Is Belbuca still available?

Yes. Belbuca (NDA 207932) is listed with marketing status Prescription in the FDA Orange Book.

Does Belbuca have a generic?

Yes. The Orange Book lists 15 approved generic (ANDA) applications sharing Belbuca's active ingredient (Buprenorphine Hydrochloride). A generic with an "A"-rated therapeutic-equivalence code is considered substitutable for the brand.

When do Belbuca's patents expire?

The FDA Orange Book lists 3 patents against Belbuca, with the last listed patent expiring Dec 21, 2032. A generic launching before a listed patent expires generally must file a Paragraph IV certification.

What is Belbuca's FDA application number?

Belbuca is approved under NDA 207932, held by Bdsi.

Orange Book product · Brand (NDA)

Belbuca

Buprenorphine Hydrochloride

Brand (NDA)NDA 207932RLD Bdsi

Approved

Oct 23, 2015

Application

Brand (NDA)

TE code

Not listed

Listed patents

Belbuca (Buprenorphine Hydrochloride) is Bdsi's brand-name drug, approved by the FDA under NDA 207932 in 2015. It is a reference-listed drug (RLD) — the approved product that generic ANDA applicants must show their version is equivalent to. 15 approved generics share this drug's active ingredient. The FDA Orange Book lists 3 patents against it, the last expiring 2032.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Approval
FDA approval date of this drug product.
Oct 23, 2015
10 yr 11 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 6 mo

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

FDA product record

Pharmaceutical detail

Active ingredient

BUPRENORPHINE HYDROCHLORIDE

Strength

EQ 0.45MG BASE

Dosage form

FILM

Route

BUCCAL

TE code

Not listed

Application

NDA 207932

Product number

004

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Same application

Other strengths in NDA 207932

Brand + generics

Active-ingredient family

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

View full Buprenorphine Hydrochloride family

Orange Book patent file

Listed patents

Listed patents (3)

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 6 mo	U-1556

Belbuca — frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this product, from the FDA Orange Book.

Built directly from the FDA Orange Book data file. This product page links back to the Buprenorphine Hydrochloride active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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