Buprenex, Suboxone(buprenorphine)

Belbuca, Brixadi, Buprenex, Butrans, Buvidal, Sixmo, Sublocade, Suboxone, Zubsolv (buprenorphine) is a small molecule pharmaceutical. Buprenorphine was first approved as Buprenex on 1982-01-01. It is used to treat heroin dependence and pain in the USA. It has been approved in Europe to treat opioid-related disorders. The pharmaceutical is active against mu-type opioid receptor and kappa-type opioid receptor.

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Therapeutic Areas

Therapeutic Area	MeSH
signs and symptoms pathological conditions	D013568
chemically-induced disorders	D064419
psychological phenomena	D011579
mental disorders	D001523
musculoskeletal and neural physiological phenomena	D055687

Trade Name

FDA

EMA

Belbuca, Brixadi, Buprenex, Butrans, Sublocade (generic drugs available since 1996-06-03, discontinued: Probuphine, Subutex)

Combinations

Suboxone, Zubsolv (generic drugs available since 1996-06-03, discontinued: Bunavail, Cassipa)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Buprenorphine

Tradename	Company	Number	Date	Products
BRIXADI	BRAEBURN	N-210136 RX	2023-05-23	7 products, RLD, RS
SUBLOCADE	Indivior	N-209819 RX	2017-11-30	2 products, RLD, RS
BUTRANS	Purdue Pharma	N-021306 RX	2010-06-30	5 products, RLD, RS

Buprenorphine hydrochloride

Tradename	Company	Number	Date	Products
BELBUCA	BioDelivery Sciences	N-207932 RX	2015-10-23	7 products, RLD, RS
BUPRENEX	Indivior	N-018401 RX	1982-01-01	1 products, RLD, RS

Show 2 discontinued

Buprenorphine hydrochloride

Naloxone hydrochloride

Tradename	Company	Number	Date	Products
SUBOXONE	Indivior	N-022410 RX	2010-08-30	4 products, RLD
ZUBSOLV	Orexo	N-204242 RX	2013-07-03	6 products, RLD

Show 3 discontinued

Labels

FDA

EMA

Brand Name	Status	Last Update
belbuca	New Drug Application	2021-07-29
brixadi	New Drug Application	2023-06-06
buprenex	New Drug Application	2019-10-07
buprenorphine hcl	ANDA	2023-06-16
butrans	New Drug Application	2021-03-01
sublocade	New Drug Application	2021-03-17
suboxone	New Drug Application	2021-03-17
zubsolv	New Drug Application	2021-03-01

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
heroin dependence	EFO_0004240	D006556	—
pain	EFO_0003843	D010146	R52

Agency Specific

FDA

EMA

No data

Patent Expiration

Patent	Expires	Flag	FDA Information
Buprenorphine, Sublocade, Indivior Inc
10646484	2038-06-22		U-2489
11000520	2035-11-06		U-3111
8921387	2032-01-06	DP	U-2173, U-2174
8975270	2031-09-05	DP	U-2175, U-2206
10558394	2031-06-25	DP
9272044	2031-06-06		U-2176, U-2177, U-2178, U-2209
9498432	2031-06-06	DP	U-2179
9782402	2031-06-06	DP	U-2176, U-2180, U-2207, U-2208
9827241	2031-06-06	DP	U-2174, U-2181, U-2206, U-2210, U-2211
10198218	2031-06-06		U-2489
10592168	2031-06-06		U-2489
Buprenorphine Hydrochloride / Naloxone Hydrochloride, Bunavail, Bdsi
9522188	2035-04-24	DP
8703177	2032-08-20	DP
Buprenorphine Hydrochloride, Belbuca, Bdsi
9901539	2032-12-21		U-1556
8147866	2027-07-23	DP	U-1521, U-1769
9655843	2027-07-23	DP	U-1556, U-2017
Buprenorphine Hydrochloride / Naloxone Hydrochloride, Zubsolv, Orexo Us Inc
8940330	2032-09-18	DP
9259421	2032-09-18	DP
9439900	2032-09-18	DP
10874661	2032-09-18	DP
10946010	2032-09-18	DP
11020387	2032-09-18	DP	U-3131
11020388	2032-09-18	DP	U-3131
11433066	2032-09-18		U-3131
8470361	2030-05-22	DP	U-1425
8658198	2027-12-03	DP	U-1494
Buprenorphine, Brixadi, Braeburn
9937164	2032-07-26	DP	U-3618
10912772	2032-07-26		U-3617
11110084	2032-07-26	DP	U-3616
11135215	2032-07-26	DP
8236292	2027-01-10	DP	U-3619
8236755	2026-07-31	DP	U-3620
8545832	2025-06-06	DP	U-3619
Buprenorphine Hydrochloride / Naloxone Hydrochloride, Suboxone, Indivior Inc
8475832	2030-03-26	DP	U-1411
9687454	2029-08-07	DP	U-1464
11135216	2029-08-07	DP	U-3111
8603514	2024-04-03	DP	U-1464
8017150	2023-02-13	DP
Buprenorphine Hydrochloride, Probuphine, Titan Pharms
7736665	2024-04-25		U-1878

