Sulbactam
Ampicillin / Sulbactam, Unasyn, Xacduro (sulbactam) is a small molecule pharmaceutical. Sulbactam was first approved as Unasyn on 1986-12-31. It is used to treat acinetobacter infections, bacterial skin diseases, escherichia coli infections, intraabdominal infections, and klebsiella infections amongst others in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| infections | D007239 |
| skin and connective tissue diseases | D017437 |
Trade Name
FDA
EMA
Combinations
Unasyn, Xacduro (generic drugs available since 1988-11-23)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ampicillin sodium
+
Sulbactam sodium
Durlobactam sodium
+
Durlobactam sodium
+
Sulbactam sodium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| XACDURO (COPACKAGED) | Entasis Therapeutics | N-216974 RX | 2023-05-23 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| ampicillin and sulbactam | ANDA | 2024-02-14 |
| ampicillin sodium and sulbactam sodium | ANDA | 2023-07-21 |
| unasyn | New Drug Application | 2023-11-06 |
| xacduro | New Drug Application | 2023-09-12 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
DURLOBACTAM SODIUM / DURLOBACTAM SODIUM / SULBACTAM SODIUM, XACDURO (COPACKAGED), ENTASIS THERAP | |||
| 2033-05-23 | GAIN | ||
| 2028-05-23 | NCE | ||
HCPCS
Code | Description |
|---|---|
| J0295 | Injection, ampicillin sodium/sulbactam sodium, per 1.5 gm |
Clinical
Clinical Trials
53 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Urinary tract infections | D014552 | EFO_0003103 | N39.0 | — | 2 | 1 | 3 | 2 | 8 |
| Respiratory tract infections | D012141 | — | J06.9 | — | 1 | — | 3 | 2 | 6 |
| Infections | D007239 | EFO_0000544 | — | 3 | — | 1 | 1 | — | 5 |
| Pneumonia | D011014 | EFO_0003106 | — | 1 | 1 | — | 1 | 2 | 4 |
| Wound infection | D014946 | — | — | — | — | — | 1 | 1 | 2 |
| Ventilator-associated pneumonia | D053717 | EFO_1001865 | J95.851 | — | — | 1 | 1 | — | 2 |
| Intraabdominal infections | D059413 | — | — | — | — | — | 2 | — | 2 |
| Cholelithiasis | D002769 | EFO_0004799 | K80 | — | — | — | 2 | — | 2 |
| Gonorrhea | D006069 | DOID_7551 | A54 | — | — | — | 1 | — | 1 |
| Open fractures | D005597 | — | — | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bacteremia | D016470 | EFO_0003033 | R78.81 | — | — | 1 | — | 2 | 3 |
| Pyelonephritis | D011704 | EFO_1001141 | N10-N16 | — | 1 | 1 | — | — | 2 |
| Lung abscess | D008169 | EFO_1001362 | J85.2 | — | — | 1 | — | 1 | 2 |
| Sepsis | D018805 | HP_0100806 | A41.9 | — | — | 1 | — | — | 1 |
| Mortality | D009026 | EFO_0004352 | — | — | — | 1 | — | — | 1 |
| Inflammation | D007249 | MP_0001845 | — | — | — | 1 | — | — | 1 |
| Iatrogenic disease | D007049 | — | — | — | — | 1 | — | — | 1 |
| Aspiration pneumonia | D011015 | EFO_1001399 | J69.0 | — | — | 1 | — | — | 1 |
| Bacterial pneumonia | D018410 | EFO_1001272 | J15.9 | — | — | 1 | — | — | 1 |
| Chorioamnionitis | D002821 | — | O41.12 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cleft palate | D002972 | HP_0000175 | Q35 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Osteomyelitis | D010019 | EFO_0003102 | M86 | 1 | — | — | — | — | 1 |
| Jaw fractures | D007572 | — | — | 1 | — | — | — | — | 1 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Peritonitis | D010538 | EFO_0008588 | K65 | — | — | — | — | 2 | 2 |
| Critical illness | D016638 | — | — | — | — | — | — | 1 | 1 |
| Asymptomatic infections | D058345 | — | — | — | — | — | — | 1 | 1 |
| Bacteriuria | D001437 | — | R82.71 | — | — | — | — | 1 | 1 |
| Appendicitis | D001064 | EFO_0007149 | K37 | — | — | — | — | 1 | 1 |
| Cholecystitis | D002764 | HP_0001082 | K81 | — | — | — | — | 1 | 1 |
| Abdominal abscess | D018784 | EFO_1001753 | — | — | — | — | — | 1 | 1 |
| Pilonidal sinus | D010864 | HP_0010769 | L05 | — | — | — | — | 1 | 1 |
| Risk factors | D012307 | EFO_0003919 | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Sulbactam |
| INN | sulbactam |
| Description | Sulbactam is a member of penicillanic acids. |
| Classification | Small molecule |
| Drug class | beta-lactamase inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC1(C)[C@H](C(=O)O)N2C(=O)C[C@H]2S1(=O)=O |
Identifiers
| PDB | — |
| CAS-ID | 68373-14-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL403 |
| ChEBI ID | 9321 |
| PubChem CID | 130313 |
| DrugBank | — |
| UNII ID | S4TF6I2330 (ChemIDplus, GSRS) |
Target
No data
Variants
No data
Financial
Revenue by drug
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Xacduro – Innoviva
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Estimated US medical usage
Sulbactam
+
Ampicillin
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 16,851 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3,478 adverse events reported
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