Gland Pharma Limited has informed the Exchange regarding a press release dated Jun 04, 2025, titled "Gland Pharma receives approval from the United States Foodand Drug Administration (USFDA) for Angiotensin II Acetate Injection 2.5 mg/mL".
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Gland Pharma has received USFDA approval for its generic Angiotensin II Acetate Injection 2.5 mg/mL, used to raise blood pressure in adults with septic or distributive shock. The product is bioequivalent to the branded drug GIAPREZA, which recorded US sales of about USD 58 million in the 12 months ending March 2025, per IQVIA. Gland Pharma is the exclusive First-to-File on this product, making it eligible for 180 days of generic drug exclusivity in the US market before other generic competitors can launch. This adds a high-value, low-competition product to Gland's US portfolio in the complex injectable space.
Positive for shareholders — Gland can now sell a niche but high-margin US product with a six-month monopoly, which should boost US revenue and earnings in the near term. However, 180-day exclusivity is temporary, and actual revenue capture will depend on launch speed and market share.