Schering-Plough Files Application for OTC Heartburn Drug

Schering-Plough has submitted a new drug application for 20-mg Zegerid as an OTC product to treat frequent heartburn.

The company acquired exclusive U.S. and Canadian rights to market OTC proton pump inhibitor products using proprietary technology under a 2006 license agreement with Santarus.

Under the agreement, Santarus received a $15 million upfront license fee and is entitled to an additional $65 million in milestone payments. Santarus continues to manufacture and sell Zegerid (omeprazole/sodium bicarbonate) prescription products in both 20- and 40-mg strengths in the U.S.

The U.S. OTC heartburn market generated an estimated $1.6 billion sales in 2007, based on data from market research firm A.C. Nielsen and Santarus’ calculations.