Generic Belbuca Availability
Last updated on Apr 10, 2025.
Belbuca is a brand name of buprenorphine, approved by the FDA in the following formulation(s):
BELBUCA (buprenorphine hydrochloride - film;buccal)
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Manufacturer: BDSI
Approval date: October 23, 2015
Strength(s): EQ 0.075MG BASE [RLD], EQ 0.15MG BASE [RLD], EQ 0.3MG BASE [RLD], EQ 0.45MG BASE [RLD], EQ 0.6MG BASE [RLD], EQ 0.75MG BASE [RLD], EQ 0.9MG BASE [RLD]
Is there a generic version of Belbuca available?
No. There is currently no therapeutically equivalent version of Belbuca available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Belbuca. 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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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
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Transmucosal drug delivery devices for use in chronic pain relief
Patent 9,901,539
Issued: February 27, 2018
Inventor(s): Finn Andrew & Vasisht Niraj
Assignee(s): BioDelivery Sciences International, Inc.Provided herein are methods for treating chronic pain by administering low doses of buprenorphine twice daily (or once daily) via a transmucosal drug delivery device. The methods and devices efficiently treat chronic pain without significant side effects.
Patent expiration dates:
- December 21, 2032✓
- December 21, 2032
More about Belbuca (buprenorphine)
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- Drug class: Opioids (narcotic analgesics)
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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.
