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Drug ReportsNaloxone
Narcan, Suboxone(naloxone)
/ Naloxone, Kloxxado, Naloxone, Naloxone /, Narcan, Nyxoid, Rextovy, Rezenopy, Rivive, Suboxone, Targiniq, Zimhi, Zubsolv (naloxone) is a small molecule pharmaceutical. Naloxone was first approved as Narcan on 1982-01-01. It is used to treat opioid-related disorders, respiration disorders, and septic shock in the USA. It has been approved in Europe to treat opioid-related disorders. The pharmaceutical is active against delta-type opioid receptor and kappa-type opioid receptor. In addition, it is known to target mu-type opioid receptor.
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Events Timeline
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
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
respiratory tract diseasesD012140
signs and symptoms pathological conditionsD013568
chemically-induced disordersD064419
mental disordersD001523
Trade Name
FDA
EMA
Kloxxado, Naloxone, Narcan, Rextovy, Zimhi (discontinued: Evzio, Naloxone, Narcan)
Combinations
Buprenorphine naloxone, Naloxone pentazocine, Suboxone, Zubsolv (discontinued: Bunavail, Buprenorphine naloxone, Cassipa, Suboxone, Talwin, Targiniq)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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
Naloxone hydrochloride
+
Pentazocine hydrochloride
Tradename
Company
Number
Date
Products
TALWIN NXSanofiN-018733 DISCN1982-12-16
1 products
Hide discontinued
Naloxone hydrochloride
+
Oxycodone hydrochloride
Tradename
Company
Number
Date
Products
TARGINIQPurdue PharmaN-205777 DISCN2014-07-23
3 products, RLD
Hide discontinued
Naloxone hydrochloride
Tradename
Company
Number
Date
Products
ZIMHIDMK PharmaceuticalsN-212854 RX2021-10-15
1 products, RLD, RS
REXTOVYAmphastar PharmaceuticalsN-208969 RX2023-03-07
1 products, RLD, RS
NARCANEmergent xxxN-208411 OTC2015-11-18
1 products, RLD, RS
KLOXXADOHikma PharmaceuticalsN-212045 RX2021-04-29
1 products, RLD, RS
Show 5 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
buprenophine and naloxoneANDA2016-09-27
buprenorphine and naloxoneANDA2024-11-20
buprenorphine hcl and naloxone hclANDA2024-05-20
buprenorphine hydrochloride and naloxone hydrochloride dihydrateANDA2025-01-13
evzio(r) naloxone hclNew Drug Application2020-02-23
kloxxadoNew Drug Application2024-04-26
naloxoneNew Drug Application2023-12-12
naloxone hciANDA2024-01-27
naloxone hclANDA2024-01-28
naloxone hydrochlorideANDA2025-01-08
Show 13 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
septic shock—D012772A48.3
painEFO_0003843D010146R52
opioid-related disordersEFO_0005611D009293F11
heroin dependenceEFO_0004240D006556—
respiration disorders—D012120J00-J99
postoperative pain—D010149G89.18
Agency Specific
FDA
EMA
Expiration
Code
NALOXONE HYDROCHLORIDE, REXTOVY, AMPHASTAR PHARMS INC
2026-03-07NP
Patent Expiration
Patent
Expires
Flag
FDA Information
Naloxone Hydrochloride, Zimhi, Adamis Pharms Corp
115715182041-06-14DPU-3515, U-3516, U-3517
110270722039-05-24DP
Buprenorphine Hydrochloride / Naloxone Hydrochloride, Bunavail, Bdsi
95221882035-04-24DP
87031772032-08-20DP
81478662027-07-23DPU-1521
96558432027-07-23DPU-2017
Naloxone Hydrochloride, Evzio, Kaleo Inc
102201582035-03-20DPU-2500
95173072034-07-18DPU-1925
86278162032-02-04DP
101439722031-05-24U-2476
89399432031-02-28DP
90220222031-02-28DP
94748692031-02-28DPU-1907
103222392031-02-28U-1907
80213442029-11-02DP
82266102029-04-10DP
82315732028-11-25DP
77491942028-10-30DP
79470172028-03-12DP
97244712027-05-23DPU-2092
82063602027-02-27DP
92381082027-02-20DP
115902862026-12-12DP
109601552026-06-25DP
77316862026-06-10DP
89265942026-03-31DP
92781822026-02-01DP
103355492025-04-30DP
80167882025-03-21DP
77316902025-01-15DP
79188232024-11-23DP
83134662024-11-23DP
83610292024-11-23DP
84254622024-11-23DP
86086982024-11-23DP
90561702024-11-23DP
97376692024-11-23DP
103149772024-11-23DP
107370282024-11-23DP
Naloxone Hydrochloride, Narcan, Emergent
94806442035-03-16DPU-1903
97072262035-03-16DPU-1903
Naloxone Hydrochloride, Kloxxado, Hikma
107225102034-08-26DPU-3110
109738142034-08-26DPU-3110
111351552034-08-26DP
116177132034-08-26DPU-3110
116281392034-08-26DPU-3110
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
Naloxone Hydrochloride, Rivive, Harm Reduction Therp
110203432032-05-11U-3671
118064282032-05-11DP
Naloxone Hydrochloride, Evzio (Autoinjector), Kaleo Inc
101437922031-05-24U-2476
Naloxone Hydrochloride, Naloxone Hydrochloride (Autoinjector), Kaleo Inc
98148382031-02-28DP
Buprenorphine Hydrochloride / Naloxone Hydrochloride, Suboxone, Indivior
84758322030-03-26DPU-1411
96874542029-08-07DPU-1464
111352162029-08-07DPU-3111
86035142024-04-03DPU-1464
Show 1 more