ATC Codes

N: Nervous system drugs

— N02: Analgesics

— N02A: Opioid analgesics

— N02AE: Oripavine derivatives analgesics

— N02AE01: Buprenorphine

— N07: Other nervous system drugs in atc

— N07B: Drugs used in addictive disorders

— N07BC: Drugs used in opioid dependence

— N07BC01: Buprenorphine

— N07BC51: Buprenorphine, combinations

HCPCS

Code	Description
G2068	Medication assisted treatment, buprenorphine (oral); weekly bundle including dispensing and/or administration, substance use counseling, individual and group therapy, and toxicology testing if performed (provision of the services by a medicare-enrolled opioid treatment program)
G2069	Medication assisted treatment, buprenorphine (injectable); weekly bundle including dispensing and/or administration, substance use counseling, individual and group therapy, and toxicology testing if performed (provision of the services by a medicare-enrolled opioid treatment program)
G2070	Medication assisted treatment, buprenorphine (implant insertion); weekly bundle including dispensing and/or administration, substance use counseling, individual and group therapy, and toxicology testing if performed (provision of the services by a medicare-enrolled opioid treatment program)
G2071	Medication assisted treatment, buprenorphine (implant removal); weekly bundle including dispensing and/or administration, substance use counseling, individual and group therapy, and toxicology testing if performed (provision of the services by a medicare-enrolled opioid treatment program)
G2072	Medication assisted treatment, buprenorphine (implant insertion and removal); weekly bundle including dispensing and/or administration, substance use counseling, individual and group therapy, and toxicology testing if performed (provision of the services by a medicare-enrolled opioid treatment program)
G2079	Take-home supply of buprenorphine (oral); up to 7 additional day supply (provision of the services by a medicare-enrolled opioid treatment program); list separately in addition to code for primary procedure
J0570	Buprenorphine implant, 74.2 mg
J0571	Buprenorphine, oral, 1 mg
J0572	Buprenorphine/naloxone, oral, less than or equal to 3 mg buprenorphine
J0573	Buprenorphine/naloxone, oral, greater than 3 mg, but less than or equal to 6 mg buprenorphine

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Clinical

Clinical Trials

411 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Opioid-related disorders	D009293	EFO_0005611	F11	34	86	45	41	32	219
Substance-related disorders	D019966	EFO_0003890	F13	5	7	8	8	5	31
Pain	D010146	EFO_0003843	R52	6	3	9	6	3	26
Heroin dependence	D006556	EFO_0004240		4	5	7	2	2	18
Healthy volunteers/patients	—			12	—	—	2	4	18
Osteoarthritis	D010003	EFO_0002506	M15-M19	—	—	11	7	—	18
Chronic pain	D059350	HP_0012532		3	5	3	2	1	13
Hiv infections	D015658	EFO_0000764	B20	1	3	1	2	5	12
Postoperative pain	D010149		G89.18	2	3	2	3	2	12
Low back pain	D017116	HP_0003419	M54.5	—	—	9	3	—	12

Show 28 more

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Neonatal abstinence syndrome	D009357	EFO_0005799	P96.1	3	3	6	—	1	11
Cocaine-related disorders	D019970		F14	2	6	3	—	—	10
Pregnancy	D011247	EFO_0002950	Z33.1	—	1	1	—	2	4
Pregnancy rate	D018873			—	—	3	—	—	3
Knee osteoarthritis	D020370	EFO_0004616	M17	—	—	1	—	1	2
Neuralgia	D009437	EFO_0009430		—	—	1	—	1	2
Morphine dependence	D009021	EFO_0005612		—	—	2	—	—	2
Rotator cuff injuries	D000070636		M75.1	—	1	1	—	—	1
Spinal cord diseases	D013118	HP_0002196	G95.9	—	—	1	—	—	1
Depressive disorder	D003866	EFO_1002014	F32.A	—	—	1	—	—	1

