delafloxacin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| antibacterials, nalidixic acid derivatives | 5238 | 189279-58-1 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Delafloxacin belongs to the fluoroquinolone class of antibacterial drugs and is anionic in nature. The antibacterial activity of delafloxacin is due to the inhibition of both bacterial topoisomerase IV and DNA gyrase (topoisomerase II) enzymes which are required for bacterial DNA replication, transcription, repair, and recombination. Delafloxacin exhibits a concentration-dependent bactericidal activity against gram-positive and gram-negative bacteria in vitro.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 0.90 | g | O |
| 0.60 | g | P |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| Vd (Volume of distribution) | 0.35 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 2.33 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| fu (Fraction unbound in plasma) | 0.16 % | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 2.10 hours | Lombardo F, Berellini G, Obach RS |
| S (Water solubility) | 0.00 mg/mL | Bocci G, Oprea TI, Benet LZ |
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 4 | Bocci G, Oprea TI, Benet LZ |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Dec. 16, 2019 | EMA | A. Menarini Industrie Farmaceutiche Riunite s.r.l. | |
| June 19, 2017 | FDA | MELINTA THERAPEUTICS INC |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Diarrhoea | 67.81 | 63.01 | 23 | 29 | 715343 | 62773627 |
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 | J01MA23 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIBACTERIALS FOR SYSTEMIC USE QUINOLONE ANTIBACTERIALS Fluoroquinolones |
| FDA CS | M0372253 | Fluoroquinolones |
| MeSH PA | D000890 | Anti-Infective Agents |
| FDA EPC | N0000193223 | Fluoroquinolone Antibacterial |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Bacterial infection of skin | indication | 128936008 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 4.78 | acidic |
| pKa2 | 11.32 | acidic |
| pKa3 | 1.05 | Basic |
| pKa4 | 0.46 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 450MG BASE | BAXDELA | MELINTA | N208610 | June 19, 2017 | RX | TABLET | ORAL | 8648093 | Oct. 7, 2025 | TREATMENT OF ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS CAUSED BY DESIGNATED SUSCEPTIBLE BACTERIA IN ADULTS |
| EQ 450MG BASE | BAXDELA | MELINTA | N208610 | June 19, 2017 | RX | TABLET | ORAL | 8969569 | Oct. 7, 2025 | TREATMENT OF ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS CAUSED BY DESIGNATED SUSCEPTIBLE BACTERIA IN ADULTS |
| EQ 450MG BASE | BAXDELA | MELINTA | N208610 | June 19, 2017 | RX | TABLET | ORAL | 9539250 | Oct. 7, 2025 | TREATMENT OF ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS CAUSED BY DESIGNATED SUSCEPTIBLE BACTERIA IN ADULTS |
| EQ 300MG BASE/VIAL | BAXDELA | MELINTA | N208611 | June 19, 2017 | RX | POWDER | INTRAVENOUS | 8648093 | Oct. 7, 2025 | TREATMENT OF ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS CAUSED BY DESIGNATED SUSCEPTIBLE BACTERIA IN ADULTS |
| EQ 300MG BASE/VIAL | BAXDELA | MELINTA | N208611 | June 19, 2017 | RX | POWDER | INTRAVENOUS | 9539250 | Oct. 7, 2025 | TREATMENT OF ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS CAUSED BY DESIGNATED SUSCEPTIBLE BACTERIA IN ADULTS |
| EQ 450MG BASE | BAXDELA | MELINTA | N208610 | June 19, 2017 | RX | TABLET | ORAL | 8252813 | Oct. 2, 2026 | TREATMENT OF ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS CAUSED BY DESIGNATED SUSCEPTIBLE BACTERIA IN ADULTS |
| EQ 300MG BASE/VIAL | BAXDELA | MELINTA | N208611 | June 19, 2017 | RX | POWDER | INTRAVENOUS | 8252813 | Oct. 2, 2026 | TREATMENT OF ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS CAUSED BY DESIGNATED SUSCEPTIBLE BACTERIA IN ADULTS |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| EQ 450MG BASE | BAXDELA | MELINTA | N208610 | June 19, 2017 | RX | TABLET | ORAL | June 19, 2022 | NEW CHEMICAL ENTITY |
| EQ 300MG BASE/VIAL | BAXDELA | MELINTA | N208611 | June 19, 2017 | RX | POWDER | INTRAVENOUS | June 19, 2022 | NEW CHEMICAL ENTITY |
| EQ 450MG BASE | BAXDELA | MELINTA | N208610 | June 19, 2017 | RX | TABLET | ORAL | June 19, 2027 | GENERATING ANTIBIOTIC INCENTIVES NOW |
| EQ 300MG BASE/VIAL | BAXDELA | MELINTA | N208611 | June 19, 2017 | RX | POWDER | INTRAVENOUS | June 19, 2027 | GENERATING ANTIBIOTIC INCENTIVES NOW |
Bioactivity Summary:
None
External reference:
| ID | Source |
|---|---|
| 6315412YVF | UNII |
| 352458-37-8 | SECONDARY_CAS_RN |
| 4036880 | VANDF |
| C2828290 | UMLSCUI |
| CHEMBL2105637 | ChEMBL_ID |
| 487101 | PUBCHEM_CID |
| DB11943 | DRUGBANK_ID |
| D09330 | KEGG_DRUG |
| CHEMBL2105638 | ChEMBL_ID |
| 9064 | INN_ID |
| C405494 | MESH_SUPPLEMENTAL_RECORD_UI |
| 10799 | IUPHAR_LIGAND_ID |
| 258700 | MMSL |
| 32817 | MMSL |
| d08601 | MMSL |
| 017249 | NDDF |
| 017250 | NDDF |
| 735011001 | SNOMEDCT_US |
| 735012008 | SNOMEDCT_US |
| 763596009 | SNOMEDCT_US |
| 1927662 | RXNORM |
| C477891 | MESH_SUPPLEMENTAL_RECORD_UI |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Baxdela | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70842-101 | TABLET | 450 mg | ORAL | NDA | 33 sections |
| Baxdela | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70842-101 | TABLET | 450 mg | ORAL | NDA | 33 sections |
| Baxdela | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70842-102 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 300 mg | INTRAVENOUS | NDA | 33 sections |
| Baxdela | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70842-102 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 300 mg | INTRAVENOUS | NDA | 33 sections |