Gland Pharma Limited has informed the Exchange regarding a press release dated April 30, 2025, titled "Gland Pharma Receives Approval from USFDA for Latanoprostene Bunod Ophthalmic Solution".
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Gland Pharma has received approval from the USFDA for its generic version of Latanoprostene Bunod Ophthalmic Solution (0.024%), used to treat open-angle glaucoma and ocular hypertension. The product is a generic equivalent of Bausch and Lomb's VYZULTA, which had US sales of about USD 171 million in the 12 months ending February 2025, according to IQVIA. Importantly, Gland Pharma is the exclusive First-to-File applicant, making it eligible for 180 days of generic drug exclusivity in the US market before other generic competitors can launch. This strengthens the company's ophthalmic portfolio and provides a meaningful revenue opportunity in its core US market. The company operates across 60 countries and is one of the largest injectable-focused pharmaceutical firms in India.
This is a positive development for shareholders. The First-to-File status with 180 days of exclusivity means Gland Pharma will likely capture a significant share of the USD 171 million US market before competition enters, which could meaningfully boost revenues and margins in the near to medium term.