BRIXADI Drug Patent Profile
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Which patents cover Brixadi, and when can generic versions of Brixadi launch?
Brixadi is a drug marketed by Braeburn and is included in one NDA. There are eight patents protecting this drug.
The generic ingredient in BRIXADI is buprenorphine. There is one drug master file entry for this compound. Ten suppliers are listed for this compound. Additional details are available on the buprenorphine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Brixadi
A generic version of BRIXADI was approved as buprenorphine by WATSON LABS TEVA on November 20th, 2018.
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Questions you can ask:
- What is the 5 year forecast for BRIXADI?
- What are the global sales for BRIXADI?
- What is Average Wholesale Price for BRIXADI?
Summary for BRIXADI
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 19 |
| Clinical Trials: | 7 |
| Patent Applications: | 1,936 |
| Drug Prices: | Drug price information for BRIXADI |
| What excipients (inactive ingredients) are in BRIXADI? | BRIXADI excipients list |
| DailyMed Link: | BRIXADI at DailyMed |
Recent Clinical Trials for BRIXADI
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Braeburn Inc | PHASE4 |
| Yale University | PHASE4 |
| Lifespan | PHASE4 |
Pharmacology for BRIXADI
| Drug Class | Partial Opioid Agonist |
| Mechanism of Action | Partial Opioid Agonists |
US Patents and Regulatory Information for BRIXADI
BRIXADI is protected by eight US patents and one FDA Regulatory Exclusivity.
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Braeburn | BRIXADI | buprenorphine | SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS | 210136-005 | May 23, 2023 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Braeburn | BRIXADI | buprenorphine | SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS | 210136-004 | May 23, 2023 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Braeburn | BRIXADI | buprenorphine | SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS | 210136-006 | May 23, 2023 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Braeburn | BRIXADI | buprenorphine | SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS | 210136-007 | May 23, 2023 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Braeburn | BRIXADI | buprenorphine | SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS | 210136-005 | May 23, 2023 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for BRIXADI
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Braeburn | BRIXADI | buprenorphine | SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS | 210136-007 | May 23, 2023 | ⤷ Start Trial | ⤷ Start Trial |
| Braeburn | BRIXADI | buprenorphine | SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS | 210136-006 | May 23, 2023 | ⤷ Start Trial | ⤷ Start Trial |
| Braeburn | BRIXADI | buprenorphine | SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS | 210136-006 | May 23, 2023 | ⤷ Start Trial | ⤷ Start Trial |
| Braeburn | BRIXADI | buprenorphine | SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS | 210136-001 | May 23, 2023 | ⤷ Start Trial | ⤷ Start Trial |
| Braeburn | BRIXADI | buprenorphine | SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS | 210136-007 | May 23, 2023 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for BRIXADI
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| L. Molteni & C. dei Fratelli Alitti Società di Esercizio S.p.A. | Sixmo | buprenorphine | EMEA/H/C/004743Sixmo is indicated for substitution treatment for opioid dependence in clinically stable adult patients who require no more than 8 mg/day of sublingual buprenorphine, within a framework of medical, social and psychological treatment. | Authorised | no | no | no | 2019-06-19 | |
| Camurus AB | Buvidal | buprenorphine | EMEA/H/C/004651Treatment of opioid dependence within a framework of medical, social and psychological treatment. Treatment is intended for use in adults and adolescents aged 16 years or over. | Authorised | no | no | no | 2018-11-20 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for BRIXADI
See the table below for patents covering BRIXADI around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Austria | E401054 | ⤷ Start Trial | |
| Austria | E462409 | ⤷ Start Trial | |
| Austria | E501710 | ⤷ Start Trial | |
| Australia | 2005249274 | ⤷ Start Trial | |
| Australia | 2005324794 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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