All Eyes on Gland Pharma: First-to-File Status Promises 180 Days of U.S. Market Dominance

Gland Pharma Limited has received approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Latanoprostene Bunod Ophthalmic Solution, 0.024%. This generic version is therapeutically equivalent to Bausch & Lomb’s Vyzulta and is indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension-serious eye conditions that can lead to vision loss if untreated.

 

Gland Pharma is the first company to file its ANDA with Paragraph IV certification for this product, making it eligible for 180 days of marketing exclusivity upon final approval. This exclusivity provides Gland Pharma a significant competitive advantage in the U.S. market, with the product’s U.S. sales estimated at $153 million for the twelve months ended December 2023.

 

This approval strengthens Gland Pharma’s growing U.S. portfolio, especially in the complex generics and ophthalmic segments. The company’s management highlighted that this milestone underscores its commitment to expanding its presence in regulated markets and delivering high-quality, affordable medicines globally.

 

Source: CNBC-TV18, India Infoline, Express Pharma, Angel One