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Innovar, Ionsys(fentanyl)
Actiq, Duragesic, Effentora, Fentora, Innovar, Instanyl, Ionsys, PecFent, Sublimaze, Subsys (fentanyl) is a small molecule pharmaceutical. Fentanyl was first approved as Innovar on 1982-01-01. It is used to treat pain in the USA. It has been approved in Europe to treat neoplasms, pain, and postoperative pain. The pharmaceutical is active against mu-type opioid receptor. In addition, it is known to target kappa-type opioid receptor and delta-type opioid receptor.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
signs and symptoms pathological conditionsD013568
psychological phenomenaD011579
musculoskeletal and neural physiological phenomenaD055687
Trade Name
FDA
EMA
Actiq, Fentora, Sublimaze (generic drugs available since 1991-09-24, discontinued: Abstral, Duragesic, Ionsys, Lazanda, Onsolis, Subsys)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Droperidol
+
Fentanyl citrate
Tradename
Company
Number
Date
Products
INNOVARAkornN-016049 DISCN1982-01-01
1 products
Hide discontinued
Fentanyl
Tradename
Company
Number
Date
Products
SUBSYSMMB HealthcareN-202788 DISCN2012-01-04
7 products, RLD
DURAGESIC-37Johnson & JohnsonN-019813 DISCN2018-01-24
1 products, RLD
DURAGESIC-12Johnson & JohnsonN-019813 DISCN2005-02-04
1 products, RLD
DURAGESIC-100Johnson & JohnsonN-019813 DISCN1990-08-07
1 products, RLD
DURAGESIC-75Johnson & JohnsonN-019813 DISCN1990-08-07
1 products, RLD
DURAGESIC-50Johnson & JohnsonN-019813 DISCN1990-08-07
1 products, RLD
DURAGESIC-25Johnson & JohnsonN-019813 DISCN1990-08-07
1 products, RLD
Hide discontinued
Fentanyl citrate
Tradename
Company
Number
Date
Products
SUBLIMAZE PRESERVATIVE FREEAkornN-016619 RX1982-01-01
1 products, RLD, RS
ACTIQCephalonN-020747 RX1998-11-04
6 products, RLD
FENTORACephalonN-021947 RX2006-09-25
5 products, RLD
FENTANYL CITRATEExela Pharma SciencesN-215870 RX2023-02-08
2 products, RLD, RS
FENTANYL CITRATEHikma PharmaceuticalsN-019101 RX1984-07-11
2 products, RLD, RS
FENTANYL CITRATEHospiraN-019115 RX1985-01-12
1 products
Show 5 discontinued
Fentanyl hydrochloride
Tradename
Company
Number
Date
Products
IONSYSThe Medicines CompanyN-021338 DISCN2006-05-22
1 products, RLD
Hide discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
abstralNew Drug Application2014-11-30
actiqNew Drug Application2021-03-09
fentoraNew Drug Application2021-03-09
instanylExport only2019-09-17
lazandaNew Drug Application2021-03-31
subsysNew Drug Application2021-05-04
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
painEFO_0003843D010146R52
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Fentanyl Hydrochloride, Ionsys, The Medicines Co
90957062033-02-03DP
84287092032-06-11DPU-736
84287082032-05-21U-736
87815712032-03-31DPU-736
97311212031-10-17DP
83012382031-09-30DP
93646562031-09-30U-736
69759022024-04-01DP
Fentanyl Citrate, Lazanda, Btcp Pharma
97318692032-01-26DP
82166042024-10-03U-767
88891762024-01-16U-767
90788142024-01-08DP
98147052024-01-08DP
Fentanyl, Subsys, Btcp Pharma
84869722030-04-27DP
84869732030-04-27U-55
88354592027-01-25DP
88354602027-01-25DPU-55
92419352027-01-25DP
92893872027-01-25DPU-55
96427972027-01-25DPU-55
96428442027-01-25DP
100164032027-01-25DP
106105232027-01-25DP
Fentanyl Citrate, Fentora, Cephalon
78628322028-06-15DP
78628332028-06-15DP
80928322024-12-30DP
81191582024-12-30DP
Fentanyl Citrate, Onsolis, Adalvo
95972882027-07-23DPU-767
ATC Codes
N: Nervous system drugs
— N01: Anesthetics
— N01A: Anesthetics, general
— N01AH: Opioid anesthetics
— N01AH01: Fentanyl
— N01AH51: Fentanyl, combinations
— N02: Analgesics
— N02A: Opioid analgesics
— N02AB: Phenylpiperidine derivatives, opioid analgesics
— N02AB03: Fentanyl
HCPCS
Code
Description
J1810
Injection, droperidol and fentanyl citrate, up to 2 ml ampule
J3010
Injection, fentanyl citrate, 0.1 mg
Clinical
