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Viekira pak (copackaged), Exviera(dasabuvir)
Exviera, Viekira (dasabuvir) is a small molecule pharmaceutical. Dasabuvir 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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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)
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
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Labels
FDA
EMA
No data
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
chronic hepatitis cEFO_0004220D019698B18.2
hepatitis c—D006526B19.2
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
— J05AP09: Dasabuvir
— J05AP52: Dasabuvir, ombitasvir, paritaprevir and ritonavir
HCPCS
No data
Clinical
Clinical Trials
64 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic hepatitis cD019698EFO_0004220B18.2—5105625
Hepatitis cD006526B19.24651—16
HepacivirusD016174—241—7
Hiv infectionsD015658EFO_0000764B20—211—3
Chronic renal insufficiencyD051436N18———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic hepatitis bD019694EFO_0004197B18.1—913—121
Liver cirrhosisD008103EFO_0001422K74.0—25—17
Hepatitis bD006509—11——1
HepatitisD006505HP_0012115K75.9—11——1
FibrosisD005355——1——1
Chronic kidney failureD007676EFO_0003884N18.6——1——1
Renal insufficiencyD051437HP_0000083N19——1——1
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
Papillomavirus infectionsD0303611————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDASABUVIR
INNdasabuvir
Description
Dasabuvir is a member of the class of pyrimidone, which is (as the monohydrate of its sodium salt) in combination with ombitasvir, 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 nonnucleoside hepatitis C virus polymerase inhibitor. It is a member of naphthalenes, a sulfonamide, an aromatic ether and a pyrimidone. It is functionally related to a uracil.
Classification
Small molecule
Drug classantivirals: RNA polymerase (NS5B) inhibitors
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
COc1c(-c2ccc3cc(NS(C)(=O)=O)ccc3c2)cc(-n2ccc(=O)[nH]c2=O)cc1C(C)(C)C
Identifiers
PDB—
CAS-ID1132935-63-7
RxCUI1597381
ChEMBL IDCHEMBL3137312
ChEBI ID85182
PubChem CID56640146
DrugBankDB09183
UNII IDDE54EQW8T1 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Viekira - AbbVie
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,026 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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4 adverse events reported
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