Is Buprenorphine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 10 valid registrations of Buprenorphine, including BUTRANS 10 mcg/hour transdermal patch (10 mg, Transdermal patch, SAR 173.65); BUTRANS 20 mcg/hour transdermal patch (20 mg, Transdermal patch, SAR 301.95); BUTRANS 5 mcg/hour transdermal patch (5 mg, Transdermal patch, SAR 95.50); Buvidal (8 mg, Solution for injection, SAR 333.85); Buvidal (16 mg, Solution for injection, SAR 333.85).

Is Buprenorphine approved by the US FDA?

Drugs@FDA lists 28 application product lines for Buprenorphine, including BUPRENORPHINE HYDROCHLORIDE (Prescription); BUPRENORPHINE HYDROCHLORIDE (Prescription); BUPRENORPHINE HYDROCHLORIDE (Prescription); BUTRANS (Prescription); BUPRENORPHINE HYDROCHLORIDE (Prescription).

Is Buprenorphine authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Buprenorphine: Buvidal, Buprenorphine Neuraxpharm.

Is Buprenorphine on the WHO Model List of Essential Medicines?

Yes — 24.5.3. Medicines for opioid use disorders (complementary list): Therapeutic equivalent to methadone for Opioid dependence.

Are there safety signals or safety updates for Buprenorphine?

EMA PRAC: 2 entries; US FDA: 12 entries (latest 2025-12-22).

Active substance

Buprenorphine

SFDA 10
US FDA 28
EMA 3
Health Canada 6
US price lines 19
NHS prices 25
WHO EML 1
Safety 14

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
BUTRANS 10 mcg/hour transdermal patch	10 mg	Transdermal patch · Transdermal use	4 Pouch	SAR 173.65	NCE · Prescription	Napp pharmacuticals limited UK	Valid
BUTRANS 20 mcg/hour transdermal patch	20 mg	Transdermal patch · Transdermal use	4 Pouch	SAR 301.95	NCE · Prescription	Napp pharmacuticals limited UK	Valid
BUTRANS 5 mcg/hour transdermal patch	5 mg	Transdermal patch · Transdermal use	4 Pouch	SAR 95.50	NCE · Prescription	Napp pharmacuticals limited UK	Valid
Buvidal	8 mg	Solution for injection · Subcutaneous use	1 Pre-filled syringe	SAR 333.85	NCE · Prescription	Camurus AB	Valid
Buvidal	16 mg	Solution for injection · Subcutaneous use	1 Pre-filled syringe	SAR 333.85	NCE · Prescription	Camurus AB	Valid
Buvidal	24 mg	Solution for injection · Subcutaneous use	1 Pre-filled syringe	SAR 333.85	NCE · Prescription	Camurus AB	Valid
Buvidal	32 mg	Solution for injection · Subcutaneous use	1 Pre-filled syringe	SAR 333.85	NCE · Prescription	Camurus AB	Valid
Buvidal	64 mg	Solution for injection · Subcutaneous use	1 Pre-filled syringe	SAR 1460.50	NCE · Prescription	Camurus AB	Valid
Buvidal	96 mg	Solution for injection · Subcutaneous use	1 Pre-filled syringe	SAR 1460.50	NCE · Prescription	Camurus AB	Valid
Buvidal	128 mg	Solution for injection · Subcutaneous use	1 Pre-filled syringe	SAR 1460.50	NCE · Prescription	Camurus AB	Valid

Indications — CHI Daman Drug Formulary

ANESTHESIA; BURN MANAGEMENT; ENTEROPATHIC ARTHROPATHIES, UNSPECIFIED SITE REACTIVE ARTHROPATHY, UNSPECIFIED; LOW BACK PAIN; PAIN MANAGEMENT IN CANCER PATIENTS; SICKLE CELL DISEASE - PAIN MANAGEMENT

