Glenmark Pharma gets ANDA approval for diltiazem hydrochloride ER capsules

Glenmark Pharmaceuticals has received final approval by the United States Food and Drug Administration (US FDA) for diltiazem hydrochloride extended release capsules USP, 60 mg, 90 mg, and 120 mg, the generic version of Cardizem1 SR extended release capsules, 60 mg, 90 mg, and 120 mg, of Biovail Laboratories.

Glenmark 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 IQVIATM sales data for the 12 month period ending January 2021, the Cardizem SR extended release capsules, 60 mg, 90 mg, and 120 mg market achieved annualsales of approximately
$56.7 million.

Glenmark’s current portfolio consists of 170 products authorised 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.