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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Commercial
Trade Name
FDA
EMA
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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
Ombitasvir
+
Paritaprevir
+
Ritonavir
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TECHNIVIE | AbbVie | N-207931 DISCN | 2015-07-24 | 1 products, RLD |
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Labels
FDA
EMA
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Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| chronic hepatitis c | EFO_0004220 | D019698 | B18.2 |
| hepatitis c | — | D006526 | B19.2 |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Dasabuvir Sodium / Ombitasvir / Paritaprevir / Ritonavir, Viekira Xr, Abbvie | |||
| 9333204 | 2035-01-02 | DP | U-1889 |
| 9744170 | 2035-01-02 | DP | U-1889 |
| 10105365 | 2035-01-02 | DP | U-1889 |
| 10201541 | 2032-05-17 | DP | |
| 10201584 | 2032-05-17 | U-1889 | |
| Dasabuvir Sodium / Ombitasvir / Paritaprevir / Ritonavir, Viekira Pak (Copackaged), Abbvie | |||
| 9629841 | 2033-10-18 | DP | U-1753 |
| 10201542 | 2033-10-18 | DP | U-1753 |
| 8466159 | 2032-09-04 | U-1637 | |
| 8492386 | 2032-09-04 | U-1840 | |
| 8680106 | 2032-09-04 | U-1637 | |
| 8685984 | 2032-09-04 | U-1840 | |
| 8691938 | 2032-04-13 | DS, DP | |
| 8686026 | 2031-06-09 | DP | |
| 8420596 | 2031-04-10 | DS, DP | |
| 9044480 | 2031-04-10 | U-1638 | |
| 9006387 | 2030-06-10 | U-1687 | |
| 8642538 | 2029-09-10 | DS, DP | U-1638 |
| 8188104 | 2029-05-17 | DS, DP | U-1636 |
| 8501238 | 2028-12-19 | DS, DP | U-1636 |
| 9139536 | 2028-11-09 | U-1753 | |
| 8268349 | 2024-08-25 | DP | |
| 8399015 | 2024-08-25 | DP | |
HCPCS
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Clinical
Clinical Trials
70 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 c | D019698 | EFO_0004220 | B18.2 | — | 9 | 11 | 5 | 6 | 30 |
| Hepatitis c | D006526 | B19.2 | 2 | 4 | 5 | 1 | 1 | 13 | |
| Hepacivirus | D016174 | — | 2 | 6 | 1 | — | 9 | ||
| Hiv infections | D015658 | EFO_0000764 | B20 | — | 2 | 1 | 1 | 1 | 4 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | — | 1 | 1 | — | 2 |
| Chronic renal insufficiency | D051436 | N18 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic hepatitis b | D019694 | EFO_0004197 | B18.1 | — | 7 | 14 | — | 1 | 20 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | 2 | 5 | — | 1 | 7 |
| Hepatitis b | D006509 | — | 1 | 1 | — | — | 1 | ||
| Hepatitis | D006505 | HP_0012115 | K75.9 | — | 1 | 1 | — | — | 1 |
| Fibrosis | D005355 | — | — | 1 | — | — | 1 | ||
| Renal insufficiency | D051437 | HP_0000083 | N19 | — | — | 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 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Retinal diseases | D012164 | HP_0000479 | H35.9 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | OMBITASVIR |
| INN | ombitasvir |
| 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 class | antivirals: nonstructural protein 5A (NS5A) inhibitors |
| Image (chem structure or protein) | |
| 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-ID | 1258226-87-7 |
| RxCUI | 1597371 |
| ChEMBL ID | CHEMBL3127326 |
| ChEBI ID | 85183 |
| PubChem CID | 54767916 |
| DrugBank | DB09296 |
| UNII ID | 2302768XJ8 (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
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Variants
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Financial
Viekira - AbbVie
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Safety
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Adverse Events
Top Adverse Reactions
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61,764 adverse events reported
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