Is there a generic for Buprenorphine?

Yes. The FDA Orange Book lists 5 approved generic (ANDA) applications for Buprenorphine, referencing the brand BRIXADI. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Buprenorphine?

BRIXADI (NDA 210136, BRAEBURN) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Buprenorphine?

The Orange Book lists 21 patents against Buprenorphine products, with the earliest listed expiry in 2026. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Does Buprenorphine have FDA marketing exclusivity?

Yes. The Orange Book records 9 marketing-exclusivity periods for Buprenorphine. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

What dosage forms of Buprenorphine are approved?

Buprenorphine is approved in the following dosage forms: film, extended release, solution, extended release.

FDA Orange Book · active-ingredient family

Buprenorphine

Buprenorphine: 3 brands, 5 generics; first approved Jun 30, 2010; generic available.

Generic available9 exclusivity periodsHas discontinued products

Generic status & protection

Generic available — 5 ANDA applications approved.

Earliest patent expiry Jul 31, 2026Latest exclusivity ends Feb 21, 2028

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Jul 31, 2026

in 20 d

Originator applications

Brand (NDA) products

BRIXADIRLDRS

BRAEBURNNDA 21013620237 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
8MG/0.16ML (50MG/ML)	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	Rx	—
16MG/0.32ML (50MG/ML)	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	Rx	—
24MG/0.48ML (50MG/ML)	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	Rx	—
32MG/0.64ML (50MG/ML)	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	Rx	—
64MG/0.18ML (356MG/ML)	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	Rx	—
96MG/0.27ML (356MG/ML)	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	Rx	—
128MG/0.36ML (356MG/ML)	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	Rx	—

SUBLOCADERLD

INDIVIORNDA 20981920172 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG/0.5ML (100MG/0.5ML)	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	Rx	—
300MG/1.5ML (200MG/ML)	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	Rx	—

BUTRANSRLD

KNOA PHARMANDA 02130620105 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MCG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB
10MCG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB
20MCG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB
15MCG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB
7.5MCG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB

Abbreviated applications

Generic (ANDA) products (5)

BUPRENORPHINE

STRIDES PHARMA INTLANDA 20749020225 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MCG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB
10MCG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB
15MCG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB
20MCG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB
7.5MCG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Discontinued	—

BUPRENORPHINE

DIFGEN PHARMSANDA 21027220215 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MCG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB
7.5MCG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB
10MCG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB
15MCG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB
20MCG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB

BUPRENORPHINE

MYLAN TECH VIATRISANDA 21016220215 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MCG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Discontinued	—
7.5MCG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Discontinued	—
10MCG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Discontinued	—
15MCG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Discontinued	—
20MCG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Discontinued	—

BUPRENORPHINE

AMNEALANDA 21158620205 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MCG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB
7.5MCG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB
10MCG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB
15MCG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB
20MCG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB

BUPRENORPHINE

WATSON LABS TEVAANDA 20493720185 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MCG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB
10MCG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB
15MCG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB
20MCG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB
7.5MCG/HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Hatch-Waxman

Marketing exclusivity

Marketing exclusivity (9)

NPNew product exclusivity (3 years)
May 23, 2026
2 mo ago
NPNew product exclusivity (3 years)
May 23, 2026
2 mo ago
NPNew product exclusivity (3 years)
May 23, 2026
2 mo ago
NPNew product exclusivity (3 years)
May 23, 2026
2 mo ago
NPNew product exclusivity (3 years)
May 23, 2026
2 mo ago
NPNew product exclusivity (3 years)
May 23, 2026
2 mo ago
NPNew product exclusivity (3 years)
May 23, 2026
2 mo ago
M-314New use / labeling-change exclusivity (3 years)
Feb 21, 2028
in 1 yr 8 mo
M-314New use / labeling-change exclusivity (3 years)
Feb 21, 2028
in 1 yr 8 mo

Orange Book patent file

Listed patents

Listed patents (21)

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 20 d	ProductU-3620
8236292	Jan 10, 2027	in 6 mo	ProductU-3619
9827241	Jun 06, 2031	in 5 yr	ProductU-2206
9782402	Jun 06, 2031	in 5 yr	ProductU-2180
9272044	Jun 06, 2031	in 5 yr	U-2176
10198218	Jun 06, 2031	in 5 yr	U-2489
9498432	Jun 06, 2031	in 5 yr	ProductU-2179
10592168	Jun 06, 2031	in 5 yr	U-2489
10558394	Jun 25, 2031	in 5 yr	Product
8975270	Sep 05, 2031	in 5 yr 3 mo	ProductU-2206
8921387	Jan 06, 2032	in 5 yr 7 mo	ProductU-2174
12318379	Jul 26, 2032	in 6 yr 2 mo	ProductU-4100
12161640	Jul 26, 2032	in 6 yr 2 mo	ProductU-4100
11110084	Jul 26, 2032	in 6 yr 2 mo	ProductU-3616
10912772	Jul 26, 2032	in 6 yr 2 mo	U-3617
9937164	Jul 26, 2032	in 6 yr 2 mo	ProductU-3618
11135215	Jul 26, 2032	in 6 yr 2 mo	Product
11000520	Nov 06, 2035	in 9 yr 6 mo	U-3111
11839611	Nov 06, 2035	in 9 yr 6 mo	U-3111
12622904	Nov 06, 2035	in 9 yr 6 mo	U-4528
10646484	Jun 22, 2038	in 12 yr 1 mo	U-2489

FDA approval span

Approval history

First approval

Jun 30, 2010

16 yr 3 mo ago

Most recent approval

May 23, 2023

3 yr 2 mo ago

Approvals span 2010–2023 across 8 FDA applications.

Brand (NDA) 338%

Generic (ANDA) 563%

Buprenorphine — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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