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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Belbuca, Buprenorphine, Butrans, Sublocade (discontinued: Buprenex, Buprenorphine, Subutex)
CombinationsBuprenorphine 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 |
|---|---|---|---|---|
| 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 |
Show 2 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| belbuca | New Drug Application | 2023-12-21 |
| brixadi | New Drug Application | 2025-01-09 |
| buprenophine and naloxone | ANDA | 2016-09-27 |
| buprenorphine | ANDA | 2025-09-02 |
| buprenorphine and naloxone | ANDA | 2025-09-22 |
| buprenorphine hcl | ANDA | 2025-08-30 |
| buprenorphine hcl and naloxone hcl | ANDA | 2024-05-20 |
| buprenorphine hydrochloride | ANDA | 2025-05-28 |
| buprenorphine hydrochloride and naloxone hydrochloride dihydrate | ANDA | 2025-09-24 |
| buprenorphine hydrochloride sublingual | ANDA | 2017-09-15 |
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Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
BUPRENORPHINE, BRIXADI, BRAEBURN | |||
| 2026-05-23 | NP | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Buprenorphine, Sublocade, Indivior | |||
| 10646484 | 2038-06-22 | U-2489 | |
| 11000520 | 2035-11-06 | U-3111 | |
| 11839611 | 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 | |||
| 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 |
| 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
753 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 | 62 | 131 | 67 | 64 | 190 | 485 |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | 16 | 31 | 15 | 17 | 65 | 137 |
| Chronic pain | D059350 | — | — | 8 | 10 | 6 | 8 | 17 | 45 |
| Pain | D010146 | EFO_0003843 | R52 | 8 | 4 | 9 | 7 | 9 | 36 |
| Heroin dependence | D006556 | EFO_0004240 | — | 4 | 15 | 10 | 4 | 5 | 34 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 3 | 6 | 3 | 7 | 14 | 31 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | 1 | — | 13 | 7 | 2 | 23 |
| Healthy volunteers/patients | — | — | — | 15 | — | — | 2 | 6 | 23 |
| Addictive behavior | D016739 | EFO_0004347 | — | 5 | 4 | 1 | 4 | 10 | 21 |
| Depression | D003863 | — | F33.9 | 4 | 5 | 7 | 2 | 6 | 21 |
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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 | 4 | 4 | 6 | — | 7 | 18 |
| Cocaine-related disorders | D019970 | — | F14 | 3 | 9 | 3 | — | 2 | 16 |
| Pregnancy rate | D018873 | — | — | 1 | — | 4 | — | 3 | 8 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | 1 | 1 | — | 5 | 7 |
| Narcotic-related disorders | D000079524 | — | — | — | 2 | 1 | — | 4 | 7 |
| Infections | D007239 | EFO_0000544 | — | 1 | 2 | 1 | — | 1 | 5 |
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | — | — | 1 | — | 2 | 3 |
| Pancreatitis | D010195 | EFO_0000278 | K85 | — | 1 | 1 | — | 2 | 3 |
| Neuralgia | D009437 | EFO_0009430 | — | — | — | 2 | — | 1 | 3 |
| Disease | D004194 | EFO_0000408 | R69 | — | — | 1 | — | 1 | 2 |
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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 | — | 3 | — | — | 5 | 8 |
| Traumatic stress disorders | D040921 | — | — | — | 3 | — | — | 4 | 7 |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | — | 2 | — | — | 4 | 6 |
| Mucositis | D052016 | EFO_1001898 | — | 1 | 2 | — | — | — | 2 |
| Recreational drug use | D000084783 | — | — | — | 1 | — | — | 1 | 2 |
| Craving | D066249 | — | — | — | 1 | — | — | 1 | 2 |
| Patient compliance | D010349 | — | — | — | 1 | — | — | 1 | 2 |
| Dental pins | D003772 | — | — | — | 2 | — | — | — | 2 |
| Toothache | D014098 | — | K08.89 | — | 2 | — | — | — | 2 |
| Cigarette smoking | D000073865 | — | — | — | 1 | — | — | 1 | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Recurrence | D012008 | — | — | 2 | — | — | — | 2 | 4 |
| Pharmacokinetics | D010599 | — | — | 3 | — | — | — | — | 3 |
| Respiratory insufficiency | D012131 | — | J96.9 | 1 | — | — | — | 1 | 2 |
| Tissue adhesions | D000267 | — | — | 2 | — | — | — | — | 2 |
| Renal insufficiency | D051437 | — | N19 | 1 | — | — | — | — | 1 |
| Musculoskeletal pain | D059352 | — | — | 1 | — | — | — | — | 1 |
| Hepacivirus | D016174 | — | — | 1 | — | — | — | — | 1 |
| Inguinal hernia | D006552 | HP_0000023 | K40 | 1 | — | — | — | — | 1 |
| Hernia | D006547 | — | K40-K46 | 1 | — | — | — | — | 1 |
| Mindfulness | D064866 | — | — | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mental disorders | D001523 | EFO_0000677 | F91.9 | — | — | — | — | 3 | 3 |
| Treatment adherence and compliance | D000074822 | — | — | — | — | — | — | 3 | 3 |
| Anxiety disorders | D001008 | EFO_0006788 | F41.1 | — | — | — | — | 3 | 3 |
| Anxiety | D001007 | EFO_0005230 | F41.1 | — | — | — | — | 3 | 3 |
| Patient acceptance of health care | D010342 | — | — | — | — | — | — | 3 | 3 |
| Medication adherence | D055118 | EFO_0006344 | — | — | — | — | — | 3 | 3 |
| Risk reduction behavior | D040242 | — | — | — | — | — | — | 2 | 2 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | — | — | 2 | 2 |
| Immunologic deficiency syndromes | D007153 | — | D84.9 | — | — | — | — | 2 | 2 |
| Hyperalgesia | D006930 | — | — | — | — | — | — | 2 | 2 |
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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 | — |
| ChEMBL ID | CHEMBL511142 |
| ChEBI ID | — |
| PubChem CID | 644073 |
| DrugBank | DB00921 |
| UNII ID | 40D3SCR4GZ (ChemIDplus, GSRS) |
Target
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Belbuca – BioDelivery Sciences
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Belbuca – Collegium Pharmaceutical
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Bunavail – BioDelivery Sciences
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Estimated US medical usage
Buprenorphine
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Buprenorphine
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Naloxone
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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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