Skip to main content

Generic Belbuca Availability

Last updated on Oct 6, 2021.

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

BELBUCA (buprenorphine hydrochloride - film;buccal)

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

Has a generic version of Belbuca been approved?

A generic version of Belbuca has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Belbuca and have been approved by the FDA:

buprenorphine hydrochloride film;buccal

  • Manufacturer: ALVOGEN
    Approval date: August 3, 2021
    Strength(s): EQ 0.075MG BASE [AB], EQ 0.15MG BASE [AB], EQ 0.3MG BASE [AB], EQ 0.45MG BASE [AB], EQ 0.6MG BASE [AB], EQ 0.75MG BASE [AB], EQ 0.9MG BASE [AB]

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.

  • 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
  • Transmucosal delivery devices with enhanced uptake
    Patent 9,655,843
    Issued: May 23, 2017
    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: MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
      ✓ 
      Drug product
  • Transmucosal drug delivery devices for use in chronic pain relief
    Patent 9,901,539
    Issued: February 27, 2018
    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
      ✓ 
      Patent use: MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE

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.
AB Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (e.g. AB1, AB2, AB7). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.