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 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 20^th, 2018.

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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

Drug patent expirations by year for BRIXADI

Recent Clinical Trials for BRIXADI

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Pennsylvania	Phase 2
Columbia University Irving Medical Center	Phase 2
NYU Langone Health	Phase 2

See all BRIXADI clinical trials

Pharmacology for BRIXADI

Drug Class	Partial Opioid Agonist
Mechanism of Action	Partial Opioid Agonists

Anatomical Therapeutic Chemical (ATC) Classes for BRIXADI

N02AE	Oripavine derivatives
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

N07BC	Drugs used in opioid dependence
N07B	DRUGS USED IN ADDICTIVE DISORDERS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE

Opioid formulations
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Liquid depot formulations
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial

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Glossary

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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	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-004	May 23, 2023		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-007	May 23, 2023		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
>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

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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.

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Country	Patent Number	Title	Estimated Expiration
Austria	E501710		⤷ Try a Trial
Germany	602005008247		⤷ Try a Trial
Malaysia	189481	OPIOID FORMULATIONS	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration