Glenmark Pharma receives US FDA approval for generic Cardizem SR capsules

Glenmark Pharmaceuticals has received final approval by the United States FDA for diltiazem hydrochloride extended-release capsules USP, 60 mg, 90 mg, and 120 mg. This is the generic version of Cardizem SR extended-release capsules, 60 mg, 90 mg, and 120 mg, of Biovail Laboratories Inc.

The Mumbai-based company has been granted a competitive generic therapy (CGT) designation for diltiazem hydrochloride extended-release capsules USP, 60 mg, 90 mg, and 120 mg, therefore, with this approval, Glenmark is the first approved applicant for such competitive generic therapy and is eligible for 180 days of CGT exclusivity upon commercial marketing.

According to IQVIA sales data for the 12 month period ending January 2021, the Cardizem SR extended-release capsules, 60 mg, 90 mg, and 120 mg market2 achieved annual sales of approximately $56.7 million.

The company’s current portfolio consists of 170 products authorized for distribution in the US marketplace and 42 ANDA’s pending approval with the US 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.