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Generic Zubsolv Availability

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

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

  • Manufacturer: OREXO US INC
    Approval date: July 3, 2013
    Strength(s): EQ 1.4MG BASE;EQ 0.36MG BASE, EQ 5.7MG BASE;EQ 1.4MG BASE [RLD]
  • Manufacturer: OREXO US INC
    Approval date: December 11, 2014
    Strength(s): EQ 8.6MG BASE;EQ 2.1MG BASE, EQ 11.4MG BASE;EQ 2.9MG BASE
  • Manufacturer: OREXO US INC
    Approval date: June 4, 2015
    Strength(s): EQ 2.9MG BASE;EQ 0.71MG BASE
  • Manufacturer: OREXO US INC
    Approval date: October 4, 2016
    Strength(s): EQ 0.7MG BASE;EQ 0.18MG BASE

Has a generic version of Zubsolv been approved?

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

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

  • Pharmaceutical composition for the treatment of acute disorders
    Patent 8,454,996
    Issued: June 4, 2013
    Assignee(s): Orexo AB
    A pharmaceutical composition for the treatment of acute disorders is described. The composition comprises an essentially water-free, ordered mixture of at least one pharmaceutically active agent in the form of microparticles which are adhered to the surfaces of carrier particles which are substantially larger than the particles of the active agent or agents, and are essentially water-soluble, in combination with the bioadhesion and/or mucoadhesion promoting agent. The invention also relates to a method for preparing the composition and to the use of the composition for the treatment of acute disorders.
    Patent expiration dates:
    • September 24, 2019
      ✓ 
      Patent use: SUBLINGUAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE
  • Non-abusable pharmaceutical composition comprising opioids
    Patent 8,470,361
    Issued: June 25, 2013
    Assignee(s): Orexo AB
    There is provided pharmaceutical compositions for the treatment of pain comprising a pharmacologically-effective amount of an opioid analgesic, or a pharmaceutically-acceptable salt thereof, presented in particulate form upon the surfaces of carrier particles comprising a pharmacologically-effective amount of an opioid antagonist, or a pharmaceutically-acceptable salt thereof, which carrier particles are larger in size than the particles of the opioid analgesic. The compositions are also useful in prevention of opioid abuse by addicts.
    Patent expiration dates:
    • May 22, 2030
      ✓ 
      Patent use: SUBLINGUAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE
      ✓ 
      Drug product
  • Non-abusable pharmaceutical composition comprising opioids
    Patent 8,658,198
    Issued: February 25, 2014
    Assignee(s): Orexo AB
    There is provided pharmaceutical compositions for the treatment of pain comprising a pharmacologically-effective amount of an opioid analgesic, or a pharmaceutically-acceptable salt thereof, presented in particulate form upon the surfaces of carrier particles comprising a pharmacologically-effective amount of an opioid antagonist, or a pharmaceutically-acceptable salt thereof, which carrier particles are larger in size than the particles of the opioid analgesic. The compositions are also useful in prevention of opioid abuse by addicts.
    Patent expiration dates:
    • December 3, 2027
      ✓ 
      Patent use: SUBLINGUAL OR BUCCAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE
      ✓ 
      Drug product
  • Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
    Patent 8,940,330
    Issued: January 27, 2015
    Assignee(s): Orexo AB
    There is provided pharmaceutical compositions for the treatment of e.g. opioid dependency comprising microparticles of a pharmacologically-effective amount of buprenorphine, or a pharmaceutically-acceptable salt thereof, in associative admixture with particles comprising a weak acid, or particles comprising weakly-acidic buffer forming materials. The composition may further comprise a disintegrant and/or particles of a pharmacologically-effective amount of naloxone, or a pharmaceutically-acceptable salt thereof. The compositions are useful in the treatment of opioid dependency/addiction and/or pain.
    Patent expiration dates:
    • September 18, 2032
      ✓ 
      Drug product
  • Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
    Patent 9,259,421
    Issued: February 16, 2016
    Assignee(s): Orexo AB
    There is provided pharmaceutical compositions for the treatment of e.g. opioid dependency comprising microparticles of a pharmacologically-effective amount of buprenorphine, or a pharmaceutically-acceptable salt thereof, in associative admixture with particles comprising a weak acid, or particles comprising weakly-acidic buffer forming materials. The composition may further comprise a disintegrant and/or particles of a pharmacologically-effective amount of naloxone, or a pharmaceutically-acceptable salt thereof. The compositions are useful in the treatment of opioid dependency/addiction and/or pain.
    Patent expiration dates:
    • September 18, 2032
      ✓ 
      Drug product
  • Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
    Patent 9,439,900
    Issued: September 13, 2016
    Assignee(s): Orexo AB
    There is provided pharmaceutical compositions for the treatment of e.g. opioid dependency comprising microparticles of a pharmacologically-effective amount of buprenorphine, or a pharmaceutically-acceptable salt thereof, in associative admixture with particles comprising a weak acid, or particles comprising weakly-acidic buffer forming materials. The composition may further comprise a disintegrant and/or particles of a pharmacologically-effective amount of naloxone, or a pharmaceutically-acceptable salt thereof. The compositions are useful in the treatment of opioid dependency/addiction and/or pain.
    Patent expiration dates:
    • September 18, 2032
      ✓ 
      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 10, 2018 - REVISIONS TO THE LABELING TO PERMIT THE USE OF ZUBSOLV AS INITIAL ('INDUCTION') TREATMENT OF OPIOID DEPENDENCE

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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