oritavancin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
vancomycin related compounds	4678	171099-57-3

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: oritavancin diphosphate orbactiv LY333328 oritavancin	Molecular weight: 1793.12 Formula: C86H97Cl3N10O26 CLOGP: 2.50 LIPINSKI: 3 HAC: 36 HDO: 20 TPSA: 560.98 ALOGS: -4.48 ROTB: 19

Molecule

Description

Molfile Inchi Smiles

Synonyms:

oritavancin diphosphate
orbactiv
LY333328
oritavancin

Molecular weight: 1793.12
Formula: C86H97Cl3N10O26
CLOGP: 2.50
LIPINSKI: 3
HAC: 36
HDO: 20
TPSA: 560.98
ALOGS: -4.48
ROTB: 19

Drug dosage:

None

ADMET properties:

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Property	Value	Reference
t_half (Half-life)	96.20 hours	Lombardo F, Berellini G, Obach RS
Vd (Volume of distribution)	0.30 L/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.13 %	Lombardo F, Berellini G, Obach RS
CL (Clearance)	0.07 mL/min/kg	Lombardo F, Berellini G, Obach RS

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Approvals:

Date	Agency	Company	Orphan
Aug. 6, 2014	FDA	THE MEDICINES CO
March 19, 2015	EMA

FDA Adverse Event Reporting System (Female)

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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	178.20	70.17	86	690	361367	63126879
Urticaria	97.76	70.17	45	731	165757	63322489
Off label use	86.12	70.17	68	708	674394	62813852
Multiple use of single-use product	72.53	70.17	13	763	1479	63486767

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FDA Adverse Event Reporting System (Male)

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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
Multiple use of single-use product	167.16	62.10	24	902	295	34955710
Chills	157.54	62.10	64	862	80979	34875026
Infusion related reaction	96.16	62.10	40	886	53017	34902988
Off label use	95.82	62.10	82	844	419442	34536563
Back pain	88.69	62.10	49	877	121740	34834265
Pruritus	66.38	62.10	43	883	141938	34814067

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FDA Adverse Event Reporting System (Geriatric)

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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
Multiple use of single-use product	187.95	61.13	29	1397	895	79742067
Chills	177.91	61.13	76	1350	160158	79582804
Pruritus	169.87	61.13	98	1328	394550	79348412
Off label use	146.54	61.13	123	1303	907092	78835870
Infusion related reaction	136.89	61.13	71	1355	230166	79512796
Urticaria	133.17	61.13	65	1361	185136	79557826
Back pain	90.54	61.13	60	1366	304120	79438842
Erythema	66.15	61.13	44	1382	223246	79519716
Chest pain	61.29	61.13	46	1380	282258	79460704

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	J01XA05	ANTIINFECTIVES FOR SYSTEMIC USE ANTIBACTERIALS FOR SYSTEMIC USE OTHER ANTIBACTERIALS Glycopeptide antibacterials
CHEBI has role	CHEBI:33281	antibiotics
CHEBI has role	CHEBI:36047	antibacterial drugs
FDA CS	M000640741	Lipoglycopeptides
FDA EPC	N0000191281	Lipoglycopeptide Antibacterial
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
MeSH PA	D000900	Anti-Bacterial Agents

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Drug Use | Suggest Off label Use Form| |View source of the data|

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Disease	Relation	SNOMED_ID
Bacterial infection of skin	indication	128936008
Streptococcal infection of skin	indication	402937004
Staphylococcal infection of skin	indication	402938009

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	2.05	acidic
pKa10	13.67	acidic
pKa11	9.27	Basic
pKa12	8.57	Basic
pKa13	8.3	Basic
pKa2	7.69	acidic
pKa3	10.72	acidic
pKa4	11.48	acidic
pKa5	11.49	acidic
pKa6	12.17	acidic

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Orange Book patent data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
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 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
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 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

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Orange Book exclusivity data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
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 1.2GM BASE/VIAL	KIMYRSA	MELINTA THERAP	N214155	March 12, 2021	RX	POWDER	INTRAVENOUS	Aug. 6, 2024	GENERATING ANTIBIOTIC INCENTIVES NOW
EQ 400MG BASE/VIAL	ORBACTIV	MELINTA THERAP	N206334	Aug. 6, 2014	RX	POWDER	INTRAVENOUS	Aug. 6, 2019	NEW CHEMICAL ENTITY
EQ 400MG BASE/VIAL	ORBACTIV	MELINTA THERAP	N206334	Aug. 6, 2014	RX	POWDER	INTRAVENOUS	Aug. 6, 2024	GENERATING ANTIBIOTIC INCENTIVES NOW

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Bioactivity Summary:

None

External reference:

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ID	Source
015538	NDDF
015661	NDDF
10877	IUPHAR_LIGAND_ID
1547611	RXNORM
16136912	PUBCHEM_CID
192564-14-0	SECONDARY_CAS_RN
227540	MMSL
30470	MMSL
39633	MMSL
4033671	VANDF

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Kimyrsa	HUMAN PRESCRIPTION DRUG LABEL	1	70842-225	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	1200 mg	INTRAVENOUS	NDA	31 sections
Kimyrsa	HUMAN PRESCRIPTION DRUG LABEL	1	70842-225	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	1200 mg	INTRAVENOUS	NDA	31 sections
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
Orbactiv	HUMAN PRESCRIPTION DRUG LABEL	1	70842-140	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	400 mg	INTRAVENOUS	NDA	32 sections

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