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Generic Suboxone Availability

Suboxone is a brand name of buprenorphine/naloxone, approved by the FDA in the following formulation(s):

SUBOXONE (buprenorphine hydrochloride; naloxone hydrochloride - film;buccal, sublingual)

  • Manufacturer: INDIVIOR INC
    Approval date: August 30, 2010
    Strength(s): EQ 2MG BASE;EQ 0.5MG BASE [RLD] [AB], EQ 8MG BASE;EQ 2MG BASE [RLD] [AB]
  • Manufacturer: INDIVIOR INC
    Approval date: August 10, 2012
    Strength(s): EQ 4MG BASE;EQ 1MG BASE [RLD] [AB], EQ 12MG BASE;EQ 3MG BASE [RLD] [AB]

SUBOXONE (buprenorphine hydrochloride; naloxone hydrochloride - tablet;sublingual)

  • Manufacturer: INDIVIOR INC
    Approval date: October 8, 2002
    Strength(s): EQ 2MG BASE;EQ 0.5MG BASE (discontinued) [RLD] [AB], EQ 8MG BASE;EQ 2MG BASE (discontinued) [RLD] [AB]

Has a generic version of Suboxone been approved?

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

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (buprenorphine hydrochloride; naloxone hydrochloride film;buccal, sublingual)

  • Manufacturer: ALVOGEN PINE BROOK
    Approval date: January 24, 2019
    Strength(s): EQ 2MG BASE;EQ 0.5MG BASE [AB], EQ 4MG BASE;EQ 1MG BASE [AB], EQ 8MG BASE;EQ 2MG BASE [AB], EQ 12MG BASE;EQ 3MG BASE [AB]
  • Manufacturer: DR REDDYS LABS SA
    Approval date: June 14, 2018
    Strength(s): EQ 2MG BASE;EQ 0.5MG BASE [AB], EQ 4MG BASE;EQ 1MG BASE [AB], EQ 8MG BASE;EQ 2MG BASE [AB], EQ 12MG BASE;EQ 3MG BASE [AB]
  • Manufacturer: MYLAN TECHNOLOGIES
    Approval date: June 14, 2018
    Strength(s): EQ 8MG BASE;EQ 2MG BASE [AB], EQ 12MG BASE;EQ 3MG BASE [AB]
  • Manufacturer: MYLAN TECHNOLOGIES
    Approval date: April 17, 2020
    Strength(s): EQ 2MG BASE;EQ 0.5MG BASE [AB], EQ 4MG BASE;EQ 1MG BASE [AB]

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (buprenorphine hydrochloride; naloxone hydrochloride tablet;sublingual)

  • Manufacturer: ACTAVIS ELIZABETH
    Approval date: February 22, 2013
    Strength(s): EQ 2MG BASE;EQ 0.5MG BASE [AB], EQ 8MG BASE;EQ 2MG BASE [AB]
  • Manufacturer: AMNEAL PHARMS
    Approval date: February 22, 2013
    Strength(s): EQ 2MG BASE;EQ 0.5MG BASE [AB], EQ 8MG BASE;EQ 2MG BASE [AB]
  • Manufacturer: ETHYPHARM USA CORP
    Approval date: October 16, 2015
    Strength(s): EQ 2MG BASE;EQ 0.5MG BASE [AB], EQ 8MG BASE;EQ 2MG BASE [AB]
  • Manufacturer: HIKMA
    Approval date: June 27, 2014
    Strength(s): EQ 2MG BASE;EQ 0.5MG BASE [AB], EQ 8MG BASE;EQ 2MG BASE [AB]
  • Manufacturer: LANNETT CO INC
    Approval date: September 19, 2016
    Strength(s): EQ 2MG BASE;EQ 0.5MG BASE [AB], EQ 8MG BASE;EQ 2MG BASE [AB]
  • Manufacturer: SPECGX LLC
    Approval date: December 13, 2017
    Strength(s): EQ 2MG BASE;EQ 0.5MG BASE [AB], EQ 8MG BASE;EQ 2MG BASE [AB]
  • Manufacturer: SUN PHARM
    Approval date: August 5, 2016
    Strength(s): EQ 2MG BASE;EQ 0.5MG BASE [AB], EQ 8MG BASE;EQ 2MG BASE [AB]
  • Manufacturer: WES PHARMA INC
    Approval date: July 17, 2020
    Strength(s): EQ 2MG BASE;EQ 0.5MG BASE [AB], EQ 8MG BASE;EQ 2MG BASE [AB]

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

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.

