Orange Book product · Brand (NDA)

BELBUCA

BUPRENORPHINE HYDROCHLORIDE

Brand (NDA)NDA 207932RX BDSI

Oct 23, 2015

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Oct 23, 2015
10 yr 10 mo ago
Today
Patent 8147866 expires
Listed drug product patent expiration.
Jul 23, 2027
in 1 yr 1 mo
Patent 9655843 expires
Listed drug product patent expiration.
Jul 23, 2027
in 1 yr 1 mo
Patent 9901539 expires
Listed method-of-use patent (U-1556) expiration.
Dec 21, 2032
in 6 yr 7 mo

Active ingredient

BUPRENORPHINE HYDROCHLORIDE

Strength

EQ 0.75MG BASE

Dosage form

FILM

Route

BUCCAL

TE code

Not listed

Application

NDA 207932

Product number

006

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

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
8147866	Jul 23, 2027	in 1 yr 1 mo	ProductU-1769
9655843	Jul 23, 2027	in 1 yr 1 mo	ProductU-1556
9901539	Dec 21, 2032	in 6 yr 7 mo	U-1556