journey in developing and securing approval from the US regulators for such complex generic products (ophthalmic suspensions), ensuring access to affordable and quality medicines.”
Panandikar also added, “Indoco is vertically integrated for brinzolamide API (manufactured at Patalganga site), which gives an edge to ensure continuity in commercial supplies.”