Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that RLL has received tentative approval from the U.S. Food and Drug Administration for Esomeprazole Magnesium Delayed-Release Capsules, 20 mg (base) and 40 mg (base). Nexium(R) (Esomeprazole) is the second largest selling drug in the U.S. with total annual market sales of $5.5 billion (IMS -- MAT: December 2007).
Ranbaxy believes that it has a FTF (First to File) status on the drug, providing it with a potential 180 days marketing exclusivity, thereby offering a significant opportunity in the future.
Esomeprazole is indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis, to maintain symptom resolution and healing of erosive esophagitis and for treatment of heartburn and other symptoms associated with Gastroesophageal Reflux Disease (GERD).
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