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Generic Duexis Availability

Last updated on May 11, 2022.

Duexis is a brand name of famotidine/ibuprofen, approved by the FDA in the following formulation(s):

DUEXIS (famotidine; ibuprofen - tablet;oral)

  • Manufacturer: HORIZON
    Approval date: April 23, 2011
    Strength(s): 26.6MG;800MG [RLD] [AB]

Has a generic version of Duexis been approved?

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

IBUPROFEN AND FAMOTIDINE (famotidine; ibuprofen tablet;oral)

  • Manufacturer: ALKEM LABS LTD
    Approval date: August 3, 2021
    Strength(s): 26.6MG;800MG [AB]
  • Manufacturer: TEVA PHARMS USA
    Approval date: October 29, 2021
    Strength(s): 26.6MG;800MG [AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Duexis. 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 FAQ.

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.

  • Methods and medicaments for administration of ibuprofen
    Patent 8,067,451
    Issued: November 29, 2011
    Inventor(s): Tidmarsh; George & Golombik; Barry L. & Sharma; Puneet
    Assignee(s): Horizon Pharma USA, Inc.

    A method for administration of ibuprofen to a subject in need of ibuprofen treatment is provided, in which an oral dosage form comprising a therapeutically effective amount of ibuprofen and a therapeutically effective amount of famotidine is administered three times per day.

    Patent expiration dates:

    • July 18, 2026
      ✓ 
      Patent use: RELIEF OF SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS AND OSTEOARTHRITIS AND TO DECREASE RISK OF DEVELOPING UPPER GASTROINTESTINAL ULCERS IN PATIENTS WHO ARE TAKING IBUPROFEN FOR THOSE INDICATIONS
      ✓ 
      Drug product
  • Stable compositions of famotidine and ibuprofen
    Patent 8,309,127
    Issued: November 13, 2012
    Inventor(s): Xu; Jerry & Tidmarsh; George F.
    Assignee(s): Horizon Pharma USA, Inc.

    Stable pharmaceutical compositions of famotidine and ibuprofen in a single unit dosage form are disclosed herein. The compositions comprise a famotidine core having a reduced or minimal surface area surrounded by a layer of ibuprofen. In some embodiments, the ibuprofen is in direct physical contact with the famotidine.

    Patent expiration dates:

    • July 18, 2026
      ✓ 
      Drug product
  • Stable compositions of famotidine and ibuprofen
    Patent 8,318,202
    Issued: November 27, 2012
    Inventor(s): Xu; Jerry & Tidmarsh; George F.
    Assignee(s): Horizon Pharma USA, Inc.

    Stable pharmaceutical compositions of famotidine and ibuprofen in a single unit dosage form are disclosed herein. The compositions comprise a famotidine core having a reduced or minimal surface area surrounded by a layer of ibuprofen. In some embodiments, the ibuprofen is in direct physical contact with the famotidine.

    Patent expiration dates:

    • July 18, 2026
      ✓ 
      Drug product
  • Stable compositions of famotidine and ibuprofen
    Patent 8,449,910
    Issued: May 28, 2013
    Assignee(s): Horizon Pharma USA, Inc.

    Stable pharmaceutical compositions of famotidine and ibuprofen in a single unit dosage form are disclosed herein. The compositions comprise a famotidine core having a reduced or minimal surface area surrounded by a layer of ibuprofen. In some embodiments, the ibuprofen is in direct physical contact with the famotidine.

    Patent expiration dates:

    • July 18, 2026
      ✓ 
      Drug product
  • Stable compositions of famotidine and ibuprofen
    Patent 8,501,228
    Issued: August 6, 2013
    Assignee(s): Horizon Pharma USA, Inc.

    Stable pharmaceutical compositions of famotidine and ibuprofen in a single unit dosage form are disclosed herein. The compositions comprise a famotidine core having a reduced or minimal surface area surrounded by a layer of ibuprofen. In some embodiments, the ibuprofen is in direct physical contact with the famotidine.

    Patent expiration dates:

    • July 18, 2026
      ✓ 
      Patent use: RELIEF OF SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS AND OSTEOARTHRITIS AND TO DECREASE RISK OF DEVELOPING UPPER GASTROINTESTINAL ULCERS IN PATIENTS WHO ARE TAKING IBUPROFEN FOR THOSE INDICATIONS

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 (e.g. identical active ingredients, dosage form, and routes 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 (e.g. AB1, AB2, AB7). 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.

Further information

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

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