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Drug ReportsFentanyl
Sublimaze preservative free, Ionsys(fentanyl)
Effentora, Fentanyl, Innovar, Instanyl, Ionsys, PecFent, Sublimaze (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 delta-type opioid receptor and kappa-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
neoplasmsD009369
signs and symptoms pathological conditionsD013568
psychological phenomenaD011579
musculoskeletal and neural physiological phenomenaD055687
Trade Name
FDA
EMA
Fentanyl, Sublimaze (discontinued: Abstral, Actiq, Duragesic, Fentanyl, Fentora, 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)
Fentanyl
Tradename
Company
Number
Date
Products
SUBSYSMMB HealthcareN-202788 DISCN2012-01-04
7 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
DURAGESIC-12Johnson & JohnsonN-019813 DISCN2005-02-04
1 products, RLD
DURAGESIC-37Johnson & JohnsonN-019813 DISCN2018-01-24
1 products, RLD
Hide discontinued
Fentanyl citrate
Tradename
Company
Number
Date
Products
FENTANYL CITRATEHikma PharmaceuticalsN-019101 RX1984-07-11
2 products, RLD, RS
FENTANYL CITRATEHospiraN-019115 RX1985-01-12
1 products
SUBLIMAZE PRESERVATIVE FREERising PharmaceuticalsN-016619 RX1982-01-01
1 products, RLD, RS
Show 7 discontinued
Droperidol
+
Fentanyl citrate
Tradename
Company
Number
Date
Products
INNOVAREpic PharmaN-016049 DISCN1982-01-01
1 products
Hide discontinued
Fentanyl hydrochloride
Tradename
Company
Number
Date
Products
IONSYSThe Medicines CompanyN-021338 DISCN2006-05-22
1 products, RLD
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Labels
FDA
EMA
Brand Name
Status
Last Update
abstralNew Drug Application2014-11-30
fentanylANDA2026-04-07
fentanyl citrateNew Drug Application2026-08-24
fentanyl citrate, bupivacaine hclunapproved drug other2015-01-12
fentanyl systemANDA2026-03-02
fentanyl transdermalANDA2026-04-30
fentanyl transdermal systemANDA2018-06-05
fentanyl, bupivacaineunapproved drug other2012-08-16
lazandaNew Drug Application2021-03-31
sublimazeNew Drug Application2012-04-30
Show 2 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
painEFO_0003843D010146R52
psychotic disorders—D011618F20.81
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
2422 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Postoperative painD010149—G89.1810242591180324
PainD010146EFO_0003843R521320416061188
AnesthesiaD000758——62143293146
AgnosiaD000377EFO_0007136F8848132861108
AnalgesiaD000698——2516225294
Labor painD048949——345234579
Chronic painD059350——4517161858
NeoplasmsD009369—C803142191558
Acute painD059787—R52437182556
Emergence deliriumD000071257——332123351
Show 368 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pain managementD059408——232—712
Inguinal herniaD006552HP_0000023K40—22—811
Respiratory aspirationD053120EFO_1001839———2—911
HerniaD006547—K40-K46——1—89
Obstetrical anesthesiaD000773——112—36
HypospadiasD007021EFO_0004209Q54—12—35
IschemiaD007511EFO_0000556—221—25
Intervertebral disc degenerationD055959————1—34
Obstetric laborD007743———12—24
Vascular diseasesD014652EFO_0004264I77121—24
Show 60 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Substance-related disordersD019966EFO_0003890F13—2——79
Heart failureD006333EFO_0003144I5011——35
RecurrenceD012008———1——34
Brain ischemiaD002545EFO_0003883I67.82—1——34
Sleep initiation and maintenance disordersD007319—F51.01—1——23
Narcotic-related disordersD000079524———1——12
MastodyniaD059373EFO_1001366N64.4—1——12
Stress urinary incontinenceD014550———1——12
Ventricular heart septal defectsD006345—Q21.0—1——12
PulpitisD011671EFO_1001139K04.0—2———2
Show 36 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Opiate overdoseD000083682——2———1012
Drug overdoseD062787——1———89
Pre-eclampsiaD011225EFO_0000668O141———45
MastectomyD008408——1———45
Shoulder impingement syndromeD019534EFO_1001178M75.41———23
Biological availabilityD001682——2———13
SpondylosisD055009—M471———12
Tympanic membrane perforationD018058—H721———12
Respiration disordersD012120—J00-J991———12
PharmacokineticsD010599——1————1
Show 9 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Female genital diseasesD005831EFO_0009549N85————77
Aortic dissectionD000784—I71.0————66
Transurethral resection of prostateD020728——————66
Nociceptive painD059226——————66
Harm reductionD040261——————66
Femoral fracturesD005264—S72————55
Hip osteoarthritisD015207EFO_1000786M16————55
Renal insufficiencyD051437—N19————55
Inhalation anesthesiaD000769——————55
Spinal diseasesD013122—M45-M49————55
Show 341 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)Loading
Structure (InChI/SMILES or Protein Sequence)
CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1
Identifiers
PDB—
CAS-ID437-38-7
RxCUI—
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
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
Actiq – Cephalon
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Subsys – Insys Therapeutics
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Lazanda – Assertio Therapeutics
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Fentora – Cephalon
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Tabular view
Estimated US medical usage
Fentanyl
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 9,999 documents
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Safety
Black-box Warning
Black-box warning for: Abstral, Fentanyl, Fentanyl citrate, Fentanyl system, Fentanyl transdermal, Fentanyl transdermal system, Lazanda, Subsys, Transmucosal fentanyl citrate
Adverse Events
Top Adverse Reactions
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146,934 adverse events reported
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