ozenoxacin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| antibacterials, nalidixic acid derivatives | 5058 | 245765-41-7 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Ozenoxacin is a quinolone antimicrobial drug. The mechanism of action involves the inhibition of bacterial DNA replication enzymes, DNA gyrase A and topoisomerase IV. Ozenoxacin has been shown to be bactericidal against S. aureus and S. pyogenes organisms. Ozenoxacin is used as topical treatment for impetigo and other infectious dermatological conditions.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Dec. 11, 2017 | FDA | FERRER INTERNACIONAL S.A. | |
| Sept. 28, 2015 | PMDA | Maruho Co., Ltd. |
FDA Adverse Event Reporting System (Female)
None
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
None
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | D06AX14 | DERMATOLOGICALS ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE ANTIBIOTICS FOR TOPICAL USE Other antibiotics for topical use |
| MeSH PA | D000900 | Anti-Bacterial Agents |
| MeSH PA | D000890 | Anti-Infective Agents |
| MeSH PA | D000970 | Antineoplastic Agents |
| MeSH PA | D004791 | Enzyme Inhibitors |
| MeSH PA | D059003 | Topoisomerase Inhibitors |
| FDA CS | M0023650 | Quinolones |
| FDA EPC | N0000175937 | Quinolone Antimicrobial |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Acne vulgaris | indication | 88616000 | |
| Superficial bacterial infection of skin | indication | 275441009 | |
| Staphylococcal infection of skin | indication | 402938009 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 6.46 | acidic |
| pKa2 | 5.8 | Basic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 1% | XEPI | FERRER INTERNACIONAL | N208945 | Dec. 11, 2017 | RX | CREAM | TOPICAL | 9399014 | Dec. 15, 2029 | TREATMENT OF IMPETIGO DUE TO STAPHYLOCOCCUS AUREUS OR STREPTOCOCCUS PYOGENES |
| 1% | XEPI | FERRER INTERNACIONAL | N208945 | Dec. 11, 2017 | RX | CREAM | TOPICAL | 9180200 | Jan. 29, 2032 | TREATMENT OF IMPETIGO DUE TO STAPHYLOCOCCUS AUREUS OR STREPTOCOCCUS PYOGENES |
Orange Book exclusivity data (new drug applications)
None
Bioactivity Summary:
None
External reference:
| ID | Source |
|---|---|
| V0LH498RFO | UNII |
| D09544 | KEGG_DRUG |
| 4037917 | VANDF |
| C2983945 | UMLSCUI |
| CHEBI:136050 | CHEBI |
| CHEMBL3990047 | ChEMBL_ID |
| 9863827 | PUBCHEM_CID |
| DB12924 | DRUGBANK_ID |
| 8788 | INN_ID |
| C000592413 | MESH_SUPPLEMENTAL_RECORD_UI |
| C464965 | MESH_SUPPLEMENTAL_RECORD_UI |
| 10841 | IUPHAR_LIGAND_ID |
| 1994739 | RXNORM |
| 267098 | MMSL |
| 33338 | MMSL |
| 017429 | NDDF |
| 763879001 | SNOMEDCT_US |
| 763887000 | SNOMEDCT_US |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Xepi | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70621-103 | CREAM | 10 mg | TOPICAL | NDA | 26 sections |
| Xepi | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70621-103 | CREAM | 10 mg | TOPICAL | NDA | 26 sections |