oritavancin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 4678 | 171099-57-3 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
|
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| Vd (Volume of distribution) | 0.30 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 0.07 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| fu (Fraction unbound in plasma) | 0.13 % | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 96.20 hours | Lombardo F, Berellini G, Obach RS |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| March 19, 2015 | EMA | ||
| Aug. 6, 2014 | FDA | THE MEDICINES CO |
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 |
|---|---|---|---|---|---|---|
| Pruritus | 181.71 | 63.41 | 81 | 546 | 283487 | 50321010 |
| Urticaria | 94.73 | 63.41 | 41 | 586 | 129520 | 50474977 |
| Off label use | 82.90 | 63.41 | 58 | 569 | 474368 | 50130129 |
FDA Adverse Event Reporting System (Male)
| 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 |
|---|---|---|---|---|---|---|
| Off label use | 106.28 | 68.74 | 70 | 568 | 300730 | 29273159 |
| Chills | 76.80 | 68.74 | 35 | 603 | 71265 | 29502624 |
| Back pain | 73.39 | 68.74 | 38 | 600 | 102246 | 29471643 |
FDA Adverse Event Reporting System (Geriatric)
| 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 |
|---|---|---|---|---|---|---|
| Pruritus | 155.61 | 72.23 | 83 | 983 | 312317 | 64185349 |
| Off label use | 142.49 | 72.23 | 101 | 965 | 632705 | 63864961 |
| Urticaria | 120.22 | 72.23 | 55 | 1011 | 147262 | 64350404 |
| Chills | 95.62 | 72.23 | 46 | 1020 | 137218 | 64360448 |
| Infusion related reaction | 73.67 | 72.23 | 41 | 1025 | 164426 | 64333240 |
| Back pain | 72.26 | 72.23 | 47 | 1019 | 250124 | 64247542 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | J01XA05 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIBACTERIALS FOR SYSTEMIC USE OTHER ANTIBACTERIALS Glycopeptide antibacterials |
| FDA CS | M000640741 | Lipoglycopeptides |
| MeSH PA | D000900 | Anti-Bacterial Agents |
| MeSH PA | D000890 | Anti-Infective Agents |
| FDA MoA | N0000182140 | Cytochrome P450 2C19 Inhibitors |
| FDA MoA | N0000185504 | Cytochrome P450 2C9 Inhibitors |
| FDA MoA | N0000185506 | Cytochrome P450 3A4 Inducers |
| FDA MoA | N0000191267 | Cytochrome P450 2D6 Inducers |
| FDA EPC | N0000191281 | Lipoglycopeptide Antibacterial |
| CHEBI has role | CHEBI:33281 | antibiotics |
| CHEBI has role | CHEBI:36047 | antibacterial drugs |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Bacterial infection of skin | indication | 128936008 | |
| Streptococcal infection of skin | indication | 402937004 | |
| 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 | 2.05 | acidic |
| pKa2 | 7.69 | acidic |
| pKa3 | 10.72 | acidic |
| pKa4 | 11.48 | acidic |
| pKa5 | 11.49 | acidic |
| pKa6 | 12.17 | acidic |
| pKa7 | 12.41 | acidic |
| pKa8 | 13.03 | acidic |
| pKa9 | 13.04 | acidic |
| pKa10 | 13.67 | acidic |
| pKa11 | 9.27 | Basic |
| pKa12 | 8.57 | Basic |
| pKa13 | 8.3 | 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 400MG BASE/VIAL | ORBACTIV | MELINTA THERAP | N206334 | Aug. 6, 2014 | RX | POWDER | INTRAVENOUS | 8420592 | Aug. 29, 2029 | TREATMENT OF BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS USING A SINGLE DOSE |
| EQ 1.2GM BASE/VIAL | KIMYRSA | MELINTA THERAP | N214155 | March 12, 2021 | RX | POWDER | INTRAVENOUS | 8420592 | Aug. 29, 2029 | TREATMENT OF ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS WITH A SINGLE DOSE OF 1200MG ORITAVANCIN OR ITS SINGLE DOSE EQUIVALENT |
| EQ 400MG BASE/VIAL | ORBACTIV | MELINTA THERAP | N206334 | Aug. 6, 2014 | RX | POWDER | INTRAVENOUS | 9682061 | April 26, 2030 | TREATMENT OF BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS |
| EQ 1.2GM BASE/VIAL | KIMYRSA | MELINTA THERAP | N214155 | March 12, 2021 | RX | POWDER | INTRAVENOUS | 9682061 | April 26, 2030 | TREATMENT OF ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS WITH A SINGLE DOSE OF 1200MG ORITAVANCIN OR ITS SINGLE DOSE EQUIVALENT |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| EQ 400MG BASE/VIAL | ORBACTIV | MELINTA THERAP | N206334 | Aug. 6, 2014 | RX | POWDER | INTRAVENOUS | Aug. 6, 2019 | NEW CHEMICAL ENTITY |
| EQ 1.2GM BASE/VIAL | KIMYRSA | MELINTA THERAP | N214155 | March 12, 2021 | RX | POWDER | INTRAVENOUS | Aug. 6, 2019 | NEW CHEMICAL ENTITY |
| EQ 1.2GM BASE/VIAL | KIMYRSA | MELINTA THERAP | N214155 | March 12, 2021 | RX | POWDER | INTRAVENOUS | March 12, 2024 | NEW PRODUCT |
| EQ 400MG BASE/VIAL | ORBACTIV | MELINTA THERAP | N206334 | Aug. 6, 2014 | RX | POWDER | INTRAVENOUS | Aug. 6, 2024 | GENERATING ANTIBIOTIC INCENTIVES NOW |
| EQ 1.2GM BASE/VIAL | KIMYRSA | MELINTA THERAP | N214155 | March 12, 2021 | RX | POWDER | INTRAVENOUS | Aug. 6, 2024 | GENERATING ANTIBIOTIC INCENTIVES NOW |
Bioactivity Summary:
None
External reference:
| ID | Source |
|---|---|
| D05271 | KEGG_DRUG |
| 4033672 | VUID |
| N0000191086 | NUI |
| 192564-14-0 | SECONDARY_CAS_RN |
| 4033671 | VANDF |
| 4033672 | VANDF |
| CHEBI:83305 | CHEBI |
| CHEMBL1688530 | ChEMBL_ID |
| CHEMBL3989766 | ChEMBL_ID |
| C100708 | MESH_SUPPLEMENTAL_RECORD_UI |
| 10877 | IUPHAR_LIGAND_ID |
| 7979 | INN_ID |
| DB04911 | DRUGBANK_ID |
| PUG62FRZ2E | UNII |
| 16136912 | PUBCHEM_CID |
| 1547611 | RXNORM |
| 227540 | MMSL |
| 30470 | MMSL |
| 39633 | MMSL |
| d08276 | MMSL |
| 015538 | NDDF |
| 015661 | NDDF |
| 704655001 | SNOMEDCT_US |
| 704656000 | SNOMEDCT_US |
| C1144403 | UMLSCUI |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Orbactiv | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70842-140 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 400 mg | INTRAVENOUS | NDA | 32 sections |
| Orbactiv | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70842-140 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 400 mg | INTRAVENOUS | NDA | 32 sections |
| Kimyrsa | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70842-225 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 1200 mg | INTRAVENOUS | NDA | 31 sections |