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Generic Coreg CR Availability

Last updated on Nov 7, 2023.

See also: Generic Coreg

Coreg CR is a brand name of carvedilol, approved by the FDA in the following formulation(s):

COREG CR (carvedilol phosphate - capsule, extended release;oral)

  • Manufacturer: WOODWARD
    Approval date: October 20, 2006
    Strength(s): 10MG [RLD] [AB], 20MG [RLD] [AB], 40MG [RLD] [AB], 80MG [RLD] [AB]

Has a generic version of Coreg CR been approved?

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

carvedilol phosphate capsule, extended release;oral

  • Manufacturer: IMPAX LABS INC
    Approval date: May 7, 2018
    Strength(s): 10MG [AB], 20MG [AB], 40MG [AB], 80MG [AB]
  • Manufacturer: SUN PHARM INDUSTRIES
    Approval date: October 25, 2017
    Strength(s): 10MG [AB], 20MG [AB], 40MG [AB], 80MG [AB]

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

  • Patent 7,268,156
    Issued: November 30, -0001

    Patent expiration dates:

    • June 27, 2023
      ✓ 
      Patent use: TREATMENT OF HYPERTENSION
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • June 27, 2023
      ✓ 
      Patent use: TREATMENT OF CONGESTIVE HEART FAILURE
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Patent 7268156*PED
    Issued: November 30, -0001

    Patent expiration dates:

    • December 27, 2023
      ✓ 
      Pediatric exclusivity
  • Microparticulate oral galenical form for the delayed and controlled release of pharmaceutical active principles
    Patent 8,101,209
    Issued: January 24, 2012
    Inventor(s): Legrand Valérie & Castan Catherine & Meyrueix Rémi & Soula Gérard
    Assignee(s): Flamel Technologies

    The invention relates to a microparticulate system for the delayed and controlled release of active principles (AP) whose absorption window in vivo is essentially limited to the upper parts of the gastrointestinal tract, this system being intended for oral administration. The object of the invention is to provide a system ensuring that the AP is released with certainty by means of a dual mechanism of “time-dependent” and “pH-dependent” release. To achieve this object, the invention proposes a multimicrocapsular oral galenical form which is designed so as to guarantee therapeutic efficacy, and in which the release of the AP is governed by a dual release triggering mechanism that is “time-triggering” and “pH-triggering”. This system comprises of microcapsules (200 to 600 μm) comprising a core of AP coated with a film (maximum 40% by weight) comprising a hydrophilic polymer A (Eudragit® L) and a hydrophobic compound B (vegetable wax, melting point=40-90° C.), B/A being between 0.2 and 1.5. These microcapsules have a dissolution behavior in vitro such that, at a constant pH of 1.4, a latency phase of between 1 and 5 hours is observed, followed by a release of the AP, and such that the change from pH 1.4 to pH 6.8 results in a release of the AP without a latency period in vitro.

    Patent expiration dates:

    • September 11, 2025
      ✓ 
      Drug product
  • Microparticulate oral galenical form for the delayed and controlled release of pharmaceutical active principles
    Patent 8101209*PED
    Issued: January 24, 2012
    Inventor(s): Legrand Valérie & Castan Catherine & Meyrueix Rémi & Soula Gérard
    Assignee(s): Flamel Technologies

    The invention relates to a microparticulate system for the delayed and controlled release of active principles (AP) whose absorption window in vivo is essentially limited to the upper parts of the gastrointestinal tract, this system being intended for oral administration. The object of the invention is to provide a system ensuring that the AP is released with certainty by means of a dual mechanism of “time-dependent” and “pH-dependent” release. To achieve this object, the invention proposes a multimicrocapsular oral galenical form which is designed so as to guarantee therapeutic efficacy, and in which the release of the AP is governed by a dual release triggering mechanism that is “time-triggering” and “pH-triggering”. This system comprises of microcapsules (200 to 600 μm) comprising a core of AP coated with a film (maximum 40% by weight) comprising a hydrophilic polymer A (Eudragit® L) and a hydrophobic compound B (vegetable wax, melting point=40-90° C.), B/A being between 0.2 and 1.5. These microcapsules have a dissolution behavior in vitro such that, at a constant pH of 1.4, a latency phase of between 1 and 5 hours is observed, followed by a release of the AP, and such that the change from pH 1.4 to pH 6.8 results in a release of the AP without a latency period in vitro.

    Patent expiration dates:

    • March 11, 2026
      ✓ 
      Pediatric exclusivity

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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