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 delta-type opioid receptor and kappa-type opioid receptor.
Download report
Favorite
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
Mock data
Subscribe for the real data
Subscribe for the real data
Commercial
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
Fentanyl
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| SUBSYS | MMB Healthcare | N-202788 DISCN | 2012-01-04 | 7 products, RLD |
| DURAGESIC-37 | Johnson & Johnson | N-019813 DISCN | 2018-01-24 | 1 products, RLD |
| DURAGESIC-12 | Johnson & Johnson | N-019813 DISCN | 2005-02-04 | 1 products, RLD |
| DURAGESIC-100 | Johnson & Johnson | N-019813 DISCN | 1990-08-07 | 1 products, RLD |
| DURAGESIC-75 | Johnson & Johnson | N-019813 DISCN | 1990-08-07 | 1 products, RLD |
| DURAGESIC-50 | Johnson & Johnson | N-019813 DISCN | 1990-08-07 | 1 products, RLD |
| DURAGESIC-25 | Johnson & Johnson | N-019813 DISCN | 1990-08-07 | 1 products, RLD |
Hide discontinued
Fentanyl citrate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| SUBLIMAZE PRESERVATIVE FREE | Akorn | N-016619 RX | 1982-01-01 | 1 products, RLD, RS |
| ACTIQ | Cephalon | N-020747 RX | 1998-11-04 | 6 products, RLD |
| FENTORA | Cephalon | N-021947 RX | 2006-09-25 | 5 products, RLD |
| FENTANYL CITRATE | Exela Pharma Sciences | N-215870 RX | 2023-02-08 | 2 products, RLD, RS |
| FENTANYL CITRATE | Hikma Pharmaceuticals | N-019101 RX | 1984-07-11 | 2 products, RLD, RS |
| FENTANYL CITRATE | Hospira | N-019115 RX | 1985-01-12 | 1 products |
Show 5 discontinued
Fentanyl hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| IONSYS | The Medicines Company | N-021338 DISCN | 2006-05-22 | 1 products, RLD |
Hide discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| abstral | New Drug Application | 2014-11-30 |
| actiq | New Drug Application | 2023-12-18 |
| fentanyl | ANDA | 2023-12-04 |
| fentanyl buccal | NDA authorized generic | 2023-03-29 |
| fentanyl citrate | New Drug Application | 2024-02-14 |
| fentanyl citrate, bupivacaine hcl | unapproved drug other | 2015-01-12 |
| fentanyl system | ANDA | 2024-01-18 |
| fentanyl transdermal | ANDA | 2023-05-17 |
| fentanyl transdermal system | ANDA | 2018-06-05 |
| fentanyl, bupivacaine | unapproved drug other | 2012-08-16 |
Show 6 more
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| pain | EFO_0003843 | D010146 | R52 |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Fentanyl Hydrochloride, Ionsys, The Medicines Co | |||
| 9095706 | 2033-02-03 | DP | |
| 8428709 | 2032-06-11 | DP | U-736 |
| 8428708 | 2032-05-21 | U-736 | |
| 8781571 | 2032-03-31 | DP | U-736 |
| 9731121 | 2031-10-17 | DP | |
| 8301238 | 2031-09-30 | DP | |
| 9364656 | 2031-09-30 | U-736 | |
| 6975902 | 2024-04-01 | DP | |
| Fentanyl Citrate, Lazanda, Btcp Pharma | |||
| 9731869 | 2032-01-26 | DP | |
| 8216604 | 2024-10-03 | U-767 | |
| 8889176 | 2024-01-16 | U-767 | |
| 9078814 | 2024-01-08 | DP | |
| 9814705 | 2024-01-08 | DP | |
| Fentanyl, Subsys, Btcp Pharma | |||
| 8486972 | 2030-04-27 | DP | |
| 8486973 | 2030-04-27 | U-55 | |
