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Generic Belbuca Availability

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

BELBUCA (buprenorphine hydrochloride - film;buccal)

  • Manufacturer: ENDO PHARMS INC
    Approval date: October 23, 2015
    Strength(s): EQ 0.075MG BASE, EQ 0.15MG BASE, EQ 0.3MG BASE, EQ 0.45MG BASE, EQ 0.6MG BASE, EQ 0.75MG BASE, EQ 0.9MG BASE [RLD]

Has a generic version of Belbuca been approved?

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: 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.

  • Bioerodable film for delivery of pharmaceutical compounds of mucosal surfaces
    Patent 6,159,498
    Issued: December 12, 2000
    Inventor(s): Tapolsky; Gilles H. & Osborne; David W.
    Assignee(s): Virotex Corporation
    The present invention relates to water-soluble, bioerodable pharmaceutical delivery device for application to mucosal surfaces. The device comprises an adhesive layer and a non-adhesive backing layer, and the pharmaceutical may be provided in either or both layers. Upon application, the device adheres to the mucosal surface, providing drug delivery and protection to the treatment site.
    Patent expiration dates:
    • October 18, 2016
      ✓ 
      Drug product
  • Pharmaceutical carrier device suitable for delivery of pharmaceutical compounds to mucosal surfaces
    Patent 7,579,019
    Issued: August 25, 2009
    Inventor(s): Tapolsky; Gilles H. & Osborne; David W.
    Assignee(s): Arius Two, Inc.
    The present invention relates to a pharmaceutical delivery device for application of a pharmaceutical to mucosal surfaces. The device comprises an adhesive layer and a non-adhesive backing layer, and the pharmaceutical may be provided in either or both layers. Upon application, the device adheres to the mucosal surface, providing localized drug delivery and protection to the treatment site. The kinetics of erodability are easily adjusted by varying the number of layers and/or the components.
    Patent expiration dates:
    • January 22, 2020
      ✓ 
      Patent use: TREATEMENT OF PAIN BY TRANSMUCOSAL DELIVERY OF BUPRENORPHINE
  • 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
      ✓ 
      Patent use: TREATEMENT OF PAIN BY TRANSMUCOSAL DELIVERY OF BUPRENORPHINE
      ✓ 
      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:
    • October 23, 2018 - NEW PRODUCT

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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