Cocaine
Goprelto, Numbrino (cocaine) is a small molecule pharmaceutical. Cocaine was first approved as Goprelto on 2017-12-14. It is used to treat cough and pain in the USA. The pharmaceutical is active against sodium-dependent dopamine transporter.
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Commercial
Trade Name
FDA
EMA
Goprelto
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Cocaine hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| GOPRELTO | Noden Pharma | N-209963 RX | 2017-12-14 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| cocaine hydrochloride | NDA authorized generic | 2024-03-04 |
| cocaine hydrochloride nasal | NDA authorized generic | 2023-09-24 |
| goprelto | New Drug Application | 2024-11-06 |
| numbrino | New Drug Application | 2024-06-20 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| pain | EFO_0003843 | D010146 | R52 |
| cough | HP_0012735 | D003371 | R05 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
COCAINE HYDROCHLORIDE, NUMBRINO, CODY LABS INC | |||
| 2023-01-10 | NP | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Cocaine Hydrochloride, Goprelto, Genus Lifesciences | |||
| 9867815 | 2037-02-07 | U-2225, U-2226, U-2227 | |
| 10016407 | 2037-02-07 | U-2329 | |
| 10149843 | 2037-02-07 | U-2478, U-2479 | |
| 10231961 | 2037-02-07 | DP | |
| 10413505 | 2037-02-07 | U-2479 | |
| 10420760 | 2037-02-07 | U-2478 | |
| 10857095 | 2037-02-07 | U-3014 | |
| 10894012 | 2037-02-07 | U-3014 | |
| 10933060 | 2037-02-07 | U-3014 | |
| 10973811 | 2037-02-07 | U-2226 | |
| 10987347 | 2037-02-07 | U-2225 | |
| 11040032 | 2037-02-07 | DP | |
ATC Codes
N: Nervous system drugs
— N01: Anesthetics
— N01B: Local anesthetics
— N01BC: Esters of benzoic acid for local anesthesia
— N01BC01: Cocaine
R: Respiratory system drugs
— R02: Throat preparations
— R02A: Throat preparations
— R02AD: Local anesthetic throat preparations
— R02AD03: Cocaine
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01H: Local anesthetics, ophthalmologic
— S01HA: Local anesthetics
— S01HA01: Cocaine
— S02: Otologicals
— S02D: Other otologicals in atc
— S02DA: Analgesics and anesthetics
— S02DA02: Cocaine
HCPCS
Code | Description |
|---|---|
| C9046 | Cocaine hydrochloride nasal solution for topical administration, 1 mg |
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 |
|---|---|---|---|---|---|---|---|---|---|
| Cocaine-related disorders | D019970 | — | F14 | 133 | 212 | 27 | 15 | 111 | 468 |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | 13 | 29 | 12 | 7 | 42 | 97 |
| Addictive behavior | D016739 | EFO_0004347 | — | 6 | 12 | 3 | 3 | 23 | 44 |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | 4 | 12 | 3 | 1 | 8 | 26 |
| Syndrome | D013577 | — | — | — | — | — | 1 | 9 | 10 |
| Hiv | D006678 | — | — | 2 | — | — | 1 | 6 | 9 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | 1 | 1 | 1 | 3 | 1 | 6 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | — | 1 | — | 2 | 1 | 4 |
| Psychotic disorders | D011618 | — | F20.81 | — | — | — | 2 | 2 | 4 |
| Smoking | D012907 | EFO_0004318 | — | 1 | — | — | 1 | 1 | 3 |
Show 10 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | 6 | 19 | 4 | — | 21 | 49 |
| Attention deficit disorder with hyperactivity | D001289 | EFO_0003888 | F90 | 1 | 4 | 1 | — | 1 | 6 |
| Covid-19 | D000086382 | — | — | — | 1 | 1 | — | 5 | 6 |
| Hyperkinesis | D006948 | HP_0000752 | — | — | 4 | 1 | — | — | 4 |
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | — | 1 | 1 | — | 2 | 4 |
| Traumatic stress disorders | D040921 | — | — | — | 1 | 1 | — | 2 | 4 |
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | — | 1 | 1 | — | 1 | 3 |
| Prostatic neoplasms | D011471 | — | C61 | — | — | 1 | — | 1 | 2 |
| Sexually transmitted diseases | D012749 | — | A50-A64 | — | — | 1 | — | 1 | 2 |
| Blood transfusion | D001803 | — | — | — | 1 | 1 | — | 1 | 2 |
Show 7 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 6 | 1 | — | — | 5 | 11 |
| Heroin dependence | D006556 | EFO_0004240 | — | 1 | 2 | — | — | 6 | 9 |
| Impulsive behavior | D007175 | — | — | 1 | 2 | — | — | 5 | 8 |