| 8835459 | 2027-01-25 | DP | |
| 8835460 | 2027-01-25 | DP | U-55 |
| 9241935 | 2027-01-25 | DP | |
| 9289387 | 2027-01-25 | DP | U-55 |
| 9642797 | 2027-01-25 | DP | U-55 |
| 9642844 | 2027-01-25 | DP | |
| 10016403 | 2027-01-25 | DP | |
| 10610523 | 2027-01-25 | DP | |
| Fentanyl Citrate, Fentora, Cephalon | |||
| 7862832 | 2028-06-15 | DP | |
| 7862833 | 2028-06-15 | DP | |
| 8092832 | 2024-12-30 | DP | |
| 8119158 | 2024-12-30 | DP | |
| Fentanyl Citrate, Onsolis, Adalvo | |||
| 9597288 | 2027-07-23 | DP | U-767 |
Clinical
Clinical Trials
1733 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Postoperative pain | D010149 | — | G89.18 | 7 | 14 | 11 | 52 | 91 | 172 |
| Pain | D010146 | EFO_0003843 | R52 | 10 | 16 | 36 | 40 | 53 | 152 |
| Anesthesia | D000758 | — | — | 4 | 2 | 10 | 25 | 64 | 104 |
| Analgesia | D000698 | — | — | 1 | 1 | 12 | 12 | 32 | 57 |
| Labor pain | D048949 | — | — | 3 | 2 | 3 | 19 | 30 | 56 |
| Neoplasms | D009369 | — | C80 | 2 | 14 | 21 | 3 | 10 | 46 |
| Chronic pain | D059350 | HP_0012532 | — | 1 | 2 | 12 | 11 | 12 | 37 |
| Acute pain | D059787 | — | R52 | 2 | 3 | 3 | 11 | 19 | 37 |
| Cesarean section | D002585 | — | — | 1 | 2 | — | 3 | 21 | 26 |
| Delirium | D003693 | — | R41.0 | — | 1 | — | 8 | 15 | 24 |
Show 219 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Postoperative complications | D011183 | — | — | — | — | 1 | — | 7 | 8 |
| Lung diseases | D008171 | HP_0002088 | J98.4 | — | — | 1 | — | 6 | 7 |
| Inguinal hernia | D006552 | HP_0000023 | K40 | — | — | 1 | — | 4 | 5 |
| Mastectomy | D008408 | — | — | 1 | — | 1 | — | 1 | 3 |
| Obstetrical anesthesia | D000773 | — | — | — | 1 | 2 | — | 1 | 3 |
| Hypospadias | D007021 | EFO_0004209 | Q54 | — | 1 | 1 | — | 2 | 3 |
| Heart rate | D006339 | EFO_0004326 | — | — | 2 | 1 | — | 1 | 3 |
| Mucositis | D052016 | EFO_1001898 | — | — | — | 2 | — | 1 | 3 |
| Pancreatitis | D010195 | HP_0001733 | K85 | 1 | 1 | 1 | — | — | 2 |
| Infratentorial neoplasms | D015192 | — | C71.7 | 1 | — | 1 | — | — | 2 |
Show 43 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Anxiety | D001007 | EFO_0005230 | F41.1 | — | 1 | — | — | 5 | 6 |
| Dyspnea | D004417 | HP_0002094 | R06.0 | 2 | 2 | — | — | 1 | 4 |
| Heart failure | D006333 | HP_0001635 | I50 | 1 | 1 | — | — | 1 | 3 |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | — | 1 | — | — | 1 | 2 |
| Pregnancy rate | D018873 | — | — | — | 2 | — | — | — | 2 |
| Stress urinary incontinence | D014550 | HP_0010992 | — | — | 1 | — | — | 1 | 2 |
| Brain ischemia | D002545 | EFO_0003883 | I67.82 | — | 1 | — | — | 1 | 2 |
| Premature birth | D047928 | EFO_0003917 | O60 | 1 | 1 | — | — | 1 | 2 |
| Heroin dependence | D006556 | EFO_0004240 | — | — | 1 | — | — | — | 1 |
| Scoliosis | D012600 | EFO_0004273 | M41 | — | 1 | — | — | — | 1 |
Show 22 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Colorectal neoplasms | D015179 | — | — | 1 | — | — | — | 3 | 4 |
| Biological availability | D001682 | — | — | 1 | — | — | — | 1 | 2 |
| Pharmacokinetics | D010599 | — | — | 1 | — | — | — | — | 1 |
| Supratentorial neoplasms | D015173 | — | C71.0 | 1 | — | — | — | — | 1 |
