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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
Hide discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
abstralNew Drug Application2014-11-30
fentanylANDA2025-08-07
fentanyl buccalNDA authorized generic2024-02-15
fentanyl citrateNew Drug Application2025-10-01
fentanyl citrate, bupivacaine hclunapproved drug other2015-01-12
fentanyl systemANDA2024-10-25
fentanyl transdermalANDA2024-05-08
fentanyl transdermal systemANDA2018-06-05
fentanyl, bupivacaineunapproved drug other2012-08-16
instanylExport only2024-11-27
Show 4 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
2212 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C80—2———2
DyspneaD004417—R06.0—2———2
Paroxysmal dyspneaD004418—I50.1—1———1
Indications Phases 1
No data
Indications Without Phase
No data
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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Lazanda – Assertio Therapeutics
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Subsys – Insys 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 67,756 documents
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Safety
Black-box Warning
Black-box warning for: Abstral, Fentanyl, Fentanyl buccal, Fentanyl citrate, Fentanyl system, Fentanyl transdermal, Fentanyl transdermal system, Lazanda, Subsys, Transmucosal fentanyl citrate
Adverse Events
Top Adverse Reactions
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144,094 adverse events reported
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