| Recurrence | D012008 | — | — | 2 | 3 | — | — | 1 | 6 |
| Anxiety | D001007 | EFO_0005230 | F41.1 | — | 2 | — | — | 4 | 6 |
| Depression | D003863 | — | F33.9 | — | 5 | — | — | — | 5 |
| Alcohol drinking | D000428 | EFO_0004329 | — | 1 | 1 | — | — | 4 | 5 |
| Alcohol-related disorders | D019973 | — | F10 | 1 | 4 | — | — | — | 5 |
| Neoplasms | D009369 | — | C80 | 1 | 1 | — | — | 2 | 4 |
| Dyspnea | D004417 | HP_0002094 | R06.0 | — | 1 | — | — | 3 | 4 |
Show 22 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv infections | D015658 | EFO_0000764 | B20 | 1 | — | — | — | 6 | 7 |
| Infections | D007239 | EFO_0000544 | — | 2 | — | — | — | 2 | 4 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | 1 | — | — | — | 3 | 4 |
| Communicable diseases | D003141 | — | — | 1 | — | — | — | 2 | 3 |
| Amyotrophic lateral sclerosis | D000690 | HP_0007354 | G12.21 | 2 | — | — | — | 1 | 3 |
| Motor neuron disease | D016472 | EFO_0003782 | G12.2 | 2 | — | — | — | 1 | 3 |
| Sclerosis | D012598 | — | — | 2 | — | — | — | 1 | 3 |
| Intravenous infusions | D007262 | — | — | 3 | — | — | — | — | 3 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | 1 | — | — | — | 2 | 3 |
| Ischemia | D007511 | EFO_0000556 | — | 1 | — | — | — | 2 | 3 |
Show 31 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | — | — | — | — | 12 | 12 |
| Obstructive lung diseases | D008173 | HP_0006536 | — | — | — | — | — | 8 | 8 |
| Pain | D010146 | EFO_0003843 | R52 | — | — | — | — | 8 | 8 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 7 | 7 |
| Lung diseases | D008171 | HP_0002088 | J98.4 | — | — | — | — | 7 | 7 |
| Wounds and injuries | D014947 | — | T14.8 | — | — | — | — | 5 | 5 |
| Mental disorders | D001523 | EFO_0000677 | F91.9 | — | — | — | — | 5 | 5 |
| Asthma | D001249 | EFO_0000270 | J45 | — | — | — | — | 5 | 5 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | — | — | — | 5 | 5 |
| Tobacco use disorder | D014029 | — | F17 | — | — | — | — | 4 | 4 |
Show 190 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Cocaine |
| INN | — |
| Description | Cocaine is a tropane alkaloid obtained from leaves of the South American shrub Erythroxylon coca. It has a role as a local anaesthetic, a central nervous system stimulant, a sodium channel blocker, an adrenergic uptake inhibitor, a dopamine uptake inhibitor, a serotonin uptake inhibitor, a sympathomimetic agent, a vasoconstrictor agent, a xenobiotic, an environmental contaminant, a plant metabolite and a mouse metabolite. It is a methyl ester, a benzoate ester, a tertiary amino compound and a tropane alkaloid. It is a conjugate base of a cocaine(1+). |
| Classification | Small molecule |
| Drug class | local anesthetics |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | COC(=O)[C@H]1[C@@H](OC(=O)c2ccccc2)C[C@@H]2CC[C@H]1N2C |
Identifiers
| PDB | — |
| CAS-ID | 50-36-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL370805 |
| ChEBI ID | 27958 |
| PubChem CID | 446220 |
| DrugBank | DB00907 |
| UNII ID | — |
Target
Agency Approved
SLC6A3
SLC6A3
Organism
Homo sapiens
Gene name
SLC6A3
Gene synonyms
DAT1
NCBI Gene ID
Protein name
sodium-dependent dopamine transporter
Protein synonyms
DA transporter, dopamine transporter 1, solute carrier family 6 (neurotransmitter transporter), member 3, solute carrier family 6 (neurotransmitter transporter, dopamine), member 3, Solute carrier family 6 member 3
Uniprot ID
Mouse ortholog
Slc6a3 (13162)
sodium-dependent dopamine transporter (Q9R1I2)
Alternate
No data
Variants
No data
Financial
Revenue by drug
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Estimated US medical usage
Cocaine
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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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 22,397 documents
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Safety
Black-box Warning
Black-box warning for: Cocaine hydrochloride, Cocaine hydrochloride nasal, Goprelto, Numbrino
Adverse Events
Top Adverse Reactions
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15,306 adverse events reported
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