Generic Nexium IV Availability

See also: Generic Nexium

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

NEXIUM IV (esomeprazole sodium - injectable;intravenous)

  • Manufacturer: ASTRAZENECA
    Approval date: March 31, 2005
    Strength(s): EQ 20MG BASE/VIAL [RLD] [AP], EQ 40MG BASE/VIAL [RLD] [AP]

Has a generic version of Nexium IV been approved?

A generic version of Nexium IV 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 IV and have been approved by the FDA:

esomeprazole sodium injectable;intravenous

  • Manufacturer: SUN PHARMA GLOBAL
    Approval date: March 18, 2013
    Strength(s): EQ 20MG BASE/VIAL [AP], EQ 40MG BASE/VIAL [AP]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Nexium IV. 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.

  • Method for the treatment of gastric acid-related diseases and production of medication using (-) enantiomer of omeprazole
    Patent 5,877,192
    Issued: March 2, 1999
    Inventor(s): Lindberg; Per & Weidolf; Lars
    Assignee(s): Astra Aktiebolag
    A method for treatment of gastric acid related diseases by inhibition of gastric acid secretion comprising administering to a mammal in need of treatment a therapeutically effective amount of the (-)-enantiomer of 5-methoxy-2-››(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl!sulfinyl!-1H-benz imidazole or a pharmaceutically acceptable salt thereof, so as to effect decreased interindividual variation in plasma levels upon administration. The use of the (-)-enantiomer of omeprazole to receive increased average plasma levels (AUC) upon administration of the same doses of the (-)-enantiomer of omeprazole compared to those of racemic omeprazole is also claimed, as well as an improved antisecretory effect and a better clinical effect.
    Patent expiration dates:
    • May 27, 2014
      ✓ 
      Patent use: THE SHORT TERM TREATMENT (UP TO 10 DAYS) IN PTS HAVING GASTROESOPHAGEAL REFLUX DISEASE (GERD) AS AN ALTERNATIVE TO ORAL THERAPY IN PTS WHEN THERAPY WITH NEXIUM CAPSULES IS NOT POSSIBLE OR APPROPRIATE
    • May 27, 2014
      ✓ 
      Patent use: RISK REDUCTION OF REBLEEDING IN PTS FOLLOWING THERAPEUTIC ENDOSCOPY FOR ACUTE BLEEDING GASTRIC OR DUODENAL ULCERS IN ADULTS.
    • November 27, 2014
      ✓ 
      Pediatric exclusivity
  • Compounds
    Patent 6,143,771
    Issued: November 7, 2000
    Inventor(s): Lindberg; Per Lennart & von Unge; Sverker
    Assignee(s): AstraZeneca AB
    The novel optically pure compounds Na.sup.+, Mg.sup.2+, Li.sup.+, K.sup.+, Ca.sup.2+ and N.sup.+ (R).sub.4 salts of (+)-5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H- benzimidazole or (-)-5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H- benzimidazole, in particular sodium and magnesium salt form thereof, where R is an alkyl with 1-4 carbon atoms, processes for the preparation thereof and pharmaceutical preparations containing the compounds as active ingredients, as well as the use of the compounds in pharmaceutical preparations and intermediates obtained by preparing the compounds.
    Patent expiration dates:
    • May 27, 2015
      ✓ 
      Patent use: THE SHORT TERM TREATMENT (UP TO 10 DAYS) IN PTS HAVING GASTROESOPHAGEAL REFLUX DISEASE (GERD) AS AN ALTERNATIVE TO ORAL THERAPY IN PTS WHEN THERAPY WITH NEXIUM CAPSULES IS NOT POSSIBLE OR APPROPRIATE
      ✓ 
      Drug product
    • May 27, 2015
      ✓ 
      Patent use: RISK REDUCTION OF REBLEEDING IN PTS FOLLOWING THERAPEUTIC ENDOSCOPY FOR ACUTE BLEEDING GASTRIC OR DUODENAL ULCERS IN ADULTS.
      ✓ 
      Drug product

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:
    • March 4, 2017 - 80 MG DOSING REGIMEN FOR THE RISK REDUCTION OF REBLEEDING OF GASTRIC AND DUODENAL ULCERS IN THE FIRST 72 HOURS FOLLOWING THERAPEUTIC ENDOSCOPY IN ADULTS
    • March 4, 2017 - RISK REDUCTION OF REBLEEDING OF GASTRIC OR DUODENAL ULCERS FOLLOWING THERAPEUTIC ENDOSCOPY IN ADULTS

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.
APInjectable aqueous solutions and, in certain instances, intravenous non-aqueous solutions. It should be noted that even though injectable (parenteral) products under a specific listing may be evaluated as therapeutically equivalent, there may be important differences among the products in the general category, Injectable; Injection. For example, some injectable products that are rated therapeutically equivalent are labeled for different routes of administration. In addition, some products evaluated as therapeutically equivalent may have different preservatives or no preservatives at all. Injectable products available as dry powders for reconstitution, concentrated sterile solutions for dilution, or sterile solutions ready for injection are pharmaceutical alternative drug products. They are not rated as therapeutically equivalent (AP) to each other even if these pharmaceutical alternative drug products are designed to produce the same concentration prior to injection and are similarly labeled. Consistent with accepted professional practice, it is the responsibility of the prescriber, dispenser, or individual administering the product to be familiar with a product's labeling to assure that it is given only by the route(s) of administration stated in the labeling.
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