Orange Book product · Brand (NDA)

BRIXADI

BUPRENORPHINE

Brand (NDA)NDA 210136RX BRAEBURN

May 23, 2023

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
May 23, 2023
3 yr 1 mo ago
Exclusivity ends · NP
New product exclusivity (3 years)
May 23, 2026
27 d ago
Today
Patent 8236755 expires
Listed drug product patent expiration.
Jul 31, 2026
in 1 mo
Patent 8236292 expires
Listed drug product patent expiration.
Jan 10, 2027
in 7 mo
Patent 10912772 expires
Listed method-of-use patent (U-3617) expiration.
Jul 26, 2032
in 6 yr 2 mo
Patent 11110084 expires
Listed drug product patent expiration.
Jul 26, 2032
in 6 yr 2 mo
Patent 11135215 expires
Listed drug product patent expiration.
Jul 26, 2032
in 6 yr 2 mo
Patent 12161640 expires
Listed drug product patent expiration.
Jul 26, 2032
in 6 yr 2 mo
Patent 12318379 expires
Listed drug product patent expiration.
Jul 26, 2032
in 6 yr 2 mo
Patent 9937164 expires
Listed drug product patent expiration.
Jul 26, 2032
in 6 yr 2 mo

Active ingredient

BUPRENORPHINE

Strength

16MG/0.32ML (50MG/ML)

Dosage form

SOLUTION, EXTENDED RELEASE

Route

SUBCUTANEOUS

TE code

Not listed

Application

NDA 210136

Product number

002

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8236755	Jul 31, 2026	in 1 mo	ProductU-3620
8236292	Jan 10, 2027	in 7 mo	ProductU-3619
10912772	Jul 26, 2032	in 6 yr 2 mo	U-3617
11110084	Jul 26, 2032	in 6 yr 2 mo	ProductU-3616
11135215	Jul 26, 2032	in 6 yr 2 mo	Product
12161640	Jul 26, 2032	in 6 yr 2 mo	ProductU-4100
12318379	Jul 26, 2032	in 6 yr 2 mo	ProductU-4100
9937164	Jul 26, 2032	in 6 yr 2 mo	ProductU-3618