Clinical Trials
822 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PainD010146EFO_0003843R52813333328112
Postoperative painD010149G89.18687352881
NeoplasmsD009369C80213203741
AnesthesiaD000758324111736
Labor painD04894931313928
Chronic painD059350HP_00125321297725
AnalgesiaD000698—184921
Acute painD059787R522239621
Cancer painD000072716G89.31174719
Healthy volunteers/patients—141—2117
Show 138 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Breast neoplasmsD001943EFO_0003869C50—11—24
Morbid obesityD009767EFO_0001074——1—34
Postpartum depressionD019052EFO_0007453F53.0—11—12
HypospadiasD007021EFO_0004209Q54—11—12
MucositisD052016EFO_1001898——2——2
Intractable painD010148—11——2
Traumatic brain injuriesD000070642S06—11——2
Complex regional pain syndromesD020918EFO_1001998——1—12
Pancreatic neoplasmsD010190EFO_0003860C25——1——1
Congenital cystic adenomatoid malformation of lungD015615——1——1
Show 24 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
DyspneaD004417HP_0002094R06.022——14
AnxietyD001007EFO_0005230F41.1—1——23
Heart failureD006333EFO_0003144I5011——13
Heart rateD006339EFO_0004326—1——12
ScoliosisD012600EFO_0004273M41—1———1
Referred painD053591—1———1
Radical mastectomyD01540911———1
Irritable bowel syndromeD043183EFO_0000555K58—1———1
Avulsion fracturesD00007156211———1
Bone fracturesD050723EFO_0003931T14.8—1———1
Show 13 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Emergence deliriumD0000712571———56
Biological availabilityD0016821———12
Near-infrared spectroscopyD0192651————1
PharmacokineticsD0105991————1
Infratentorial neoplasmsD015192C71.71————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Laparoscopic cholecystectomyD017081————33
Pre-eclampsiaD011225EFO_0000668O14————22
Lung diseasesD008171EFO_0003818J98.4————22
Renal insufficiencyD051437HP_0000083N19————22
CholecystectomyD002763————22
Breast diseasesD001941N60-N65————22
Pleural effusionD010996J90————22
Nociceptive painD059226————22
Female genital diseasesD005831EFO_0009549N85————22
LeukemiaD007938C95————22
Show 76 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameFENTANYL
INNfentanyl
Description
Fentanyl is a monocarboxylic acid amide resulting from the formal condensation of the aryl amino group of N-phenyl-1-(2-phenylethyl)piperidin-4-amine with propanoic acid. It has a role as an opioid analgesic, a mu-opioid receptor agonist, an anaesthesia adjuvant, an intravenous anaesthetic, an adjuvant and an anaesthetic. It is a member of piperidines, an anilide and a monocarboxylic acid amide.
Classification
Small molecule
Drug classOpioid
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1
Identifiers
PDB5TZO
CAS-ID437-38-7
RxCUI4337
ChEMBL IDCHEMBL596
ChEBI ID119915
PubChem CID3345
DrugBankDB00813
UNII IDUF599785JZ (ChemIDplus, GSRS)
Target
Agency Approved
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 (P42866)
Alternate
OPRK1
OPRK1
OPRD1
OPRD1
Organism
Homo sapiens
Gene name
OPRK1
Gene synonyms
OPRK
NCBI Gene ID
4986
Protein name
kappa-type opioid receptor
Protein synonyms
kappa opioid receptor, Opiate receptor, kappa-1
Uniprot ID
Q499G4
Mouse ortholog
Oprk1 (18387)
kappa-type opioid receptor (P33534)
Variants
Clinical Variant
No data
Financial
Subsys - Insys Therapeutics, Inc.
$
€
£
₣
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Lazanda - Assertio Therapeutics
$
€
£
₣
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Actiq - Cephalon
$
€
£
₣
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Fentora - Cephalon
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 50,825 documents
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Safety
Black-box Warning
Black-box warning for: Abstral, Actiq, Fentora, Lazanda, Subsys
Adverse Events
Top Adverse Reactions
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8,847 adverse events reported
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