Ranbaxy Laboratories

Drug Store News, March 3, 2008 by Jim Frederick

Ranbaxy Laboratories has received tentative approval from the Food and Drug Administration for esomeprazole magnesium delayed-release capsules, 20 mg and 40 mg. This is the genetic version of AstraZeneca's drug, Nexium.

Nexium is indicated for the short-term treatment (four to eight 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.

Ranbaxy believes that it has a first-to-file status on the drug, providing it with a potential 180 days marketing exclusivity.

Nexium is the second-largest selling drug in the United States, with annual market sales of $5.5 billion, reports IMS Health.