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Generic Nexium Availability

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

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: 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: IVAX SUB TEVA PHARMS
    Approval date: January 26, 2015
    Strength(s): EQ 20MG BASE [AB], EQ 40MG BASE [AB]
  • Manufacturer: MYLAN PHARMS INC
    Approval date: August 2, 2015
    Strength(s): EQ 20MG BASE [AB]
  • Manufacturer: MYLAN PHARMS INC
    Approval date: August 3, 2015
    Strength(s): EQ 40MG BASE [AB]
  • Manufacturer: TORRENT PHARMS LTD
    Approval date: October 19, 2015
    Strength(s): EQ 20MG BASE [AB], EQ 40MG BASE [AB]

Note: No generic formulation of the following product is available.

  • esomeprazole magnesium - for suspension, delayed release;oral

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: About generic drugs.

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.

  • Omeprazole magnesium salt form
    Patent 5,900,424
    Issued: May 4, 1999
    Inventor(s): Kallstrom; Lars .ANG.ke & Nygren; Monica Annelie
    Assignee(s): Astra Aktiebolag
    A novel compound form of magnesium omeprazole useful in the manufacture of pharmaceutical formulations, the use of the product and the process for its production are described.
    Patent expiration dates:
    • November 4, 2016
      ✓ 
      Pediatric exclusivity
  • Omeprazole process and compositions thereof
    Patent 6,147,103
    Issued: November 14, 2000
    Inventor(s): Anousis; Nick & McManus; James W. & Banks; Benjamin Newton & Zhou; Lingwen
    Assignee(s): Merck & Co., Inc.
    The present invention describes an improved process for the preparation, isolation, and purification of the anti-ulcer agent omeprazole whereby the sulfide precursor pyrmetazole is reacted subsurfacely with exactly one molar equivalent of meta-chloroperoxybenzoic acid in methylene chloride or toluene solution; residual organic solvent is removed from the aqueous layer by vacuum distillation; crude product is obtained by reactive crystallization with an alkyl formate and seeding; and pure product is isolated by recrystallization in methanol-water containing aqueous NaOH by subsurface addition of aqueous acetic acid to pH 9.0, seeding, filtration, washing, and drying. Compositions of omeprazole containing no chromatographically detectable levels of residual non-alcoholic organic reaction solvent are also described.
    Patent expiration dates:
    • October 9, 2018
    • April 9, 2019
      ✓ 
      Pediatric exclusivity
  • Omeprazole process and compositions thereof
    Patent 6,166,213
    Issued: December 26, 2000
    Inventor(s): Anousis; Nick & McManus; James W. & Banks; Benjamin Newton & Zhou; Lingwen & Liu; Hui
    Assignee(s): Merck & Co., Inc.
    The present invention describes an improved process for the preparation, isolation, and purification of the anti-ulcer agent omeprazole whereby the sulfide precursor pyrmetazole is reacted subsurfacely with exactly one molar equivalent of meta-chloroperoxybenzoic acid in methylene chloride or toluene solution; residual organic solvent is removed from the aqueous layer by vacuum distillation; crude product is obtained by reactive crystallization with an alkyl formate and seeding; and pure product is isolated by recrystallization in methanol-water containing aqueous NaOH by subsurface addition of aqueous acetic acid to pH 9.0, seeding, filtration, washing, and drying. Compositions of omeprazole containing no chromatographically detectable levels of residual non-alcoholic organic reaction solvent are also described.
    Patent expiration dates:
    • October 9, 2018
    • April 9, 2019
      ✓ 
      Pediatric exclusivity
  • Omerazole process and compositions thereof
    Patent 6,191,148
    Issued: February 20, 2001
    Inventor(s): McManus; James W. & Anousis; Nick & Banks; Benjamin Newton & Liu; Hui & Zhou; Lingwen
    Assignee(s): Merck & Co., Inc.
    The present invention describes an improved process for the preparation, isolation, and purification of the anti-ulcer agent omeprazole whereby the sulfide precursor pyrmetazole is reacted subsurfacely with exactly one molar equivalent of meta-chloroperoxybenzoic acid in a chlorinated aliphatic hydrocarbon or aromatic hydrocarbon solvent, such as methylene chloride or toluene; residual organic solvent is removed from the aqueous layer by vacuum distillation; crude product is obtained by reactive crystallization with an alkyl formate or formic acid solution and seeding; and pure product is isolated by recrystallization in methanol-water containing aqueous NaOH by subsurface addition of aqueous acetic acid to pH 9.0, seeding, filtration, washing, and drying. Omeprazole and compositions of omeprazole containing no chromatographically detectable levels of residual non-alcoholic organic reaction solvent and diminished levels of alcoholic solvent are also described.
    Patent expiration dates:
    • October 9, 2018
    • April 9, 2019
      ✓ 
      Pediatric exclusivity
