Last Updated: September 24, 2026

Details for New Drug Application (NDA): 210136

✉ Email this page to a colleague

NDA 210136 describes BRIXADI, which is a drug marketed by Braeburn and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the BRIXADI profile page.

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.

Summary for 210136

Tradename:	BRIXADI
Applicant:	Braeburn
Ingredient:	buprenorphine
Patents:	8

Pharmacology for NDA: 210136

Mechanism of Action	Partial Opioid Agonists

Medical Subject Heading (MeSH) Categories for 210136

Analgesics, Opioid
Narcotic Antagonists
Narcotics

Suppliers and Packaging for NDA: 210136

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136	NDA	Braeburn Inc.	58284-208	58284-208-01	1 SYRINGE, GLASS in 1 CARTON (58284-208-01) / .16 mL in 1 SYRINGE, GLASS
BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136	NDA	Braeburn Inc.	58284-216	58284-216-01	1 SYRINGE, GLASS in 1 CARTON (58284-216-01) / .32 mL in 1 SYRINGE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS			Strength	8MG/0.16ML (50MG/ML)
Approval Date:	May 23, 2023	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	May 23, 2026
Regulatory Exclusivity Use:	NEW PRODUCT
Patent:	⤷ Start Trial	Patent Expiration:	Jul 26, 2032	Product Flag?		Substance Flag?		Delist Request?
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:	⤷ Start Trial	Patent Expiration:	Jul 26, 2032	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE

Expired US Patents for NDA 210136

Subscribe to access the full database, or Start Trial
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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

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.