Acid-suppressive effects of generic omeprazole: Comparison of three brands of generic omeprazole with original omeprazole

Abstract

Acid-suppressive effects of some brands of generic omeprazole are not the same as original omeprazole. These differences might be reflected in clinical outcomes.

Intragastric acidity during administration of generic omeprazole or esomeprazole - a randomised, two-way crossover study including CYP2C19 genotyping

“…Esomeprazole 20 mg daily has proven effective for maintenance therapy of erosive GERD, 14,15 for on-demand therapy in non-erosive GERD 25,26 and for prevention of gastroduodenal ulcers in patients with nonsteroidal anti-inflammatory drugs. 27 As other intragastric pH studies and pharmaceutical studies have suggested significant differences between different generic omeprazole products, 17,18 the question remains whether generic omeprazole can provide a similar clinical efficacy as other original PPI brands. Although the results of our intragastric pH study can not be directly transferred to clinical outcomes, we speculate that the generic omeprazole used in our study with a daily dose of 20 mg might offer a similar clinical benefit in the treatment of acid-related gastroduodenal disorders as other original brand PPIs.…”

“…A randomised study in Japanese healthy subjects demonstrated significant differences in intragastric acid control between one original and two generic omeprazole brands. 17 Finally, a comparative study of 25 non-Astra authorised omeprazole products suggests significant pharmaceutical differences between various products after storage under forced conditions. 18 Due to differences in the enzymatic hepatic metabolism, the racemic omeprazole and the s-isomer esomeprazole differ in their pharmacokinetic and pharmacodynamic profile.…”

Tyrosine Kinase Inhibitors and Proton Pump Inhibitors: An Evaluation of Treatment Options

“…Moreover, there is also large variability in the onset of action between different PPIs and between brand and generic formulas (inter-PPI variability) [16, 17, 28, 29]. Due to these factors, in theory, the delayed onset of action may be significantly shorter.…”

Comparative pharmacokinetic and pharmacodynamic evaluation of branded and generic formulations of meloxicam in healthy male volunteers

“…Moreover, some authors3–5 argued that switching from brand antiepileptics to generic copies might result in an increased risk of therapeutic failure (breakthrough seizures) or adverse reactions. Other examples of treatment failure, with marketed antibiotic,6 anticoagulant,7 proton-pump inhibitor,8,9 antiarrhythmic,10 or antidepressant11 generic products, have also been published. Thus, the validity of current criteria for assessing interchangeability of generic and branded drugs is being questioned, at least in some instances, and it is becoming evident that inadequate programs for postmarketing quality control of medicinal products might increase the risk of therapeutic failures and/or safety concerns in patients 12.…”