Stem definition | Drug id | CAS RN |
---|---|---|
4678 | 171099-57-3 |
None
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 |
Date | Agency | Company | Orphan |
---|---|---|---|
March 19, 2015 | EMA | ||
Aug. 6, 2014 | FDA | THE MEDICINES CO |
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 |
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 |
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 |
None
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 |
Disease | Relation | SNOMED_ID | DOID |
---|---|---|---|
Bacterial infection of skin | indication | 128936008 | |
Streptococcal infection of skin | indication | 402937004 | |
Staphylococcal infection of skin | indication | 402938009 |
None
None
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 |
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 |
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 |
None
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 |
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 |