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Generic Amrix Availability

Last updated on May 11, 2023.

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

AMRIX (cyclobenzaprine hydrochloride - capsule, extended release;oral)

  • Manufacturer: TEVA PHARMS INTL
    Approval date: February 1, 2007
    Strength(s): 15MG [RLD] [AB], 30MG [RLD] [AB]

Has a generic version of Amrix been approved?

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

cyclobenzaprine hydrochloride capsule, extended release;oral

  • Manufacturer: TWI PHARMS INC
    Approval date: January 31, 2013
    Strength(s): 15MG [AB], 30MG [AB]

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

  • Modified release dosage forms of skeletal muscle relaxants
    Patent 7,387,793
    Issued: June 17, 2008
    Inventor(s): Venkatesh; Gopi & Clevenger; James M.
    Assignee(s): Eurand, Inc.

    A unit dosage form, such as a capsule or the like, for delivering a skeletal muscle relaxant, such as cyclobenzaprine hydrochloride, into the body in an extended or sustained release fashion comprising one or more populations of drug-containing particles (beads, pellets, granules, etc.) is disclosed. At least one bead population exhibits a pre-designed sustained release profile. Such a drug delivery system is designed for once-daily oral administration to maintain an adequate plasma concentration—time profile, thereby providing relief of muscle spasm associated with painful musculoskeletal conditions over a 24 hour period.

    Patent expiration dates:

    • February 26, 2025
      ✓ 
      Drug product
  • Modified release dosage forms of skeletal muscle relaxants
    Patent 7,544,372
    Issued: June 9, 2009
    Inventor(s): Venkatesh; Gopi & Clevenger; James M.
    Assignee(s): Eurand, Inc.

    A unit dosage form, such as a capsule or the like, for delivering a skeletal muscle relaxant, such as cyclobenzaprine hydrochloride, into the body in an extended or sustained release fashion comprising one or more populations of drug-containing particles (beads, pellets, granules, etc.) is disclosed. At least one bead population exhibits a pre-designed sustained release profile. Such a drug delivery system is designed for once-daily oral administration to maintain an adequate plasma concentration-time profile, thereby providing relief of muscle spasm associated with painful musculoskeletal conditions over a 24 hour period.

    Patent expiration dates:

    • November 14, 2023
      ✓ 
      Patent use: RELIEF OF MUSCLE SPASM
  • Modified release dosage forms of skeletal muscle relaxants
    Patent 7,790,199
    Issued: September 7, 2010
    Inventor(s): Venkatesh; Gopi & Clevenger; James M.
    Assignee(s): Eurand, Inc.

    A unit dosage form, such as a capsule or the like, for delivering a skeletal muscle relaxant, such as cyclobenzaprine hydrochloride, into the body in an extended or sustained release fashion comprising one or more populations of drug-containing particles (beads, pellets, granules, etc.) is disclosed. At least one bead population exhibits a pre-designed sustained release profile. Such a drug delivery system is designed for once-daily oral administration to maintain an adequate plasma concentration—time profile, thereby providing relief of muscle spasm associated with painful musculoskeletal conditions over a 24 hour period.

    Patent expiration dates:

    • November 14, 2023
      ✓ 
      Drug product
  • Modified release dosage forms of skeletal muscle relaxants
    Patent 7,820,203
    Issued: October 26, 2010
    Inventor(s): Venkatesh; Gopi & Clevenger; James M.
    Assignee(s): Eurand, Inc.

    A unit dosage form, such as a capsule or the like, for delivering a skeletal muscle relaxant, such as cyclobenzaprine hydrochloride, into the body in an extended or sustained release fashion comprising one or more populations of drug-containing particles (beads, pellets, granules, etc.) is disclosed. At least one bead population exhibits a pre-designed sustained release profile. Such a drug delivery system is designed for once-daily oral administration to maintain an adequate plasma concentration—time profile, thereby providing relief of muscle spasm associated with painful musculoskeletal conditions over a 24 hour period.

    Patent expiration dates:

    • November 14, 2023
      ✓ 
      Drug product
  • Modified release dosage forms of skeletal muscle relaxants
    Patent 7,829,121
    Issued: November 9, 2010
    Inventor(s): Venkatesh; Gopi & Clevenger; James M.
    Assignee(s): Eurand Inc.

    A unit dosage form, such as a capsule or the like, for delivering a skeletal muscle relaxant, such as cyclobenzaprine hydrochloride, into the body in an extended or sustained release fashion comprising one or more populations of drug-containing particles (beads, pellets, granules, etc.) is disclosed. At least one bead population exhibits a pre-designed sustained release profile. Such a drug delivery system is designed for once-daily oral administration to maintain an adequate plasma concentration—time profile, thereby providing relief of muscle spasm associated with painful musculoskeletal conditions over a 24 hour period.

    Patent expiration dates:

    • November 14, 2023
      ✓ 
      Patent use: RELIEF OF MUSCLE SPASM
  • Modified release dosage forms of skeletal muscle relaxants
    Patent 8,877,245
    Issued: November 4, 2014
    Assignee(s): Aptalis Pharmatech, Inc.

    A unit dosage form, such as a capsule or the like, for delivering a skeletal muscle relaxant, such as cyclobenzaprine hydrochloride, into the body in an extended or sustained release fashion comprising one or more populations of drug-containing particles (beads, pellets, granules, etc.) is disclosed. At least one bead population exhibits a pre-designed sustained release profile. Such a drug delivery system is designed for once—daily oral administration to maintain an adequate plasma concentration—time profile, thereby providing relief of muscle spasm associated with painful musculoskeletal conditions over a 24 hour period.

    Patent expiration dates:

    • November 14, 2023
      ✓ 
      Patent use: RELIEF OF MUSCLE SPASM
  • Modified release dosage forms of skeletal muscle relaxants
    Patent 9,375,410
    Issued: June 28, 2016
    Assignee(s): ADARE PHARMACEUTICALS, INC.

    A unit dosage form, such as a capsule or the like, for delivering a skeletal muscle relaxant, such as cyclobenzaprine hydrochloride, into the body in an extended or sustained release fashion comprising one or more populations of drug-containing particles (beads, pellets, granules, etc.) is disclosed. At least one bead population exhibits a pre-designed sustained release profile. Such a drug delivery system is designed for once-daily oral administration to maintain an adequate plasma concentration-time profile, thereby providing relief of muscle spasm associated with painful musculoskeletal conditions over a 24 hour period.

    Patent expiration dates:

    • November 14, 2023
      ✓ 
      Patent use: RELIEF OF MUSCLE SPASM
  • Modified release dosage forms of skeletal muscle relaxants
    Patent 9,399,025
    Issued: July 26, 2016
    Assignee(s): ADARE PHARMACEUTICALS, INC.

    A unit dosage form, such as a capsule or the like, for delivering a skeletal muscle relaxant, such as cyclobenzaprine hydrochloride, into the body in an extended or sustained release fashion comprising one or more populations of drug-containing particles (beads, pellets, granules, etc.) is disclosed. At least one bead population exhibits a pre-designed sustained release profile. Such a drug delivery system is designed for once-daily oral administration to maintain an adequate plasma concentration—time profile, thereby providing relief of muscle spasm associated with painful musculoskeletal conditions over a 24 hour period.

    Patent expiration dates:

    • November 14, 2023
      ✓ 
      Patent use: RELIEF OF MUSCLE SPASM
      ✓ 
      Drug product

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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