Show 1 more

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Post-traumatic stress disorders	D013313	EFO_0001358	F43.1	—	2	—	—	1	3
Intravenous substance abuse	D015819			—	1	—	—	1	2
Drug interactions	D004347			1	1	—	—	—	1
Squamous cell carcinoma of head and neck	D000077195			—	1	—	—	—	1
Chronic kidney failure	D007676	EFO_0003884	N18.6	—	1	—	—	—	1
Inflammation	D007249			—	1	—	—	—	1
Alcoholism	D000437	EFO_0003829	F10.1	—	1	—	—	—	1
Sickle cell anemia	D000755	EFO_0000697	D57	—	1	—	—	—	1
Mucositis	D052016	EFO_1001898		1	1	—	—	—	1
Dental pins	D003772			—	1	—	—	—	1

Show 1 more

Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hepatitis c	D006526		B19.2	2	—	—	—	2	4
Respiratory insufficiency	D012131	HP_0002093	J96.9	1	—	—	—	—	1
Pharmacokinetics	D010599			1	—	—	—	—	1
Drug overdose	D062787			1	—	—	—	—	1
Infections	D007239	EFO_0000544		1	—	—	—	—	1
Hepacivirus	D016174			1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Risk reduction behavior	D040242			—	—	—	—	2	2
Complex regional pain syndromes	D020918	EFO_1001998		—	—	—	—	1	1
Cardiovascular diseases	D002318	EFO_0000319	I98	—	—	—	—	1	1
Morbid obesity	D009767	EFO_0001074		—	—	—	—	1	1
Addictive behavior	D016739	EFO_0004347		—	—	—	—	1	1
Chronic pancreatitis	D050500	EFO_0000342	K86.1	—	—	—	—	1	1

Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	BUPRENORPHINE
INN	buprenorphine
Description	Buprenorphine is a morphinane alkaloid that is 7,8-dihydromorphine 6-O-methyl ether in which positions 6 and 14 are joined by a -CH2CH2- bridge, one of the hydrogens of the N-methyl group is substituted by cyclopropyl, and a hydrogen at position 7 is substituted by a 2-hydroxy-3,3-dimethylbutan-2-yl group. It is highly effective for the treatment of opioid use disorder and is also increasingly being used in the treatment of chronic pain. It has a role as an opioid analgesic, a mu-opioid receptor agonist, a delta-opioid receptor antagonist and a kappa-opioid receptor antagonist.
Classification	Small molecule
Drug class	—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	CO[C@@]12CC[C@@]3(C[C@@H]1[C@](C)(O)C(C)(C)C)[C@H]1Cc4ccc(O)c5c4[C@@]3(CCN1CC1CC1)[C@H]2O5

Identifiers

PDB	—
CAS-ID	52485-79-7
RxCUI	1819
ChEMBL ID	CHEMBL511142
ChEBI ID	—
PubChem CID	644073
DrugBank	DB00921
UNII ID	40D3SCR4GZ (ChemIDplus, GSRS)

Target

Agency Approved

OPRM1

OPRK1

Organism

Homo sapiens

Gene name

OPRM1

Gene synonyms

MOR1

NCBI Gene ID

4988

Protein name

mu-type opioid receptor

Protein synonyms

hMOP, MOP, Mu opiate receptor, Mu opioid receptor, mu opioid receptor hMOR-1a

Uniprot ID

Q9UN57

Mouse ortholog

Oprm1 (18390)

mu-type opioid receptor (P42866)

Alternate

No data

Variants

Clinical Variant

No data

Financial

Bunavail - BioDelivery Sciences

€

₣

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Belbuca - BioDelivery Sciences

€

₣

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Belbuca - Collegium Pharmaceutical

€

₣

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Tabular view

Trends

PubMed Central

Top Terms for Disease or Syndrome:

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Additional graphs summarizing 38,383 documents

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Safety

Black-box Warning

Black-box warning for: Belbuca, Brixadi, Buprenex, Butrans, Sublocade

Adverse Events

Top Adverse Reactions

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12,033 adverse events reported

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Real-time Data on

Companies, Drugs, and Diseases

PharmaKB

MATERIALS

COMPANY