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Generic Nexium Availability

See also: Generic Nexium IV

Nexium is a brand name of esomeprazole, approved by the FDA in the following formulation(s):

NEXIUM (esomeprazole magnesium - capsule, delayed rel pellets;oral)

  • Manufacturer: ASTRAZENECA PHARMS
    Approval date: February 20, 2001
    Strength(s): EQ 20MG BASE [RLD] [AB], EQ 40MG BASE [RLD] [AB]

NEXIUM (esomeprazole magnesium - for suspension, delayed release;oral)

  • Manufacturer: ASTRAZENECA PHARMS
    Approval date: October 20, 2006
    Strength(s): EQ 20MG BASE/PACKET [RLD] [AB], EQ 40MG BASE/PACKET [RLD] [AB]
  • Manufacturer: ASTRAZENECA PHARMS
    Approval date: February 27, 2008
    Strength(s): EQ 10MG BASE/PACKET [RLD] [AB]
  • Manufacturer: ASTRAZENECA PHARMS
    Approval date: December 15, 2011
    Strength(s): EQ 2.5MG BASE/PACKET [RLD], EQ 5MG BASE/PACKET [RLD]

Has a generic version of Nexium been approved?

A generic version of Nexium has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Nexium and have been approved by the FDA:

esomeprazole magnesium capsule, delayed rel pellets;oral

  • Manufacturer: ALKEM LABS LTD
    Approval date: October 20, 2017
    Strength(s): EQ 20MG BASE [AB], EQ 40MG BASE [AB]
  • Manufacturer: AUROBINDO PHARMA LTD
    Approval date: April 21, 2016
    Strength(s): EQ 20MG BASE [AB], EQ 40MG BASE [AB]
  • Manufacturer: DR REDDYS LABS LTD
    Approval date: September 25, 2015
    Strength(s): EQ 20MG BASE [AB], EQ 40MG BASE [AB]
  • Manufacturer: GLENMARK PHARMS
    Approval date: May 10, 2019
    Strength(s): EQ 20MG BASE [AB], EQ 40MG BASE [AB]
  • Manufacturer: HETERO LABS LTD III
    Approval date: September 21, 2015
    Strength(s): EQ 20MG BASE [AB], EQ 40MG BASE [AB]
  • Manufacturer: HETERO LABS LTD III
    Approval date: June 2, 2020
    Strength(s): EQ 20MG BASE [AB], EQ 40MG BASE [AB]
  • Manufacturer: IVAX SUB TEVA PHARMS
    Approval date: January 26, 2015
    Strength(s): EQ 20MG BASE [AB], EQ 40MG BASE [AB]
  • Manufacturer: LANNETT CO INC
    Approval date: September 1, 2017
    Strength(s): EQ 20MG BASE [AB], EQ 40MG BASE [AB]
  • Manufacturer: MYLAN
    Approval date: August 2, 2015
    Strength(s): EQ 20MG BASE [AB]
  • Manufacturer: MYLAN
    Approval date: August 3, 2015
    Strength(s): EQ 40MG BASE [AB]
  • Manufacturer: SUN PHARM
    Approval date: April 30, 2018
    Strength(s): EQ 20MG BASE [AB], EQ 40MG BASE [AB]
  • Manufacturer: TORRENT
    Approval date: October 19, 2015
    Strength(s): EQ 20MG BASE [AB], EQ 40MG BASE [AB]
  • Manufacturer: ZYDUS PHARMS
    Approval date: May 22, 2019
    Strength(s): EQ 20MG BASE [AB], EQ 40MG BASE [AB]

esomeprazole magnesium for suspension, delayed release;oral

  • Manufacturer: CIPLA
    Approval date: March 23, 2020
    Strength(s): EQ 10MG BASE/PACKET [AB], EQ 20MG BASE/PACKET [AB], EQ 40MG BASE/PACKET [AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Nexium. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: Generic Drug FAQs.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

  • Pharmaceutical formulation comprising omeprazole
    Patent 6,428,810
    Issued: August 6, 2002
    Inventor(s): Pontus; Bergstrand & Peter; Wang
    Assignee(s): AstraZeneca AB

    An enteric coated oral pharmaceutical formulation comprising as active ingredient a compound selected from the group of omeprazole, an alkaline salt of omeprazole, one of the single enantiomers of omeprazole and an alkaline salt of one of the single enantiomers of omeprazole, wherein the formulation comprises a core material that comprises the active ingredient and optionally an alkaline reacting compound, the active ingredient is in admixture with a pharmaceutically acceptable excipient, such as for instance a binding agent, and on said core material a separating layer and an enteric coating layer. A hydroxypropyl cellulose (HPC) with a specific cloud point is used in the manufacture of the claimed pharmaceutical formulations. Furthermore, the application describes the processes for their preparation and the use of the claimed formulations in medicine.

    Patent expiration dates:

    • May 3, 2020
      ✓ 
      Pediatric exclusivity

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Glossary

Term Definition
Drug Patent A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug Exclusivity Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLD A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
AB Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (i.e., identical active ingredients(s), dosage form, and route(s) of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (i.e., AB1, AB2, AB3, etc.). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.