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Orbactiv, Tenkasi (previously orbactiv)(oritavancin)
Kimyrsa, Orbactiv, Tenkasi (oritavancin) is an unknown pharmaceutical. Oritavancin was first approved as Orbactiv on 2014-08-06. It is used to treat bacterial infections, infectious skin diseases, staphylococcal infections, and streptococcal infections in the USA. It has been approved in Europe to treat bacterial skin diseases and soft tissue infections.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
skin and connective tissue diseasesD017437
Trade Name
FDA
EMA
Kimyrsa, Orbactiv
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Oritavancin diphosphate
Tradename
Company
Number
Date
Products
ORBACTIVMelinta TherapeuticsN-206334 RX2014-08-06
1 products, RLD, RS
KIMYRSAMelinta TherapeuticsN-214155 RX2021-03-12
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
kimyrsaNew Drug Application2021-03-19
orbactivNew Drug Application2020-11-23
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
bacterial infections—D001424A49
infectious skin diseases—D012874—
staphylococcal infections—D013203A49.01
streptococcal infectionsEFO_1001476D013290—
Agency Specific
FDA
EMA
Expiration
Code
ORITAVANCIN DIPHOSPHATE, KIMYRSA, MELINTA THERAP
2024-08-06GAIN
2024-03-12NP
2019-08-06NCE
ORITAVANCIN DIPHOSPHATE, ORBACTIV, MELINTA THERAP
2024-08-06GAIN
2019-08-06NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Oritavancin Diphosphate, Kimyrsa, Melinta Therap
96493522035-07-16DP
96820612030-04-26U-1569, U-3101
84205922029-08-29U-1570, U-3101
ATC Codes
J: Antiinfectives for systemic use
— J01: Antibacterials for systemic use
— J01X: Other antibacterials in atc
— J01XA: Glycopeptide antibacterials
— J01XA05: Oritavancin
HCPCS
Code
Description
J2406
Injection, oritavancin (kimyrsa), 10 mg
J2407
Injection, oritavancin (orbactiv), 10 mg
Clinical
Clinical Trials
17 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
BacteremiaD016470EFO_0003033R78.81———2—2
EndocarditisD004696EFO_0000465I33———1—1
Bacterial skin diseasesD017192———1—1
Substance-related disordersD019966EFO_0003890F13———1—1
OsteomyelitisD010019EFO_0003102M86———1—1
Soft tissue infectionsD018461———1—1
Infectious arthritisD001170EFO_1001351M00———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AbscessD000038EFO_0003030—12——3
CellulitisD002481EFO_0003035L03.90—12——3
InflammationD007249——2——2
Wound infectionD014946——2——2
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Wounds and injuriesD014947T14.8—1———1
Staphylococcal skin infectionsD013207EFO_1001849L00—1———1
Streptococcal infectionsD013290EFO_1001476—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—6————6
Gram-positive bacterial infectionsD0169081———12
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameORITAVANCIN
INNoritavancin
Description
Oritavancin is a semisynthetic glycopeptide used (as its bisphosphate salt) for the treatment of acute bacterial skin and skin structure infections caused or suspected to be caused by susceptible isolates of designated Gram-positive microorganisms including MRSA. It has a role as an antibacterial drug and an antimicrobial agent. It is a disaccharide derivative, a glycopeptide and a semisynthetic derivative. It is functionally related to a vancomycin aglycone.
Classification
Small molecule
Drug classvancomycin-related compounds
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CN[C@H](CC(C)C)C(=O)N[C@H]1C(=O)N[C@@H](CC(N)=O)C(=O)N[C@H]2C(=O)N[C@H]3C(=O)N[C@H](C(=O)N[C@H](C(=O)O)c4cc(O)cc(O)c4-c4cc3ccc4O)[C@H](O[C@H]3C[C@](C)(N)[C@@H](O)[C@H](C)O3)c3ccc(c(Cl)c3)Oc3cc2cc(c3O[C@@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O[C@H]2C[C@](C)(NCc3ccc(-c4ccc(Cl)cc4)cc3)[C@@H](O)[C@H](C)O2)Oc2ccc(cc2Cl)[C@H]1O
Identifiers
PDB—
CAS-ID171099-57-3
RxCUI1547611
ChEMBL IDCHEMBL1688530
ChEBI ID82699
PubChem CID16136912
DrugBankDB04911
UNII IDPUG62FRZ2E (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Orbactiv - The Medicines Company
$
€
£
₣
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Orbactiv - MELINTA THERAPEUTICS, INC. /NEW/
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,306 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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15,726 adverse events reported
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