Brixadi is a drug owned by Braeburn Inc. It is protected by 9 US drug patents filed from 2023 to 2025. Out of these, 7 drug patents are active and 2 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 26, 2032. Details of Brixadi's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US12318379 | Opioid Formulations |
Jul, 2032
(5 years from now) | Active |
| US11110084 | Opioid formulations |
Jul, 2032
(5 years from now) | Active |
| US10912772 | Opioid formulations |
Jul, 2032
(5 years from now) | Active |
| US9937164 | Opioid formulations |
Jul, 2032
(5 years from now) | Active |
| US11135215 | Opioid formulations |
Jul, 2032
(5 years from now) | Active |
| US12161640 | Opioid formulations |
Jul, 2032
(5 years from now) | Active |
| US8236292 | Liquid depot formulations |
Jan, 2027
(3 months from now) | Active |
| US8236755 | Opioid depot formulations |
Jul, 2026
(2 months ago) |
Expired
|
| US8545832 | Lipid depot formulations |
Jun, 2025
(1 year, 4 months ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical
activities like
abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease
the life of a
patent hence affecting its expiry date and in turn affecting the generic launch date of that drug.
Tracking these
ongoing activities on a patent application helps to keep an eye on the latest developments in the
patent process of
the drug which can give an idea of how early a drug's generic could be available. The next section
provides a list of
recent legal activities on Brixadi's patents.
Latest Legal Activities on Brixadi's Patents
Given below is the list of recent legal activities going on the following patents of Brixadi.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 10 Oct, 2025 | US9937164 |
| Recordation of Patent Grant Mailed | 10 Jun, 2025 | US12318379 |
| Email Notification | 03 Jun, 2025 | US12318379 |
| Patent Issue Date Used in PTA Calculation | 03 Jun, 2025 | US12318379 |
| Mail Patent eGrant Notification | 03 Jun, 2025 | US12318379 |
| Recordation of Patent eGrant | 03 Jun, 2025 | US12318379 |
| Patent eGrant Notification | 03 Jun, 2025 | US12318379 |
| Email Notification | 22 May, 2025 | US12318379 |
| Issue Notification Mailed | 21 May, 2025 | US12318379 |
| Dispatch to FDC | 13 May, 2025 | US12318379 |
FDA has granted several exclusivities to Brixadi. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Brixadi, regardless of the status of it's patents. These exclusivities hence play a crucial role in
delaying the generic
launch. Given below are details of the exclusivities granted to
Brixadi.
Exclusivity Information
Brixadi holds 1 exclusivities. All of its exclusivities have expired in 2026. Details of Brixadi's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | May 23, 2026 |
US patents provide insights into the exclusivity only within the United States, but
Brixadi is protected by patents in multiple countries.
Understanding
the full scope
of patent protection is crucial in strategizing market entry. By looking at the broader patent
landscape, you can
identify markets with weaker patent protection which could be ideal generic entry points. The
following section offers
details on Brixadi's family patents as well as insights into
ongoing legal events
on those patents.
Brixadi's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Brixadi:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
Generic Launch
Generic Release Date:
Brixadi's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 26, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Brixadi Generic API suppliers:
Buprenorphine is the generic name for the brand Brixadi. 5 different companies have already filed for the generic of Brixadi, with Amneal having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Brixadi's generic
Alternative Brands for Brixadi
Brixadi which is used for managing opioid addiction and withdrawal symptoms through buprenorphine maintenance therapy., has several other brand drugs using the same active ingredient (Buprenorphine). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | ||
|---|---|---|---|
| Bdsi |
| ||
| Edenbridge Pharms |
| ||
| Indivior |
| ||
| Knoa Pharma |
| ||
| Reacx Pharms |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Buprenorphine, Brixadi's active ingredient. Check the complete list of approved generic manufacturers for Brixadi
About Brixadi
Brixadi is a drug owned by Braeburn Inc. It is used for managing opioid addiction and withdrawal symptoms through buprenorphine maintenance therapy. Brixadi uses Buprenorphine as an active ingredient. Brixadi was launched by Braeburn in 2023.
Approval Date:
Brixadi was approved by FDA for market use on 23 May, 2023.
Active Ingredient:
Brixadi uses Buprenorphine as the active ingredient. Check out other Drugs and Companies using Buprenorphine ingredient
Treatment:
Brixadi is used for managing opioid addiction and withdrawal symptoms through buprenorphine maintenance therapy.
Dosage:
Brixadi is available in solution, extended release form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 16MG/0.32ML (50MG/ML) | SOLUTION, EXTENDED RELEASE | Prescription | SUBCUTANEOUS |
| 24MG/0.48ML (50MG/ML) | SOLUTION, EXTENDED RELEASE | Prescription | SUBCUTANEOUS |
| 128MG/0.36ML (356MG/ML) | SOLUTION, EXTENDED RELEASE | Prescription | SUBCUTANEOUS |
| 8MG/0.16ML (50MG/ML) | SOLUTION, EXTENDED RELEASE | Prescription | SUBCUTANEOUS |
| 96MG/0.27ML (356MG/ML) | SOLUTION, EXTENDED RELEASE | Prescription | SUBCUTANEOUS |
| 32MG/0.64ML (50MG/ML) | SOLUTION, EXTENDED RELEASE | Prescription | SUBCUTANEOUS |
| 64MG/0.18ML (356MG/ML) | SOLUTION, EXTENDED RELEASE | Prescription | SUBCUTANEOUS |