Collaborations & Alliances, Trials & Filings

Amneal Launches Nexium Alternative

Releases 505(b)(2) product in parternship with Hanmi

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Amneal Pharmaceuticals has launched its branded Esomeprazole Strontium 49.3 mg delayed-release capsules. Esomeprazole Strontium contains the same active moiety (esomeprazole) in a different salt form as found in the branded proton-pump inhibitor Nexium (esomeprazole magnesium) and is a new option for adult patients for the short term treatment of gastroesophageal reflux disease (GERD).

Amneal is marketing the 505(b)(2) product in the U.S. under an exclusive license and distribution agreement with Hanmi Pharmaceutical Co. Ltd of South Korea. Each 49.3 mg strength Esomeprazole Strontium capsule provides the equivalent of 40 mg of esomeprazole base, an equivalent amount of esomeprazole that is present in the corresponding Nexium dose. Esomeprazole Strontium capsules are offered in 30-count bottles, according to the company. Esomeprazole Strontium is manufactured in the U.S.

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