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Drug ReportsOmbitasvir
Viekira pak (copackaged), Viekirax(ombitasvir)
Technivie, Viekira, Viekirax (ombitasvir) is a small molecule pharmaceutical. Ombitasvir was first approved as Viekira pak (copackaged) on 2014-12-19. It is used to treat chronic hepatitis c and hepatitis c in the USA. It has been approved in Europe to treat chronic hepatitis c.
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Drug
Target
Variants
Financial
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Events Timeline
5D
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3M
6M
YTD
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2Y
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FDA approval date
EMA approval date
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Study first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
digestive system diseasesD004066
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ombitasvir
+
Paritaprevir
+
Ritonavir
Tradename
Company
Number
Date
Products
TECHNIVIEAbbVieN-207931 DISCN2015-07-24
1 products, RLD
Hide discontinued
Dasabuvir sodium
+
Ombitasvir
+
Paritaprevir
+
Ritonavir
Tradename
Company
Number
Date
Products
VIEKIRA PAK (COPACKAGED)AbbVieN-206619 DISCN2014-12-19
1 products, RLD
VIEKIRA XRAbbVieN-208624 DISCN2016-07-22
1 products, RLD
Hide discontinued
Labels
FDA
EMA
No data
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hepatitis c—D006526B19.2
acquired immunodeficiency syndromeEFO_0000765D000163B20
chronic hepatitis cEFO_0004220D019698B18.2
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Dasabuvir Sodium / Ombitasvir / Paritaprevir / Ritonavir, Viekira Xr, Abbvie
93332042035-01-02DPU-1889
97441702035-01-02DPU-1889
101053652035-01-02DPU-1889
102015412032-05-17DP
102015842032-05-17U-1889
Dasabuvir Sodium / Ombitasvir / Paritaprevir / Ritonavir, Viekira Pak (Copackaged), Abbvie
96298412033-10-18DPU-1753
102015422033-10-18DPU-1753
84661592032-09-04U-1637
84923862032-09-04U-1840
86801062032-09-04U-1637
86859842032-09-04U-1840
86919382032-04-13DS, DP
86860262031-06-09DP
84205962031-04-10DS, DP
90444802031-04-10U-1638
90063872030-06-10U-1687
86425382029-09-10DS, DPU-1638
81881042029-05-17DS, DPU-1636
85012382028-12-19DS, DPU-1636
91395362028-11-09U-1753
82683492024-08-25DP
83990152024-08-25DP
ATC Codes
J: Antiinfectives for systemic use
— J05: Antivirals for systemic use
— J05A: Direct acting antivirals
— J05AP: Antivirals for treatment of hcv infections
— J05AP52: Dasabuvir, ombitasvir, paritaprevir and ritonavir
— J05AP53: Ombitasvir, paritaprevir and ritonavir
HCPCS
No data
Clinical
Clinical Trials
104 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hepatitis cD006526—B19.2—92962162
HepatitisD006505—K75.9—92932159
Hepatitis aD006506EFO_0007305B15—92932159
Chronic hepatitis cD019698EFO_0004220B18.2—92661957
InfectionsD007239EFO_0000544——6181—23
Hiv infectionsD015658EFO_0000764B20—111—2
CoinfectionD060085———111—2
Hepatitis virusesD006518—————1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic hepatitisD006521—K73.9—924—1747
Communicable diseasesD003141———611——15
Chronic hepatitis bD019694EFO_0004239B18.1—58——12
HepacivirusD016174———28—110
FibrosisD005355———27—19
Liver cirrhosisD008103EFO_0001422K74.0—25—17
Virus diseasesD014777—B34—25——6
Kidney diseasesD007674EFO_0003086N08——3——3
Chronic kidney failureD007676EFO_0003884N18.6——2——2
Acquired immunodeficiency syndromeD000163EFO_0000765B20—11——1
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Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HomozygoteD006720——————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameOmbitasvir
INNombitasvir
Description
Ombitasvir is a dipeptide derivative which is used which is in combination with dasabuvir sodium hydrate, paritaprevir and ritonavir (under the trade name Viekira Pak) for treatment of chronic hepatitis C virus genotype 1 infection as well as cirrhosis of the liver. It has a role as an antiviral drug and a hepatitis C virus nonstructural protein 5A inhibitor. It is a member of pyrrolidines, a carbamate ester, an aromatic amide and a dipeptide. It is functionally related to a Val-Pro.
Classification
Small molecule
Drug classantivirals: nonstructural protein 5A (NS5A) inhibitors
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
COC(=O)N[C@H](C(=O)N1CCC[C@H]1C(=O)Nc1ccc([C@@H]2CC[C@@H](c3ccc(NC(=O)[C@@H]4CCCN4C(=O)[C@@H](NC(=O)OC)C(C)C)cc3)N2c2ccc(C(C)(C)C)cc2)cc1)C(C)C
Identifiers
PDB—
CAS-ID1258226-87-7
RxCUI—
ChEMBL IDCHEMBL3127326
ChEBI ID85183
PubChem CID54767916
DrugBank—
UNII ID2302768XJ8 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Viekira – AbbVie
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,439 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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15,827 adverse events reported
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