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	injectable · injection	HOSPIRA	Prescription	3 Jun 1996
BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	injectable · injection	HIKMA PHARMS	Prescription	2 Mar 2005
BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE; EQ 8MG BASE	tablet · sublingual	HIKMA PHARMS	Prescription	8 Oct 2009
BUTRANS	5MCG/HR; 10MCG/HR; 20MCG/HR; 15MCG/HR; 7.5MCG/HR	film, extended release · transdermal	KNOA PHARMA	Prescription	30 Jun 2010
BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE; EQ 8MG BASE	tablet · sublingual	ETHYPHARM	Prescription	24 Sep 2010
BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE; EQ 8MG BASE	tablet · sublingual	ACTAVIS ELIZABETH	Prescription	19 Feb 2015
BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE; EQ 8MG BASE; EQ 4MG BASE; EQ 12MG BASE	tablet · sublingual	RUBICON RESEARCH	Prescription	10 Jun 2015
BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	injectable · injection	PH HEALTH	Prescription	28 Jul 2015
BELBUCA	EQ 0.075MG BASE; EQ 0.15MG BASE; EQ 0.3MG BASE; EQ 0.45MG BASE; EQ 0.6MG BASE; EQ 0.75MG BASE; EQ 0.9MG BASE	film · buccal	BDSI	Prescription	23 Oct 2015
BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE; EQ 8MG BASE	tablet · sublingual	SUN PHARM	Prescription	29 Jan 2016
BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE; EQ 8MG BASE	tablet · sublingual	RHODES PHARMS	Prescription	27 Mar 2017
SUBLOCADE	100MG/0.5ML (100MG/0.5ML); 300MG/1.5ML (200MG/ML)	solution, extended release · subcutaneous	INDIVIOR	Prescription	30 Nov 2017
BUPRENORPHINE	5MCG/HR; 10MCG/HR; 15MCG/HR; 20MCG/HR; 7.5MCG/HR	film, extended release · transdermal	WATSON LABS TEVA	Prescription	20 Nov 2018
BUPRENORPHINE	5MCG/HR; 7.5MCG/HR; 10MCG/HR; 15MCG/HR; 20MCG/HR	film, extended release · transdermal	AMNEAL	Prescription	14 Apr 2020
BUPRENORPHINE	5MCG/HR; 7.5MCG/HR; 10MCG/HR; 15MCG/HR; 20MCG/HR	film, extended release · transdermal	DIFGEN PHARMS	Prescription	23 Sep 2021
BUPRENORPHINE	5MCG/HR; 10MCG/HR; 15MCG/HR; 20MCG/HR	film, extended release · transdermal	STRIDES PHARMA INTL	Prescription	17 May 2022
BRIXADI	8MG/0.16ML (50MG/ML); 16MG/0.32ML (50MG/ML); 24MG/0.48ML (50MG/ML); 32MG/0.64ML (50MG/ML); 64MG/0.18ML (356MG/ML); 96MG/0.27ML (356MG/ML); 128MG/0.36ML (356MG/ML)	solution, extended release · subcutaneous	BRAEBURN	Prescription	23 May 2023
BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	injectable · injection	SOMERSET THERAPS LLC	Prescription	30 Jan 2025
BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE; EQ 8MG BASE	tablet · sublingual	SPECGX LLC	Prescription	10 Dec 2025
BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE; EQ 8MG BASE	tablet · sublingual	ASCENT PHARMS INC	Prescription	18 Dec 2025
BUPRENEX	EQ 0.3MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	injectable · injection	INDIVIOR	Discontinued	29 Dec 1981
SUBUTEX	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · sublingual	INDIVIOR	Discontinued	8 Oct 2002
BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	injectable · injection	AM REGENT	Discontinued	27 Mar 2007
BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE; EQ 8MG BASE	tablet · sublingual	BARR	Discontinued	7 May 2010
BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE; EQ 8MG BASE	tablet · sublingual	QUAGEN	Discontinued	6 Mar 2015

3 more — full table

EMA European Union — centrally authorised medicines

Buvidal Camurus AB · Authorised · authorised 20 Nov 2018 · ATC N07BC01

Therapeutic indication (EMA)

Treatment of opioid dependence within a framework of medical, social and psychological treatment. Treatment is intended for use in adults and adolescents aged 16 years or over.

Buprenorphine Neuraxpharm Neuraxpharm Pharmaceuticals S.L. · Authorised · authorised 19 Dec 2024 · ATC N07BC01

Therapeutic indication (EMA)

Substitution treatment of opioid drug dependence, within a comprehensive therapeutic monitoring framework of medical, social and psychological treatment. Treatment is intended for use in adults and adolescents 15 years of age and older, who have agreed to be treated for addiction.

Sixmo L. Molteni & C. dei Fratelli Alitti Società di Esercizio S.p.A. · Withdrawn · authorised 19 Jun 2019 · ATC N07BC01

Therapeutic indication (EMA)

