Suboxone

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

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

• 
  Manufacturer: RECKITT BENCKISER
  
  Approval date: October 8, 2002
  
  Strength(s): 2MG;0.5MG, 8MG;2MG ^[RLD]

SUBOXONE (buprenorphine; naloxone - film; sublingual)

• 
  Manufacturer: RECKITT BENCKISER
  
  Approval date: August 30, 2010
  
  Strength(s): 2MG;0.5MG, 8MG;2MG ^[RLD]

Has a generic version of Suboxone been approved?

No. There is currently no therapeutically equivalent version of Suboxone available.

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:
  
  
  • September 10, 2023
    
    ✓ 
    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 - NEW DOSAGE FORM
  
  

See also...

• Suboxone Consumer Information (Drugs.com)
• Suboxone Consumer Information (Wolters Kluwer)
• Suboxone Film Consumer Information (Wolters Kluwer)
• Suboxone Consumer Information (Cerner Multum)
• Suboxone Advanced Consumer Information (Micromedex)
• Buprenorphine/Naloxone Consumer Information (Wolters Kluwer)
• Buprenorphine/Naloxone Film Consumer Information (Wolters Kluwer)
• Buprenorphine and naloxone Consumer Information (Cerner Multum)
• Buprenorphine and naloxone Sublingual Advanced Consumer Information (Micromedex)