Overview
Gland Pharma Limited, a generic injectable-focused pharmaceutical company, has received tentative approval from the United States Food and Drug Administration (FDA) for latanoprostene bunod ophthalmic solution, 0.024%.
The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Vyzulta ophthalmic solution, 0.024%, registered by Bausch & Lomb Inc. (Bausch & Lomb)
1st ANDA Applicant
- Based on the available updates, the company believes that it is the first applicant to have filed its ANDA with Paragraph IV certification.
- Upon final approval, the company may be eligible for 180 days of generic drug exclusivity.
Latanoprostene Bunod Ophthalmic Solution
- Latanoprostene bunod ophthalmic solution, 0.024%, is indicated for reducing elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
- According to IQVIA, the product had US sales of approximately USD 153 million for the twelve months ended December 2023.
Gland Pharma
- Gland Pharma was established in 1978 in Hyderabad and has grown over the years from a contract manufacturer of small-volume liquid parenteral products to become one of the largest injectable-focused companies, with a global footprint across 60 countries, including the United States, Europe, Canada, Australia, India, and other markets.
