SAN DIEGO Santarus on Tuesday announced that it has achieved a $2.5 million regulatory milestone under its over-the-counter license agreement with Schering-Plough Healthcare Products for the proton-pump inhibitor/sodium bicarbonate disgestive Zegerid.
The sodium bicarbonate raises the gastric pH and protects omeprazole from acid degradation.
Schering-Plough is currently seeking Food and Drug Administration Zegerid as a non-prescription product, which, if approved before Novartis Consumer successfully switches Prevacid, would be the second PPI to reach the OTC market after Procter & Gamble’s Prilosec OTC.
Under the agreement, Schering-Plough is responsible for the development, manufacturing and commercialization of Zegerid branded OTC products with the dosage strength of 20 mg of omeprazole for heartburn-related indications in the U.S. and Canada. Santarus is continuing to manufacture, promote and sell its Zegerid prescription products in both 20 mg and 40 mg dosage strengths of omeprazole in the U.S. prescription market for PPI products.