Sixmo is indicated for substitution treatment for opioid dependence in clinically stable adult patients who require no more than 8 mg/day of sublingual buprenorphine, within a framework of medical, social and psychological treatment.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
BUTRANS 10	02341212	10 MCG / HOUR	PATCH · TRANSDERMAL	PURDUE PHARMA
BUTRANS 15	02450771	15 MCG / HOUR	PATCH · TRANSDERMAL	PURDUE PHARMA
BUTRANS 20	02341220	20 MCG / HOUR	PATCH · TRANSDERMAL	PURDUE PHARMA
BUTRANS 5	02341174	5 MCG / HOUR	PATCH · TRANSDERMAL	PURDUE PHARMA
SUBLOCADE	02483084	100 MG / 0.5 ML	SOLUTION (EXTENDED-RELEASE) · SUBCUTANEOUS	INDIVIOR UK LIMITED
SUBLOCADE	02483092	300 MG / 1.5 ML	SOLUTION (EXTENDED-RELEASE) · SUBCUTANEOUS	INDIVIOR UK LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	BELBUCA 150 MCG FILM	$7.55761	per EA	23 Sep 2026
US NADAC	BELBUCA 300 MCG FILM	$11.85628	per EA	23 Sep 2026
US NADAC	BELBUCA 450 MCG FILM	$16.1142	per EA	23 Sep 2026
US NADAC	BELBUCA 600 MCG FILM	$17.19033	per EA	23 Sep 2026
US NADAC	BELBUCA 75 MCG FILM	$7.54173	per EA	23 Sep 2026
US NADAC	BELBUCA 750 MCG FILM	$18.09899	per EA	23 Sep 2026
US NADAC	BELBUCA 900 MCG FILM	$18.59055	per EA	23 Sep 2026
US NADAC	BUPRENORPHINE 10 MCG/HR PATCH	$32.52934	per EA	23 Sep 2026
US NADAC	BUPRENORPHINE 15 MCG/HR PATCH	$53.7821	per EA	23 Sep 2026
US NADAC	BUPRENORPHINE 2 MG TABLET SL	$0.27676	per EA	23 Sep 2026
US NADAC	BUPRENORPHINE 20 MCG/HR PATCH	$58.8288	per EA	23 Sep 2026
US NADAC	BUPRENORPHINE 5 MCG/HR PATCH	$23.44849	per EA	23 Sep 2026
NHS Drug Tariff	Buprenorphine 10micrograms/hour transdermal patches	£31.55	4 patch	1 Oct 2026
NHS Drug Tariff	Buprenorphine 128mg/0.36ml prolonged-release solution for injection pre-filled syringes	£239.70	1 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Buprenorphine 15micrograms/hour transdermal patches	£49.15	4 patch	1 Oct 2026
NHS Drug Tariff	Buprenorphine 160mg/0.45ml prolonged-release solution for injection pre-filled syringes	£239.70	1 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Buprenorphine 16mg/0.32ml prolonged-release solution for injection pre-filled syringes	£55.93	1 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Buprenorphine 200microgram sublingual tablets sugar free	£5.04	50 tablet	1 Oct 2026
NHS Drug Tariff	Buprenorphine 20micrograms/hour transdermal patches	£57.46	4 patch	1 Oct 2026
NHS Drug Tariff	Buprenorphine 24mg/0.48ml prolonged-release solution for injection pre-filled syringes	£55.93	1 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Buprenorphine 25micrograms/hour transdermal patches	£31.70	4 patch	1 Oct 2026
NHS Drug Tariff	Buprenorphine 2mg oral lyophilisates sugar free	£12.70	28 tablet	1 Oct 2026
NHS Drug Tariff	Buprenorphine 2mg sublingual tablets sugar free	£1.33	7 tablet	1 Oct 2026
NHS Drug Tariff	Buprenorphine 30micrograms/hour transdermal patches	£38.04	4 patch	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

WHO WHO Model List of Essential Medicines (2025)

24.5.3. Medicines for opioid use disorders · complementary
Therapeutic equivalent to methadone for Opioid dependence

Safety signals and safety-related labeling changes

US FDA 22 Dec 2025 BELBUCA — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 22 Dec 2025 BUTRANS — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 22 Dec 2025 SUBOXONE — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 22 Dec 2025 ZUBSOLV — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 22 Dec 2025 BRIXADI — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 22 Dec 2025 PROBUPHINE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 22 Dec 2025 SUBLOCADE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 15 Dec 2023 BUPRENEX — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations
US FDA 15 Dec 2023 CASSIPA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 17 Jun 2022 BUNAVAIL — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 17 Jun 2022 SUBUTEX — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 17 Jun 2022 SUBOXONE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 14 May 2020 PRAC signal: Drug-drug interaction with serotonergic drugs leading to serotonin syndrome
Action for MAH: update of the product information: Yes
EMA PRAC 12 Mar 2020 PRAC signal: Drug-drug interaction with serotonergic drugs leading to serotonin syndrome
Action for MAH: update of the product information: No

All safety entries for buprenorphine →

Combinations containing Buprenorphine

Buprenorphine + naloxone

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.