Nexium® () — 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 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® (), Dexilant® (dexlansoprazole), esomeprazole strontium, Prevacid® (), Prilosec® (), and Protonix® ().

— 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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