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Zegerid

Valeant Pharmaceuticals International, Inc.

Drug Names(s): omeprazole/sodium bicarbonate/magnesium hydroxide, Zegerid with magnesium hydroxide, Zegerid OTC

Description: Zegerid contains omeprazole, a proton pump inhibitor (PPI), and sodium bicarbonate, an antacid, which raises the gastric pH and thus protects omeprazole from acid degradation.

Zegerid was first approved as a powder for oral suspension but is now available as an oral capsule and chewable oral tablet. An tablet formulation has also been approved.

Deal Structure: Santarus and University of Missouri
In January 2001, Santarus entered into an exclusive, worldwide license agreement with the University of Missouri for all of its patents and pending patent applications relating to specific formulations of PPIs with antacids and other buffering agents. Pursuant to the terms of the license agreement, Santarus paid the University of Missouri an upfront licensing fee of $1.0 million in 2001, a one-time $1.0 million milestone fee in 2003 following the filing of the first NDA and a one-time $5.0 million milestone fee in July 2004 following the FDA's approval of Zegerid Powder for Oral Suspension 20 mg. Santarus is required to make additional milestone payments to the University of Missouri upon the achievement of certain regulatory events related to obtaining approvals outside the U.S. which may total up to $3.5 million in the aggregate. Santarus are also required to make milestone payments based on first-time achievement of significant sales...See full deal structure in Biomedtracker

Partners: Norgine B.V.


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