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Breckenridge set to release Prilosec generic

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BOCA RATON, Fla. — Breckenridge Pharmaceutical Inc. has earned Food and Drug Administration approval for omeprazole delayed-release capsules, an antacid, in 10-mg, 20-mg, 40-mg dosages.

Breckenridge said its omeprazole product, AB-rated to AstraZeneca’s Prilosec, will be manufactured and supplied by its parent company, Laboratorios Dr. Esteve S.A., based in Barcelona, Spain. Launch plans are under way.

A proton pump inhibitor (PPI), omeprazole is used to treat certain stomach and esophagus issues such as gastroesophageal reflux disease (GERD) and ulcers.

U.S. market sales of omeprazole market topped $266.8 billion for the 12-month period through April, Breckenridge reported.

Breckenridge added that the approval is part of its growing portfolio of vertically integrated products with Esteve, with the product’s API manufactured by Esteve’s API division, Esteve Quimica.


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