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Drug ReportsBuprenorphine
Buprenex, Zubsolv(buprenorphine)
Belbuca, Brixadi, Buprenorphine, 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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Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
signs and symptoms pathological conditionsD013568
chemically-induced disordersD064419
psychological phenomenaD011579
mental disordersD001523
musculoskeletal and neural physiological phenomenaD055687
Trade Name
FDA
EMA
Belbuca, Buprenorphine, Butrans, Sublocade (discontinued: Buprenex, Buprenorphine, Subutex)
Combinations
Buprenorphine naloxone, Suboxone, Zubsolv (discontinued: Bunavail, Buprenorphine naloxone, Cassipa, Suboxone)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Buprenorphine
Tradename
Company
Number
Date
Products
SUBLOCADEIndiviorN-209819 RX2017-11-30
2 products, RLD, RS
BUTRANSPurdue PharmaN-021306 RX2010-06-30
5 products, RLD, RS
Buprenorphine hydrochloride
Tradename
Company
Number
Date
Products
BELBUCABioDelivery SciencesN-207932 RX2015-10-23
7 products, RLD, RS
Show 2 discontinued
Buprenorphine hydrochloride
+
Naloxone hydrochloride
Tradename
Company
Number
Date
Products
SUBOXONEIndiviorN-022410 RX2010-08-30
4 products, RLD
ZUBSOLVOrexoN-204242 RX2013-07-03
6 products, RLD
Show 3 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
belbucaNew Drug Application2023-12-21
brixadiNew Drug Application2025-01-09
buprenophine and naloxoneANDA2016-09-27
buprenorphineANDA2025-09-02
buprenorphine and naloxoneANDA2025-09-22
buprenorphine hclANDA2025-08-30
buprenorphine hcl and naloxone hclANDA2024-05-20
buprenorphine hydrochlorideANDA2025-05-28
buprenorphine hydrochloride and naloxone hydrochloride dihydrateANDA2025-09-24
buprenorphine hydrochloride sublingualANDA2017-09-15
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Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
painEFO_0003843D010146R52
heroin dependenceEFO_0004240D006556—
septic shock—D012772A48.3
opioid-related disordersEFO_0005611D009293F11
respiration disorders—D012120J00-J99
Agency Specific
FDA
EMA
Expiration
Code
BUPRENORPHINE, BRIXADI, BRAEBURN
2026-05-23NP
Patent Expiration
Patent
Expires
Flag
FDA Information
Buprenorphine, Sublocade, Indivior
106464842038-06-22U-2489
110005202035-11-06U-3111
118396112035-11-06U-3111
89213872032-01-06DPU-2173, U-2174
89752702031-09-05DPU-2175, U-2206
105583942031-06-25DP
92720442031-06-06U-2176, U-2177, U-2178, U-2209
94984322031-06-06DPU-2179
97824022031-06-06DPU-2176, U-2180, U-2207, U-2208
98272412031-06-06DPU-2174, U-2181, U-2206, U-2210, U-2211
101982182031-06-06U-2489
105921682031-06-06U-2489
Buprenorphine Hydrochloride / Naloxone Hydrochloride, Bunavail, Bdsi
95221882035-04-24DP
87031772032-08-20DP
Buprenorphine Hydrochloride, Belbuca, Bdsi
99015392032-12-21U-1556
81478662027-07-23DPU-1521, U-1769
96558432027-07-23DPU-1556, U-2017
Buprenorphine Hydrochloride / Naloxone Hydrochloride, Zubsolv, Orexo Us Inc
89403302032-09-18DP
92594212032-09-18DP
94399002032-09-18DP
108746612032-09-18DP
109460102032-09-18DP
110203872032-09-18DPU-3131
110203882032-09-18DPU-3131
114330662032-09-18U-3131
84703612030-05-22DPU-1425
86581982027-12-03DPU-1494
Buprenorphine, Brixadi, Braeburn
99371642032-07-26DPU-3618
109127722032-07-26U-3617
111100842032-07-26DPU-3616
111352152032-07-26DP
82362922027-01-10DPU-3619
82367552026-07-31DPU-3620
85458322025-06-06DPU-3619
Buprenorphine Hydrochloride / Naloxone Hydrochloride, Suboxone, Indivior
84758322030-03-26DPU-1411
96874542029-08-07DPU-1464
111352162029-08-07DPU-3111
86035142024-04-03DPU-1464
Buprenorphine Hydrochloride, Probuphine, Titan Pharms
77366652024-04-25U-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
753 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameBuprenorphine
INNbuprenorphine
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)Loading
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-ID52485-79-7
RxCUI—
ChEMBL IDCHEMBL511142
ChEBI ID—
PubChem CID644073
DrugBankDB00921
UNII ID40D3SCR4GZ (ChemIDplus, GSRS)
Target
Agency Approved
OPRM1
OPRM1
OPRK1
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 (Q9R1M0)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Belbuca – BioDelivery Sciences
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Belbuca – Collegium Pharmaceutical
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Bunavail – BioDelivery Sciences
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Tabular view
Estimated US medical usage
Buprenorphine
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Buprenorphine
+
Naloxone
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 50,919 documents
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Safety
Black-box Warning
Black-box warning for: Belbuca, Brixadi, Buprenorphine transdermal system, Butrans, Sublocade
Adverse Events
Top Adverse Reactions
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125,601 adverse events reported
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