  • Form of S-omeprazole
    Patent 6,369,085
    Issued: April 9, 2002
    Inventor(s): Hanna; Cotton & Anders; Kronström & Anders; Mattson & Eva; Möller
    Assignee(s): AstraZeneca AB
    The present invention relates to a novel form of the (−)-enantiomer of 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)-methyl]sulfinyl]-1H-benzimidazole, i.e. S-omeprazole. More specifically, it relates to a novel form of the magnesium salt of the S-enantiomer of omeprazole trihydrate. The present invention also relates to processes for preparing such a form of the magnesium salt of S-omeprazole and pharmaceutical compositions containing it. Furthermore, the present invention also relates to new intermediates used in the process.
    Patent expiration dates:
    • May 25, 2018
      ✓ 
      Patent use: INFANT USE AGED 1 MONTH TO LESS THAN ONE YEAR, GERD AND EROSIVE ESOPHAGITIS
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • May 25, 2018
      ✓ 
      Patent use: TREATMENT OF GASTROESOPHAGEAL REFLUX DISEASE (GERD), RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER, H. PYLORI ERADICATION TO REDUCE THE RISK OF DUODENAL ULCER RECURRENCE
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • May 25, 2018
      ✓ 
      Patent use: PATHOLOGICAL HYPERSECRETORY CONDITIONS
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • May 25, 2018
      ✓ 
      Patent use: PEDIATRIC USE AGED 1-11 YEARS, GERD AND EROSIVE ESOPHAGITIS
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • May 25, 2018
      ✓ 
      Patent use: LONG-TERM TREATMENT OF PATHOLOGICAL HYPERSECRETORY CONDITIONS
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • November 25, 2018
      ✓ 
      Pediatric exclusivity
  • 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:
    • November 3, 2019
      ✓ 
      Patent use: INFANT USE AGED 1 MONTH TO LESS THAN ONE YEAR, GERD AND EROSIVE ESOPHAGITIS
      ✓ 
      Drug product
    • November 3, 2019
      ✓ 
      Patent use: TREATMENT OF GASTROESOPHAGEAL REFLUX DISEASE (GERD), RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER, H. PYLORI ERADICATION TO REDUCE THE RISK OF DUODENAL ULCER RECURRENCE
      ✓ 
      Drug product
    • November 3, 2019
      ✓ 
      Patent use: PATHOLOGICAL HYPERSECRETORY CONDITIONS
      ✓ 
      Drug product
    • November 3, 2019
      ✓ 
      Patent use: PEDIATRIC USE AGED 1-11 YEARS, GERD AND EROSIVE ESOPHAGITIS
      ✓ 
      Drug product
    • November 3, 2019
      ✓ 
      Patent use: TREATMENT OF GASTROESOPHAGEAL REFLEX DISEASE (GERD) AND ERADICATION OF H.PYLORI TO REDUCE RISK OF DUODENAL ULCER RECURRENCE
      ✓ 
      Drug product
    • November 3, 2019
      ✓ 
      Patent use: LONG-TERM TREATMENT OF PATHOLOGICAL HYPERSECRETORY CONDITIONS
      ✓ 
      Drug product
    • May 3, 2020
      ✓ 
      Pediatric exclusivity
  • Form of S-omeprazole
    Patent 7,411,070
    Issued: August 12, 2008
    Inventor(s): Cotton; Hanna & Kronström; Anders & Mattson; Anders & Möller; Eva
    Assignee(s): AstraZeneca AB
    The present invention relates to a novel form of the (−)-enantiomer of 5-methoxy-2[[(4-methoxy-3,5-dimethyl-2-pyridinyl)-methyl]sulfinyl]-1H-benzimidazole, i.e. S-omeprazole. More specifically, it relates to a novel form of the magnesium salt of the S-enantiomer of omeprazole trihydrate. The present invention also relates to processes for preparing such a form of the magnesium salt of S-omeprazole and pharmaceutical compositions containing it. Furthermore, the present invention also relates to new intermediates used in the process.
    Patent expiration dates:
    • May 25, 2018
      ✓ 
      Drug substance
    • November 25, 2018
      ✓ 
      Pediatric exclusivity
  • Form of S-omeprazole
    Patent 8,466,175
    Issued: June 18, 2013
    Assignee(s): AstraZeneca AB
    The present invention relates to a novel form of the (−)-enantiomer of 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)-methyl]sulfinyl]-1H-benzimidazole, i.e. S-omeprazole. More specifically, it relates to a novel form of the magnesium salt of the S-enantiomer of omeprazole trihydrate. The present invention also relates to processes for preparing such a form of the magnesium salt of S-omeprazole and pharmaceutical compositions containing it. Furthermore, the present invention also relates to new intermediates used in the process.
    Patent expiration dates:
    • May 25, 2018
      ✓ 
      Patent use: USE FOR TREATMENT OF HELICOBACTER INFECTIONS
    • November 25, 2018
      ✓ 
      Pediatric exclusivity
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More about Nexium (esomeprazole)

Consumer resources

Other brands: Nexium 24HR

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Glossary

TermDefinition
Drug PatentA 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 ExclusivityExclusivity 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.
RLDA 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.
ABProducts 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.

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