There is on-going development of generic EU CTD Dossier of Esomeprazole, enteric coated tablets, 20/40 mg.
Development of this pharmaceutical is carried out according to EU-requirements in country without patent protection or with Bolar-provisions. There will be no sales in those countries where this offer would constitute an infringement of third parties intellectual proprietary rights.
Esomeprazole is a proton pump inhibitor (brand names Sompraz, Zoleri, Nexium, Lucen, Esopral; Axagon in Italy, Nexiam in Belgium) developed and marketed by AstraZeneca which is used in the treatment of dyspepsia, peptic ulcer disease (PUD), gastroesophageal reflux disease (GORD/GERD) and Zollinger-Ellison syndrome. Esomeprazole is the S-enantiomer of omeprazole (marketed as Losec/Prilosec), and AstraZeneca claims improved efficacy of this single enantiomer product over the racemic mixture of omeprazole. However, this greater efficacy has been disputed, with some[who?] claiming it offers no benefit from its older form.
More details at: http://www.rxlist.com/nexium-drug.htm.
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