Glenmark receives ANDA approval for Icatibant Injection

This marks Glenmark's first synthetic decapeptide injectable approval

Glenmark Pharmaceuticals Limited (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Icatibant Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Prefilled Syringe, the generic version of Firazyr®1 Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Prefilled Syringe, of Shire Human Genetic Therapies, Inc. This marks Glenmark's first synthetic decapeptide injectable approval and will be manufactured in their North American manufacturing facility based in Monroe, North Carolina.

According to IQVIA sales data for the 12 month period ending March 2021, the Firazyr® Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Prefilled Syringe market2 achieved annual sales of approximately $223.4 million.

Glenmark's current portfolio consists of 172 products authorized for distribution in the U.S. marketplace and 44 ANDA's pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.