  • Sublingual and buccal film compositions
    Patent 10,285,910
    Issued: May 14, 2019

    The present invention relates to products and methods for treatment of various symptoms in a patient, including treatment of pain suffered by a patient. The invention more particularly relates to self-supporting dosage forms which provide an active agent while providing sufficient buccal adhesion of the dosage form. Further, the present invention provides a dosage form which is useful in reducing the likelihood of diversion abuse of the active agent.

    Patent expiration dates:

    • October 11, 2022
      ✓ 
      Drug product
  • Polyethylene oxide-based films and drug delivery systems made therefrom
    Patent 8,017,150
    Issued: September 13, 2011
    Inventor(s): Yang; Robert K. & Fuisz; Richard C. & Myers; Garry L. & Fuisz; Joseph M.
    Assignee(s): MonoSol Rx, LLC

    The invention relates to the film products and methods of their preparation that demonstrate a non-self-aggregating uniform heterogeneity. Desirably, the films disintegrate in water and may be formed by a controlled drying process, or other process that maintains the required uniformity of the film. The films contain a polymer component, which includes polyethylene oxide optionally blended with hydrophilic cellulosic polymers. Desirably, the films also contain a pharmaceutical and/or cosmetic active agent with no more than a 10% variance of the active agent pharmaceutical and/or cosmetic active agent per unit area of the film.

    Patent expiration dates:

    • February 13, 2023
      ✓ 
      Drug product
  • Sublingual and buccal film compositions
    Patent 8,475,832
    Issued: July 2, 2013
    Assignee(s): RB Pharmaceuticals Limited

    The present invention relates to products and methods for treatment of narcotic dependence in a user. The invention more particularly relates to self-supporting dosage forms which provide an active agent for treating narcotic dependence while providing sufficient buccal adhesion of the dosage form.

    Patent expiration dates:

    • March 26, 2030
      ✓ 
      Patent use: THIS DRUG IS ADMINISTERED BY SUBLINGUAL ROUTE TO HUMANS FOR MAINTENANCE TREATMENT OF OPIOID DEPENDENCE
      ✓ 
      Drug product
  • Uniform films for rapid dissolve dosage form incorporating taste-masking compositions
    Patent 8,603,514
    Issued: December 10, 2013
    Assignee(s): MonoSol RX, LLC

    The present invention relates to rapid dissolve thin film drug delivery compositions for the oral administration of active components. The active components are provided as taste-masked or controlled-release coated particles uniformly distributed throughout the film composition. The compositions may be formed by wet casting methods, where the film is cast and controllably dried, or alternatively by an extrusion method.

    Patent expiration dates:

    • April 3, 2024
      ✓ 
      Patent use: TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION
      ✓ 
      Drug product
  • Sublingual and buccal film compositions
    Patent 9,687,454
    Issued: June 27, 2017
    Assignee(s): Indivior UK Limited

    The present invention relates to products and methods for treatment of narcotic dependence in a user. The invention more particularly relates to self-supporting dosage forms which provide an active agent for treating narcotic dependence while providing sufficient buccal adhesion of the dosage form.

    Patent expiration dates:

    • August 7, 2029
      ✓ 
      Patent use: TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION
      ✓ 
      Drug product
  • Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions
    Patent 9,855,221
    Issued: January 2, 2018
    Assignee(s): MonoSol Rx, LLC

    The present invention relates to water-soluble films incorporating anti-tacking agents and methods of their preparation. Anti-tacking agents may improve the flow characteristics of the compositions and thereby reduce the problem of film adhering to a user's mouth or to other units of film. In particular, the present invention relates to edible water-soluble delivery systems in the form of a film composition including a water-soluble polymer, an active component selected from cosmetic agents, pharmaceutical agents, vitamins, bioactive agents and combinations thereof and at least one anti-tacking agent.

    Patent expiration dates:

    • February 14, 2022
      ✓ 
      Drug product
  • Uniform films for rapid dissolve dosage form incorporating taste-masking compositions
    Patent 9,931,305
    Issued: April 3, 2018
    Assignee(s): MonoSol Rx, LLC

    The present invention relates to rapid dissolve thin film drug delivery compositions for the oral administration of active components. The active components are provided as taste-masked or controlled-release coated particles uniformly distributed throughout the film composition. The compositions may be formed by wet casting methods, where the film is cast and controllably dried, or alternatively by an extrusion method.

    Patent expiration dates:

    • February 14, 2022
      ✓ 
      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 (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.

Further information

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

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