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Drug ReportsSulbactam
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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Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
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Events
FDA approval date
EMA approval date
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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
infectionsD007239
skin and connective tissue diseasesD017437
Trade Name
FDA
EMA
Combinations
Ampicillin sulbactam, Unasyn, Xacduro (discontinued: Ampicillin sulbactam, Unasyn)
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
Tradename
Company
Number
Date
Products
UNASYNPfizerN-050608 RX1986-12-31
3 products, RLD, RS
Show 1 discontinued
Durlobactam sodium
+
Durlobactam sodium
+
Sulbactam sodium
Tradename
Company
Number
Date
Products
XACDURO (COPACKAGED)Entasis TherapeuticsN-216974 RX2023-05-23
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
ampicillin and sulbactamANDA2025-12-18
ampicillin sodium and sulbactam sodiumANDA2025-11-28
unasynNew Drug Application2025-05-14
xacduroNew Drug Application2025-11-26
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
respiratory tract infections—D012141J06.9
urinary tract infectionsEFO_0003103D014552N39.0
pneumococcal infectionsEFO_0000772D011008J13
infectious pregnancy complications—D011251—
bacterial infections—D001424A49
gonorrheaDOID_7551D006069A54
intraabdominal infections—D059413—
bacterial skin diseases—D017192—
escherichia coli infectionsEFO_1001318D004927B96.20
soft tissue infections—D018461—
Show 14 more
Agency Specific
FDA
EMA
Expiration
Code
DURLOBACTAM SODIUM / DURLOBACTAM SODIUM / SULBACTAM SODIUM, XACDURO (COPACKAGED), ENTASIS THERAP
2033-05-23GAIN
2028-05-23NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Durlobactam Sodium / Durlobactam Sodium / Sulbactam Sodium, Xacduro (Copackaged), Entasis Therap
99685932035-11-17DPU-2840
103764992035-11-17DPU-2840
93092452033-04-02DP
96230142033-04-02U-2840
ATC Codes
J: Antiinfectives for systemic use
— J01: Antibacterials for systemic use
— J01C: Beta-lactam antibacterials, penicillins
— J01CG: Beta-lactamase inhibitors, systemic penicillins
— J01CG01: Sulbactam
HCPCS
Code
Description
J0295
Injection, ampicillin sodium/sulbactam sodium, per 1.5 gm
Clinical
Clinical Trials
63 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Ventilator-associated pneumoniaD053717EFO_1001865J95.851——1——1
Iatrogenic diseaseD007049————1——1
BacteremiaD016470EFO_0003033R78.81——1——1
Acinetobacter infectionsD000151EFO_1000792———1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Urinary tract infectionsD014552EFO_0003103N39.0—1———1
PyelonephritisD011704EFO_1001141N10-N16—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InfectionsD007239EFO_0000544—2————2
Renal insufficiencyD051437—N191————1
Healthy volunteers/patients———1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameSulbactam
INNsulbactam
Description
Sulbactam is a member of penicillanic acids.
Classification
Small molecule
Drug classbeta-lactamase inhibitors
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Structure (InChI/SMILES or Protein Sequence)
CC1(C)[C@H](C(=O)O)N2C(=O)C[C@H]2S1(=O)=O
Identifiers
PDB—
CAS-ID68373-14-8
RxCUI—
ChEMBL IDCHEMBL403
ChEBI ID9321
PubChem CID130313
DrugBank—
UNII IDS4TF6I2330 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
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 21,412 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3,955 adverse events reported
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