Generic Brixadi Availability
Last updated on Jan 8, 2025.
Brixadi is a brand name of buprenorphine, approved by the FDA in the following formulation(s):
BRIXADI (buprenorphine - solution, extended release;subcutaneous)
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Manufacturer: BRAEBURN
Approval date: May 23, 2023
Strength(s): 8MG/0.16ML (50MG/ML) [RLD], 16MG/0.32ML (50MG/ML) [RLD], 24MG/0.48ML (50MG/ML) [RLD], 32MG/0.64ML (50MG/ML) [RLD], 64MG/0.18ML (356MG/ML) [RLD], 96MG/0.27ML (356MG/ML) [RLD], 128MG/0.36ML (356MG/ML) [RLD]
Has a generic version of Brixadi been approved?
No. There is currently no therapeutically equivalent version of Brixadi available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Brixadi. 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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Opioid formulations
Patent 10,912,772
Issued: February 9, 2021
Inventor(s): Tiberg Fredrik & Harwigsson Ian & Johnsson Markus
Assignee(s): Camurus ABA depot precursor formulation comprising:
Patent expiration dates:
- July 26, 2032✓
- July 26, 2032
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Patent 11,110,084
Patent expiration dates:
- July 26, 2032✓✓
- July 26, 2032
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Opioid formulations
Patent 11,135,215
Issued: October 5, 2021
Inventor(s): Tiberg Fredrik & Harwigsson Ian & Johnsson Markus
Assignee(s): Camurus ABA depot precursor formulation comprising:
Patent expiration dates:
- July 26, 2032✓
- July 26, 2032
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Liquid depot formulations
Patent 8,236,292
Issued: August 7, 2012
Inventor(s): Thuresson Krister & Tiberg Fredrik & Johansson Markus & Harwigsson Ian & Joabsson Fredrik & Johnsson Markus
Assignee(s): Camurus ABThe present invention relates to pre-formulations comprising low viscosity, non-liquid crystalline, mixtures of: a) at least one neutral diacyl lipid and/or at least one tocopherol; b) at least one phospholipid; c) at least one biocompatible, oxygen containing, low viscosity organic solvent; wherein at least one bioactive agent is dissolved or dispersed in the low viscosity mixture and wherein the pre-formulation forms, or is capable of forming, at least one liquid crystalline phase structure upon contact with an aqueous fluid. The preformulations are suitable for generating parenteral, non-parenteral and topical depot compositions for sustained release of active agents. The invention additionally relates to a method of delivery of an active agent comprising administration of a preformulation of the invention, a method of treatment comprising administration of a preformulation of the invention and the use of a preformulation of the invention in a method for the manufacture of a medicament.
Patent expiration dates:
- January 10, 2027✓✓
- January 10, 2027
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Opioid depot formulations
Patent 8,236,755
Issued: August 7, 2012
Inventor(s): Thuresson Krister & Tiberg Fredrik & Johansson Markus & Harwigsson Ian & Joabsson Fredrik & Johnsson Markus
Assignee(s): Camurus ABThe present invention relates to pre-formulations comprising low viscosity, non-liquid crystalline, mixtures of:
Patent expiration dates:
- July 31, 2026✓✓
- July 31, 2026
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Lipid depot formulations
Patent 8,545,832
Issued: October 1, 2013
Inventor(s): Thuresson Krister & Tiberg Fredrik & Johansson Markus & Harwigsson Ian & Joabsson Fredrik & Johnsson Markus
Assignee(s): Camarus ABThe present invention relates to pre-formulations comprising low viscosity, non-liquid crystalline, mixtures of: a) at least one neutral diacyl lipid and/or at least one tocopherol; b) at least one phospholipid; c) at least one biocompatible, oxygen containing, low viscosity organic solvent; wherein at least one bioactive agent is dissolved or dispersed in the low viscosity mixture and wherein the pre-formulation forms, or is capable of forming, at least one liquid crystalline phase structure upon contact with an aqueous fluid. The preformulations are suitable for generating parenteral, non-parenteral and topical depot compositions for sustained release of active agents. The invention additionally relates to a method of delivery of an active agent comprising administration of a preformulation of the invention, a method of treatment comprising administration of a preformulation of the invention and the use of a preformulation of the invention in a method for the manufacture of a medicament.
Patent expiration dates:
- June 6, 2025✓✓
- June 6, 2025
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Opioid formulations
Patent 9,937,164
Issued: April 10, 2018
Inventor(s): Tiberg Fredrik & Harwigsson Ian & Johnsson Markus
Assignee(s): Camurus ABA depot precursor formulation comprising: a) a controlled-release matrix; b) at least oxygen containing organic solvent; c) at least 12% by weigh of at least one active agent selected from buprenorphine and salts thereof, calculated as buprenorphine free base. Corresponding depot compositions and methods of treatment in pain management, by opioid maintenance and related methods are provided.
Patent expiration dates:
- July 26, 2032✓✓
- July 26, 2032
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:
- May 23, 2026 - NEW PRODUCT
More about Brixadi (buprenorphine)
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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.