Sufenta preservative free, Zalviso(sufentanil)
Dzuveo, Sufenta, Sufentanil (sufentanil) is a small molecule pharmaceutical. Sufentanil was first approved as Sufenta preservative free on 1984-05-04. It is used to treat pain in the USA. It has been approved in Europe to treat pain and postoperative pain. The pharmaceutical is active against mu-type opioid receptor.
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Commercial
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Trade Name
FDA
EMA
Sufenta, Sufentanil (discontinued: Dsuvia, Sufentanil)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Sufentanil citrate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| SUFENTA PRESERVATIVE FREE | Rising Pharmaceuticals | N-019050 RX | 1984-05-04 | 1 products, RLD, RS |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| dsuvia | New Drug Application | 2023-12-18 |
| sufenta | New Drug Application | 2010-11-15 |
| sufentanil citrate | ANDA | 2025-01-07 |
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 |
|---|---|---|---|
| Sufentanil Citrate, Dsuvia, Vertical Pharms | |||
| 11672738 | 2038-02-02 | DP | |
| 8945592 | 2031-07-29 | DP | |
| 8202535 | 2030-10-22 | U-1351 | |
| 8865743 | 2030-10-22 | U-1351 | |
| 8574189 | 2030-03-16 | DP | |
| 10896751 | 2030-03-16 | DP | |
| 11676691 | 2030-03-16 | DP | |
| 8226978 | 2027-01-05 | DP | U-1351 |
| 8231900 | 2027-01-05 | DP | |
| 8252328 | 2027-01-05 | DP | |
| 8252329 | 2027-01-05 | DP | |
| 8535714 | 2027-01-05 | DP | U-1351 |
| 8778393 | 2027-01-05 | U-1351 | |
| 8778394 | 2027-01-05 | U-1351 | |
| 8865211 | 2027-01-05 | U-1351 | |
| 9320710 | 2027-01-05 | U-1351 | |
| 9744129 | 2027-01-05 | DP | |
| 10245228 | 2027-01-05 | DP | U-1351 |
| 10342762 | 2027-01-05 | DP | |
| 10507180 | 2027-01-05 | DP | U-1351 |
HCPCS
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Clinical
Clinical Trials
503 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 pain | D010149 | — | G89.18 | 1 | 5 | 11 | 21 | 26 | 63 |
| Anesthesia | D000758 | — | — | 1 | 1 | 4 | 8 | 22 | 36 |
| Pain | D010146 | EFO_0003843 | R52 | 1 | 6 | 3 | 13 | 10 | 30 |
| Analgesia | D000698 | — | — | — | 3 | 2 | 6 | 15 | 26 |
| Delirium | D003693 | — | R41.0 | 2 | — | 1 | 6 | 9 | 18 |
| Labor pain | D048949 | — | — | — | 2 | 2 | 3 | 11 | 18 |
| Agnosia | D000377 | EFO_0007136 | F88 | — | 1 | 1 | 7 | 8 | 16 |
| Acute pain | D059787 | — | R52 | — | 1 | 4 | 6 | 3 | 14 |
| Emergence delirium | D000071257 | — | — | 2 | — | — | 5 | 7 | 14 |
| General anesthesia | D000768 | — | — | — | — | 1 | 2 | 7 | 10 |
Show 115 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Nerve block | D009407 | — | — | — | — | 1 | — | 5 | 6 |
| Local anesthesia | D000772 | — | — | — | — | 1 | — | 3 | 4 |
| Cough | D003371 | — | R05 | — | — | 1 | — | 2 | 3 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | — | — | 1 | — | 2 | 3 |
| Ischemia | D007511 | EFO_0000556 | — | 1 | 1 | 1 | — | 1 | 3 |
| Laparoscopy | D010535 | — | — | — | — | 1 | — | 1 | 2 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | — | — | 1 | — | 1 | 2 |
| Esophageal neoplasms | D004938 | — | C15 | — | 1 | 1 | — | 1 | 2 |
| Premedication | D011292 | — | — | — | 2 | 2 | — | — | 2 |
| Shoulder injuries | D000070599 | — | — | — | — | 1 | — | 1 | 2 |
Show 16 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | — | 1 | — | — | 5 | 6 |
| Hemorrhage | D006470 | MP_0001914 | R58 | 1 | 1 | — | — | 2 | 3 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | 1 | — | — | 1 | 2 |
| Anxiety | D001007 | EFO_0005230 | F41.1 | — | 1 | — | — | 1 | 2 |
| Prenatal diagnosis | D011296 | — | — | — | 1 | — | — | — | 1 |
| Fibrosis | D005355 | — | — | — | 1 | — | — | — | 1 |
| Craniocerebral trauma | D006259 | — | S00 | — | 1 | — | — | — | 1 |
| Hip prosthesis | D006622 | — | — | — | 1 | — | — | — | 1 |
| Pulpitis | D011671 | EFO_1001139 | K04.0 | — | 1 | — | — | — | 1 |
| Breakthrough pain | D059390 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Respiratory insufficiency | D012131 | — | J96.9 | 1 | — | — | — | 2 | 3 |
| Lung neoplasms | D008175 | — | C34.90 | 1 | — | — | — | 1 | 2 |
| Pharmacokinetics | D010599 | — | — | 2 | — | — | — | — | 2 |
| Biological availability | D001682 | — | — | 1 | — | — | — | — | 1 |
| Femur head necrosis | D005271 | — | — | 1 | — | — | — | — | 1 |
| Necrosis | D009336 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Nociceptive pain | D059226 | — | — | — | — | — | — | 4 | 4 |
| Colorectal neoplasms | D015179 | — | — | — | — | — | — | 4 | 4 |
| Nausea | D009325 | — | R11.0 | — | — | — | — | 3 | 3 |
| Hyperalgesia | D006930 | — | — | — | — | — | — | 3 | 3 |
| Individuality | D007206 | — | — | — | — | — | — | 3 | 3 |
| Airway management | D058109 | — | — | — | — | — | — | 3 | 3 |
| Gastrointestinal endoscopy | D016099 | — | — | — | — | — | — | 3 | 3 |
| Obstetrical analgesia | D016362 | — | — | — | — | — | — | 2 | 2 |
| Acute kidney injury | D058186 | — | N17 | — | — | — | — | 2 | 2 |
| Hip osteoarthritis | D015207 | EFO_1000786 | M16 | — | — | — | — | 2 | 2 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Sufentanil |
| INN | sufentanil |
| Description | Sufentanil is an anilide resulting from the formal condensation of the aryl amino group of 4-(methoxymethyl)-N-phenyl-1-[2-(2-thienyl)ethyl]piperidin-4-amine with propanoic acid. It has a role as an opioid analgesic, a mu-opioid receptor agonist, an anaesthesia adjuvant and an intravenous anaesthetic. It is a member of piperidines, a member of thiophenes, an anilide and an ether. |
| Classification | Small molecule |
| Drug class | narcotic analgesics (fentanyl derivatives) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCC(=O)N(c1ccccc1)C1(COC)CCN(CCc2cccs2)CC1 |
Identifiers
| PDB | — |
| CAS-ID | 56030-54-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL658 |
| ChEBI ID | 9316 |
| PubChem CID | 41693 |
| DrugBank | DB00708 |
| UNII ID | AFE2YW0IIZ (ChemIDplus, GSRS) |
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Safety
Black-box Warning
Black-box warning for: Dsuvia, Sufentanil citrate
Adverse Events
Top Adverse Reactions
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5,198 adverse events reported
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