Clavulanic acid
Amoxicillin / Clavulanate Potassium, Augmentin, Timentin (clavulanic acid) is a small molecule pharmaceutical. Clavulanic acid was first approved as Augmentin '250' on 1984-08-06. It is used to treat haemophilus infections, otitis media, and staphylococcal infections in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| infections | D007239 |
| otorhinolaryngologic diseases | D010038 |
Trade Name
FDA
EMA
Combinations
Amoxicillin clavulanate potassium, Augmentin (discontinued: Amoxicillin clavulanate potassium, Augmentin, Timentin)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Amoxicillin
+
Clavulanate potassium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| AUGMENTIN '125' | USAntibiotics | N-050575 RX | 1984-08-06 | 1 products, RLD |
| AUGMENTIN '250' | USAntibiotics | N-050575 RX | 1984-08-06 | 1 products, RLD, RS |
| AUGMENTIN ES-600 | USAntibiotics | N-050755 RX | 2001-06-22 | 1 products, RLD |
| AUGMENTIN '875' | USAntibiotics | N-050720 RX | 1996-02-13 | 1 products, RLD |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| amoclan | 2009-01-07 | |
| amoxicillan and clavulanate potassium | ANDA | 2014-08-01 |
| amoxicillin | ANDA | 2020-06-19 |
| amoxicillin amoxicillin and clavulanate potassium | ANDA | 2024-01-09 |
| amoxicillin and clavulanate potassium | ANDA | 2025-01-02 |
| amoxicillin and clavulanate potassium extended release | New Drug Application | 2011-04-07 |
| amoxicillin clavulanate potassium | 2006-11-03 | |
| augmentin | New Drug Application | 2025-01-08 |
| augmentin es-600 | New Drug Application | 2024-08-28 |
| augmentinxr | New Drug Application | 2010-11-22 |
Indications
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Agency Specific
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Clinical
Clinical Trials
326 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infections | D007239 | EFO_0000544 | — | — | — | 4 | — | — | 4 |
| Communicable diseases | D003141 | — | — | — | — | 3 | — | — | 3 |
| Chronic bronchitis | D029481 | — | J42 | — | — | 1 | — | — | 1 |
| Bronchitis | D001991 | — | J40 | — | — | 1 | — | — | 1 |
| Acute disease | D000208 | — | — | — | — | 1 | — | — | 1 |
| Sinusitis | D012852 | EFO_0007486 | J32 | — | — | 1 | — | — | 1 |
| Maxillary sinusitis | D015523 | EFO_0007361 | J32.0 | — | — | 1 | — | — | 1 |
| Bacterial skin diseases | D017192 | — | — | — | — | 1 | — | — | 1 |
| Skin diseases | D012871 | — | L00-L99 | — | — | 1 | — | — | 1 |
| Otitis media | D010033 | EFO_0004992 | H66.9 | — | — | 1 | — | — | 1 |
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Indications Phases 2
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Indications Phases 1
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Indications Without Phase
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Clavulanic acid |
| INN | clavulanic acid |
| Description | Clavulanic acid is antibiotic isolated from Streptomyces clavuligerus. It acts as a suicide inhibitor of bacterial beta-lactamase enzymes. It has a role as an antibacterial drug, a bacterial metabolite, an anxiolytic drug and an EC 3.5.2.6 (beta-lactamase) inhibitor. It is a conjugate acid of a clavulanate. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | O=C(O)[C@H]1/C(=C/CO)O[C@@H]2CC(=O)N21 |
Identifiers
| PDB | — |
| CAS-ID | 58001-44-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL777 |
| ChEBI ID | 48947 |
| PubChem CID | 5280980 |
| DrugBank | DB00766 |
| UNII ID | 23521W1S24 (ChemIDplus, GSRS) |
Target
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Financial
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Estimated US medical usage
Clavulanic acid
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Amoxicillin
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Clavulanate
Total medical expenditures per year (USD, in millions)
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Trends
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Safety
Black-box Warning
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Adverse Events
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36,560 adverse events reported
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