ATC Codes
A: Alimentary tract and metabolism drugs
— A06: Drugs for constipation
— A06A: Drugs for constipation
— A06AH: Peripheral opioid receptor antagonists
— A06AH04: Naloxone
N: Nervous system drugs
— N02: Analgesics
— N02A: Opioid analgesics
— N02AA: Natural opium alkaloid analgesics
— N02AA53: Hydromorphone and naloxone
— N02AA55: Oxycodone and naloxone
— N02AX: Other opioids in atc
— N02AX51: Tilidine and naloxone
V: Various drug classes in atc
— V03: All other therapeutic products
— V03A: All other therapeutic products
— V03AB: Antidotes
— V03AB15: Naloxone
HCPCS
Code
Description
G1028
Take-home supply of nasal naloxone; 2-pack of 8mg per 0.1 ml nasal spray (provision of the services by a medicare-enrolled opioid treatment program); list separately in addition to code for primary procedure
G2215
Take-home supply of nasal naloxone; 2-pack of 4mg per 0.1 ml nasal spray (provision of the services by a medicare-enrolled opioid treatment program); list separately in addition to code for primary procedure
G2216
Take-home supply of injectable naloxone (provision of the services by a medicare-enrolled opioid treatment program); list separately in addition to code for primary procedure
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
J0574
Buprenorphine/naloxone, oral, greater than 6 mg, but less than or equal to 10 mg buprenorphine
J0575
Buprenorphine/naloxone, oral, greater than 10 mg buprenorphine
J2310
Injection, naloxone hydrochloride, per 1 mg
J2311
Injection, naloxone hydrochloride (zimhi), 1 mg
Clinical
Clinical Trials
530 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 disordersD009293EFO_0005611F113526319
Substance-related disordersD019966EFO_0003890F132—1227
Liver failureD017093HP_0001399K72.9———1—1
Hepatitis cD006526—B19.2———1—1
Chronic hepatitis cD019698EFO_0004220B18.2———1—1
Chronic hepatitis bD019694EFO_0004239B18.1———1—1
Hepatic insufficiencyD048550—————1—1
HepatitisD006505HP_0012115K75.9———1—1
Hepatic encephalopathyD006501—K72.91———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Heroin dependenceD006556EFO_0004240———1——1
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
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Opiate overdoseD000083682——————11
Drug overdoseD062787——————11
PainD010146EFO_0003843R52————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameNaloxone
INNnaloxone
Description
Naloxone is a synthetic morphinane alkaloid that is morphinone in which the enone double bond has been reduced to a single bond, the hydrogen at position 14 has been replaced by a hydroxy group, and the methyl group attached to the nitrogen has been replaced by an allyl group. A specific opioid antagonist, it is used (commonly as its hydrochloride salt) to reverse the effects of opioids, both following their use of opioids during surgery and in cases of known or suspected opioid overdose. It has a role as a mu-opioid receptor antagonist, a central nervous system depressant and an antidote to opioid poisoning. It is an organic heteropentacyclic compound, a morphinane alkaloid and a tertiary alcohol. It is a conjugate base of a naloxone(1+). It derives from a hydride of a morphinan.
Classification
Small molecule
Drug classnarcotic agonists/antagonists (normorphine type)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
C=CCN1CC[C@]23c4c5ccc(O)c4O[C@H]2C(=O)CC[C@@]3(O)[C@H]1C5
Identifiers
PDB—
CAS-ID465-65-6
RxCUI—
ChEMBL IDCHEMBL80
ChEBI ID7459
PubChem CID5284596
DrugBankDB01183
UNII ID36B82AMQ7N (ChemIDplus, GSRS)
Target
Agency Approved
OPRD1
OPRD1
OPRK1
OPRK1
Organism
Homo sapiens
Gene name
OPRD1
Gene synonyms
OPRD
NCBI Gene ID
4985
Protein name
delta-type opioid receptor
Protein synonyms
D-OR-1, delta opioid receptor 1, DOR-1
Uniprot ID
P41143
Mouse ortholog
Oprd1 (18386)
delta-type opioid receptor (P32300)
Alternate
OPRM1
OPRM1
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)
Variants
No data
Financial
Revenue by drug
$
€
£
₣
Naloxone – Amphastar Pharmaceuticals
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Bunavail – BioDelivery Sciences
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Estimated US medical usage
Naloxone
+
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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Naloxone
+
Pentazocine
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 32,889 documents
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Safety
Black-box Warning
Black-box warning for: Pentazocine and naloxone, Pentazocine hydrochloride and naloxone hydrochloride
Adverse Events
Top Adverse Reactions
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35,115 adverse events reported
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