BRIXADI Drug Patent Profile
✉ Email this page to a colleague
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 seven patents protecting this drug.
This drug has one hundred and fifteen patent family members in thirty-three countries.
The generic ingredient in BRIXADI is buprenorphine. There are twenty-nine drug master file entries for this compound. Nine 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.
AI Research Assistant
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
International Patents: | 115 |
US Patents: | 7 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 19 |
Clinical Trials: | 3 |
Patent Applications: | 3,976 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for BRIXADI |
What excipients (inactive ingredients) are in BRIXADI? | BRIXADI excipients list |
DailyMed Link: | BRIXADI at DailyMed |
![BRIXADI drug patent expirations Drug patent expirations by year for BRIXADI](/p/graph/s/t/BRIXADI-patent-expirations.png)
![Drug Prices for BRIXADI](/p/graph/drug-price/BRIXADI.png)
Recent Clinical Trials for BRIXADI
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Pennsylvania | Phase 2 |
Mclean Hospital | Phase 2 |
Columbia University Irving Medical Center | Phase 2 |
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 seven US patents and one FDA Regulatory Exclusivity.
Patents protecting BRIXADI
Opioid formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE. A METHOD OF TREATING OPIOID WITHDRAWAL USING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE
Opioid formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Liquid depot formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD OF DELIVERY OF A BIOACTIVE AGENT BY SUBCUTANEOUS INJECTION. A METHOD OF TREATMENT OF A HUMAN FOR ADDICTION
Opioid depot formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD OF DELIVERY OF AN OPIOID BIOACTIVE AGENT. A METHOD OF TREATMENT OR PROPHYLAXIS OF A HUMAN OR NON-HUMAN ANIMAL FOR THE TREATMENT OF OPIOID ADDICTION AND/OR THE SYMPTOMS OF OPIOID WITHDRAWAL
Lipid depot formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD OF DELIVERY OF A BIOACTIVE AGENT BY SUBCUTANEOUS INJECTION. A METHOD OF TREATMENT OF A HUMAN FOR ADDICTION
Opioid formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD OF SUSTAINED DELIVERY OF BUPRENORPHINE TO A HUMAN OR NON-HUMAN ANIMAL BODY. A METHOD FOR TREATMENT FOR OPIOID MAINTENANCE THERAPY
FDA Regulatory Exclusivity protecting BRIXADI
NEW PRODUCT
Exclusivity Expiration: ⤷ Sign Up
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 | 210136-006 | May 23, 2023 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Braeburn | BRIXADI | buprenorphine | SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS | 210136-004 | May 23, 2023 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Braeburn | BRIXADI | buprenorphine | SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS | 210136-007 | May 23, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity 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/004743 Sixmo 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/004651 Treatment 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 |
---|---|---|---|
European Patent Office | 1848403 | FORMULATIONS BIOADHESIVES TOPIQUES (TOPICAL BIOADHESIVE FORMULATIONS) | ⤷ Sign Up |
European Patent Office | 1845942 | FORMULATIONS D'ANALOGUES DE GNRH (GNRH ANALOGUE FORMULATIONS) | ⤷ Sign Up |
China | 101014319 | Liquid depot formulation | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |