Can esomeprazole strontium be substituted for Nexium® (esomeprazole magnesium)?
No. Although esomeprazole strontium has the same active moiety as Nexium®, it is not AB-rated and, therefore, not substitutable. It must be prescribed by a health care provider. Esomeprazole strontium contains a different salt form of esomeprazole than Nexium®.
Esomeprazole strontium is in the same therapeutic class as other proton pump inhibitors (PPIs), but it is not AB–rated to any esomeprazole products on the market aside from the branded esomeprazole strontium that was also launched by Amneal Pharmaceuticals in December 2013. It requires a prescription or authorization from the prescribing physician to dispense in place of a previously prescribed product for the same indication. Pharmacists should reference their specific state regulations for switching products within the same therapeutic class if they feel esomeprazole strontium would benefit an adult patient for whom another product was prescribed.
Is esomeprazole strontium a generic (AB-rated) to any product?
Esomeprazole strontium is the authorized generic to its branded counterpart, which has the same name (Esomeprazole strontium delayed-release capsules 49.3 mg) launched by Amneal in December 2013. Esomeprazole strontium is not AB–rated to any esomeprazole products on the market other than to its branded counterpart.
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12/17/2013 – Amneal launched the 505(b)2 product Esomeprazole strontium delayed-release capsules, 49.3 mg (NDC# 53746-0957-03)
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1/6/2014 – Amneal launched the generic to our brand esomeprazole strontium (the 505(b)(2) product described above) labeled under the same name, Esomeprazole strontium delayed-release capsules, 49.3mg (NDC# 65162-0957-03)
Equivalency
Answers to Frequently Asked Questions
Why isn’t esomeprazole strontium a generic for Nexium®?
Esomeprazole strontium was approved by the U.S. FDA as an NDA (New Drug Application) under section 505(b)(2) of the Federal Food, Drug, and Cosmetics Act. A 505(b)(2) application allows for a certain degree of variation from an approved product (reference drug) while still relying on some of the data from that approved product. However, to be considered a generic equivalent for the reference drug, it must retain a certain “sameness” to it. Because it uses a different salt, esomeprazole strontium did not retain enough “sameness” to Nexium® and therefore could not be approved as a generic.
Approval of the esomeprazole strontium application still relied on the FDA's previous findings of safety and/or effectiveness for Nexium® (esomeprazole magnesium). This is why that approved drug is referenced frequently in the full prescribing information for esomeprazole strontium.
For more information on 505(b)(2) product approvals, visit www.FDA.gov and search for 505(b)(2).
Is esomeprazole strontium the same as Nexium®?
No. It is not the same product. Esomeprazole strontium is approved for the same indications in adults and based on the same safety and efficacy data as Nexium® for adults. However, esomeprazole strontium is not approved for use in patients under the age of 18.
Please see the Full Prescribing Information and Important Safety Information for esomeprazole strontium.
What is the efficacy of esomeprazole strontium compared to esomeprazole magnesium? Is it the same?
Esomeprazole Strontium is a pharmaceutical alternative to Nexium®. It contains the same active moiety (esomeprazole) in a different salt form as found in the branded proton-pump inhibitor Nexium® (esomeprazole magnesium) and is a new option for adult patients for the short term treatment of gastroesophageal reflux disease (GERD).