Generic Zubsolv Availability
Last updated on Nov 6, 2024.
Zubsolv is a brand name of buprenorphine/naloxone, approved by the FDA in the following formulation(s):
ZUBSOLV (buprenorphine hydrochloride; naloxone hydrochloride - tablet;sublingual)
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Manufacturer: OREXO US INC
Approval date: July 3, 2013
Strength(s): EQ 1.4MG BASE;EQ 0.36MG BASE [RLD], 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 [RLD], EQ 11.4MG BASE;EQ 2.9MG BASE [RLD] -
Manufacturer: OREXO US INC
Approval date: June 4, 2015
Strength(s): EQ 2.9MG BASE;EQ 0.71MG BASE [RLD] -
Manufacturer: OREXO US INC
Approval date: October 4, 2016
Strength(s): EQ 0.7MG BASE;EQ 0.18MG BASE [RLD]
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: 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.
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Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Patent 10,874,661
Issued: December 29, 2020
Inventor(s): Fischer Andreas
Assignee(s): OREXO ABThere 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✓
- September 18, 2032
-
Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Patent 10,946,010
Issued: March 16, 2021
Inventor(s): Fischer Andreas
Assignee(s): OREXO ABThere 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✓
- September 18, 2032
-
Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Patent 11,020,387
Issued: June 1, 2021
Inventor(s): Fischer Andreas
Assignee(s): OREXO ABThere 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✓✓
- September 18, 2032
-
Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Patent 11,020,388
Issued: June 1, 2021
Inventor(s): Fischer Andreas
Assignee(s): OREXO ABThere 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 to useful in the treatment of opioid dependency/addiction and/or pain.
Patent expiration dates:
- September 18, 2032✓✓
- September 18, 2032
-
Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Patent 11,433,066
Issued: September 6, 2022
Inventor(s): Fischer Andreas
Assignee(s): OREXO ABThere 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✓
- September 18, 2032
-
Non-abusable pharmaceutical composition comprising opioids
Patent 8,470,361
Issued: June 25, 2013
Inventor(s): Pettersson Anders
Assignee(s): Orexo ABThere 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✓✓
- May 22, 2030
-
Non-abusable pharmaceutical composition comprising opioids
Patent 8,658,198
Issued: February 25, 2014
Inventor(s): Pettersson Anders
Assignee(s): Orexo ABThere 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✓✓
- December 3, 2027
-
Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Patent 8,940,330
Issued: January 27, 2015
Inventor(s): Fischer Andreas
Assignee(s): Orexo ABThere 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✓
- September 18, 2032
-
Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Patent 9,259,421
Issued: February 16, 2016
Inventor(s): Fischer Andreas
Assignee(s): Orexo ABThere 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✓
- September 18, 2032
-
Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Patent 9,439,900
Issued: September 13, 2016
Inventor(s): Fischer Andreas
Assignee(s): Orexo ABThere 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✓✓
- September 18, 2032✓
- September 18, 2032
More about Zubsolv (buprenorphine / naloxone)
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- Drug class: narcotic analgesic combinations
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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. |
Further information
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