Pharmaceutical Business review

Ranbaxy receives tentative approval for ulcer drug

Esomeprazole is a generic equivalent to Nexium which 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 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.