Granules India receives ANDA approval for Esomeprazole Magnesium Delayed-Release capsules

Esomeprazole Magnesium capsules are indicated for short-term treatment of heartburn and other symptoms associated with GERD and risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcers in adults at risk for developing gastric ulcers.

Updated On Oct 19, 2023 at 06:21 PM IST

Hyderabad: Granules India Limited announced that the US Food & Drug Administration (US FDA) has approved its abbreviated new drug application (ANDA) for Esomeprazole Magnesium Delayed-Release Capsules USP, 20mg and 40mg. It is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Nexium Delayed-Release Capsules, 20mg and 40mg, of AstraZeneca Pharmaceuticals LP.

Esomeprazole Magnesium capsules are indicated for short-term treatment of heartburn and other symptoms associated with GERD, risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcers in adults at risk for developing gastric ulcers, helicobacter pylori eradication to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin, and long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

Granules now have a total of 62 ANDA approvals from the US FDA (60 final and two tentative approvals).

The current annual US market for Esomeprazole Magnesium Delayed-Release Capsules is approximately $168 million, according to MAT July 2023, IQVIA/IMS Health.