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;sublingual)

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

Has a generic version of Suboxone been approved?

No. There is currently no therapeutically equivalent version of Suboxone available in the United States.

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: 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.

  • 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
      ✓ 
      Drug product
    • April 3, 2024
      ✓ 
      Patent use: TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION
      ✓ 
      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:
    • August 30, 2013 -

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.
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