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Drug ReportsOritavancin
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
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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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
KIMYRSAMelinta TherapeuticsN-214155 RX2021-03-12
1 products, RLD, RS
ORBACTIVMelinta TherapeuticsN-206334 RX2014-08-06
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
kimyrsaNew Drug Application2021-07-30
orbactivNew Drug Application2022-02-25
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
19 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InfectionsD007239EFO_0000544122319
Communicable diseasesD003141112318
Bacterial skin diseasesD0171921124
BacteremiaD016470EFO_0003033R78.8122
Soft tissue infectionsD01846122
Staphylococcal infectionsD013203A49.0111
EndocarditisD004696HP_010058411
Skin diseasesD012871L00-L9911
Opioid-related disordersD009293EFO_0005611F1111
Substance-related disordersD019966EFO_0003890F1311
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AbscessD000038EFO_0003030123
CellulitisD002481EFO_0003035L03.90123
InflammationD007249MP_000184522
Wound infectionD01494622
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Wounds and injuriesD014947T14.811
Staphylococcal skin infectionsD013207EFO_1001849L0011
Infectious skin diseasesD01287411
Streptococcal infectionsD013290EFO_100147611
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients66
Bacterial infectionsD001424A49112
Gram-positive bacterial infectionsD016908112
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Diabetic footD017719EFO_100145911
Foot ulcerD01652311
OsteitisD01000011
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameOritavancin
INNoritavancin
Description
Oritavancin, sold under the brand name Orbactiv among others, is a semisynthetic glycopeptide antibiotic medication for the treatment of serious Gram-positive bacterial infections. Its chemical structure as a lipoglycopeptide is similar to vancomycin.
Classification
Small molecule
Drug classvancomycin-related compounds
Image (chem structure or protein)Loading
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
RxCUI
ChEMBL IDCHEMBL1688530
ChEBI ID82699
PubChem CID16131319
DrugBankDB04911
UNII IDPUG62FRZ2E (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
£
Orbactiv The Medicines Company
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Orbactiv Melinta Therapeutics /new/
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,573 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,045 adverse events reported
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