Glenmark Pharmaceuticals receives ANDA approval for Esomeprazole Magnesium Delayed-Release Capsules

The drug is a generic version of Nexium Delayed-Release Capsules, 20 mg and 40 mg, of AstraZeneca Pharmaceuticals LP

Glenmark has been granted final approval by the United States Food & Drug Administration (US FDA) for Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg and 40 mg, a generic version of Nexium Delayed-Release Capsules, 20 mg and 40 mg, of AstraZeneca Pharmaceuticals LP.

“According to IQVIATM sales data for the 12 month period ending March 2019, the Nexium Delayed- Release Capsules, 20 mg and 40 mg market achieved annual sales of approximately $395.1 million,” the press release by the company stated.

Glenmark’s current portfolio consists of 153 products authorized for distribution in the US marketplace and 58 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,” the press release added.