| Spinal fractures | D016103 | EFO_0003902 | S12 | 1 | — | — | — | — | 1 |
| Catastrophization | D058443 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Female genital diseases | D005831 | EFO_0009549 | N85 | — | — | — | — | 6 | 6 |
| Nociceptive pain | D059226 | — | — | — | — | — | — | 6 | 6 |
| Pre-eclampsia | D011225 | EFO_0000668 | O14 | — | — | — | — | 4 | 4 |
| Laparoscopic cholecystectomy | D017081 | — | — | — | — | — | — | 4 | 4 |
| Inflammation | D007249 | MP_0001845 | — | — | — | — | — | 4 | 4 |
| Deep sedation | D054810 | — | — | — | — | — | — | 4 | 4 |
| Hip osteoarthritis | D015207 | EFO_1000786 | M16 | — | — | — | — | 3 | 3 |
| Breast diseases | D001941 | — | N60-N65 | — | — | — | — | 3 | 3 |
| Urinary retention | D016055 | HP_0000016 | R33 | — | — | — | — | 3 | 3 |
| Breast feeding | D001942 | — | — | — | — | — | — | 3 | 3 |
Show 164 more
Epidemiology
Epidemiological information for investigational and approved indications
View more details
Drug
General
| Drug common name | Fentanyl |
| INN | fentanyl |
| 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 class | Opioid |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1 |
Identifiers
| PDB | — |
| CAS-ID | 437-38-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL596 |
| ChEBI ID | 119915 |
| PubChem CID | 3345 |
| DrugBank | DB00813 |
| UNII ID | UF599785JZ (ChemIDplus, GSRS) |
Target
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
Fentora – Cephalon
Mock data
Subscribe for the real data
Subscribe for the real data
Mock data
Subscribe for the real data
Subscribe for the real data
Lazanda – Assertio Therapeutics
Mock data
Subscribe for the real data
Subscribe for the real data
Mock data
Subscribe for the real data
Subscribe for the real data
Actiq – Cephalon
Mock data
Subscribe for the real data
Subscribe for the real data
Mock data
Subscribe for the real data
Subscribe for the real data
Subsys – Insys Therapeutics
Mock data
Subscribe for the real data
Subscribe for the real data
Mock data
Subscribe for the real data
Subscribe for the real data
Tabular view
Estimated US medical usage
Fentanyl
Total medical expenditures per year (USD, in millions)
Mock data
Subscribe for the real data
Subscribe for the real data
Number of persons purchased
Mock data
Subscribe for the real data
Subscribe for the real data
Number of purchases
Mock data
Subscribe for the real data
Subscribe for the real data
Refill frequency
Mock data
Subscribe for the real data
Subscribe for the real data
Price per prescription (USD)
Mock data
Subscribe for the real data
Subscribe for the real data
Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 56,680 documents
View more details
Safety
Black-box Warning
Black-box warning for: Abstral, Actiq, Fentanyl, Fentanyl buccal, Fentanyl citrate, Fentanyl system, Fentanyl transdermal, Fentanyl transdermal system, Fentora, Lazanda, Subsys, Transmucosal fentanyl citrate
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
116,344 adverse events reported
View more details
© 2020-2023 Collaborative Drug Discovery Inc. (CDD) | Terms of Use