Nexium® (esomeprazole) — First-time Generic
• On January 26, 2015, the FDA announced the first-time generic approval of AstraZeneca’s Nexium (esomeprazole) delayed-release (DR) capsules.
• Ivax Pharmaceuticals, a subsidiary of Teva Pharmaceuticals USA, has gained approval to market esomeprazole 20 mg and 40 mg DR capsules.
— Generic esomeprazole DR capsules are estimated to launch in mid February 2015.
• Esomeprazole is indicated for the following:
— Short-term treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD)
— Short-term treatment in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis
— Maintain symptom resolution and healing of erosive esophagitis
— Reduction in the occurrence of gastric ulcers associated with continuous nonsteroidal anti- inflammatory drug (NSAID) therapy in patients at risk for developing gastric ulcers
— In combination with amoxicillin and clarithromycin, for the treatment of patients with H. pylori infection and duodenal ulcer disease to eradicate H. pylori
— Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome
• Nexium is also available in injection and DR oral suspension formulations. Esomeprazole injection is available generically.
• Esomeprazole is a proton pump inhibitor (PPI) that reduces the amount of acid in the stomach. Other marketed PPIs include Aciphex® (rabeprazole), Dexilant® (dexlansoprazole), esomeprazole strontium, Prevacid® (lansoprazole), Prilosec® (omeprazole), and Protonix® (pantoprazole).
— Rabeprazole, lansoprazole, omeprazole, and pantoprazole are available generically.
• Generic esomeprazole capsules will be dispensed with a patient Medication Guide that provides important information about the medication’s use and risks. The most serious risks are stomach problems, including severe diarrhea, and a warning that people who take multiple daily doses of PPIs for a long period of time may have an increased risk of bone fractures.
• In 2013, U.S. sales for Nexium was $5.97 billion.
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