Generic Bunavail Availability
Last updated on Apr 10, 2025.
Bunavail is a brand name of buprenorphine/naloxone, approved by the FDA in the following formulation(s):
BUNAVAIL (buprenorphine hydrochloride; naloxone hydrochloride - film;buccal)
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Manufacturer: BDSI
Approval date: June 6, 2014
Strength(s): EQ 2.1MG BASE;EQ 0.3MG BASE (discontinued) [RLD], EQ 4.2MG BASE;EQ 0.7MG BASE (discontinued) [RLD], EQ 6.3MG BASE;EQ 1MG BASE (discontinued) [RLD]
All of the above formulations have been discontinued.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Bunavail. 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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Transmucosal delivery devices with enhanced uptake
Patent 8,147,866
Issued: April 3, 2012
Inventor(s): Finn Andrew & Vasisht Niraj
Assignee(s): BioDelivery Sciences International, Inc.The present invention provides methods for enhancing transmucosal uptake of a medicament, e.g., fentanyl or buprenorphine, to a subject and related devices. The method includes administering to a subject a transmucosal drug delivery device comprising the medicament. Also provided are devices suitable for transmucosal administration of a medicament to a subject and methods of their administration and use. The devices include a medicament disposed in a mucoadhesive polymeric diffusion environment and a barrier environment.
Patent expiration dates:
- July 23, 2027✓✓
- July 23, 2027
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Abuse-resistant mucoadhesive devices for delivery of buprenorphine
Patent 8,703,177
Issued: April 22, 2014
Inventor(s): Finn Andrew & Vasisht Niraj
Assignee(s): BioDelivery Sciences International, Inc.The present invention provides abuse deterrent mucoadhesive devices for delivery of buprenorphine. Each device comprises a mucoadhesive layer and a backing layer, and the pH in each layer is selected, such that absorption of buprenorphine is maximized.
Patent expiration dates:
- August 20, 2032✓
- August 20, 2032
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Abuse resistant transmucosal drug delivery device
Patent 9,522,188
Issued: December 20, 2016
Inventor(s): Finn Andrew & Vasisht Niraj
Assignee(s): BioDelivery Sciences International, Inc.The present invention relates to a solid pharmaceutical dosage form for abusable drug delivery with reduced illicit abuse potential. The dosage form is presented as a bioerodable transmucosal delivery device that includes an abusable drug and an antagonist to the abusable drug associated with an abuse-resistant matrix. The devices of the invention may be in the form of a layered film or a tablet. Upon application in a non-abusive manner, the device adheres to the mucosal surface, providing transmucosal drug delivery of the drug with minimal absorption of the antagonist into systemic circulation.
Patent expiration dates:
- April 24, 2035✓
- April 24, 2035
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Transmucosal delivery devices with enhanced uptake
Patent 9,655,843
Issued: May 23, 2017
Inventor(s): Finn Andrew & Vasisht Niraj
Assignee(s): BioDelivery Sciences International, Inc.The present invention provides methods for enhancing transmucosal uptake of a medicament, e.g., fentanyl or buprenorphine, to a subject and related devices. The method includes administering to a subject a transmucosal drug delivery device comprising the medicament. Also provided are devices suitable for transmucosal administration of a medicament to a subject and methods of their administration and use. The devices include a medicament disposed in a mucoadhesive polymeric diffusion environment and a barrier environment.
Patent expiration dates:
- July 23, 2027✓✓
- July 23, 2027
More about Bunavail (buprenorphine / naloxone)
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- FDA approval history
- 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
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
