Norvir(ritonavir)
Kaletra, Norvir, Paxlovid, Ritonavir, Technivie, Viekira, Viekirax (ritonavir) is a small molecule pharmaceutical. Ritonavir was first approved as Norvir on 1996-03-01. It is used to treat acquired immunodeficiency syndrome in the USA. It has been approved in Europe to treat chronic hepatitis c and HIV infections. It is known to target UDP-glucuronosyltransferase 1A1, cytochrome P450 3A5, and cytochrome P450 3A4.
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Commercial
Trade Name
FDA
EMA
Norvir (generic drugs available since 2015-01-15)
CombinationsKaletra (generic drugs available since 2015-01-15, discontinued: Technivie, Viekira)
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
Lopinavir
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Ritonavir
Ombitasvir
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Paritaprevir
+
Ritonavir
Labels
FDA
EMA
No data
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| acquired immunodeficiency syndrome | EFO_0000765 | D000163 | B20 |
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 | |
ATC Codes
J: Antiinfectives for systemic use
— J05: Antivirals for systemic use
— J05A: Direct acting antivirals
— J05AE: Protease inhibitors, direct acting antivirals
— J05AE03: Ritonavir
— J05AP: Antivirals for treatment of hcv infections
— J05AP52: Dasabuvir, ombitasvir, paritaprevir and ritonavir
— J05AP53: Ombitasvir, paritaprevir and ritonavir
— J05AR: Antivirals for treatment of hiv infections, combinations
— J05AR10: Lopinavir and ritonavir
— J05AR23: Atazanavir and ritonavir
— J05AR26: Darunavir and ritonavir
HCPCS
No data
Clinical
Clinical Trials
1173 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv infections | D015658 | EFO_0000764 | B20 | 79 | 132 | 131 | 113 | 90 | 515 |
| Hiv | D006678 | — | O98.7 | 22 | 16 | 26 | 42 | 20 | 121 |
| Healthy volunteers/patients | — | — | — | 93 | 2 | — | 7 | 4 | 106 |
| Covid-19 | D000086382 | — | U07.1 | 9 | 42 | 36 | 10 | 26 | 105 |
| Chronic hepatitis c | D019698 | EFO_0004220 | B18.2 | 4 | 23 | 14 | 8 | 21 | 69 |
| Hepatitis c | D006526 | — | B19.2 | 14 | 11 | 12 | 4 | 5 | 43 |
| Infections | D007239 | EFO_0000544 | — | 12 | 9 | 11 | 2 | 1 | 35 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | 3 | 3 | 9 | 9 | 4 | 26 |
| Hiv-1 | D015497 | — | — | 1 | 9 | 5 | 6 | 1 | 22 |
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | 4 | 7 | — | 4 | 3 | 17 |
Show 38 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic hepatitis b | D019694 | EFO_0004239 | B18.1 | 4 | 13 | 14 | — | 2 | 30 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | 3 | 5 | — | 1 | 8 |
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | 1 | 2 | 1 | — | 3 | 6 |
| Severe acute respiratory syndrome | D045169 | EFO_0000694 | J12.81 | — | — | 1 | — | 2 | 3 |
| Chronic hepatitis d | D019701 | — | — | — | 2 | 1 | — | — | 3 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | 1 | — | — | 2 |
| Virus diseases | D014777 | — | B34 | — | — | 1 | — | 1 | 2 |
| Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | — | — | 1 | — | — | 1 |
| Cerebral hemorrhage | D002543 | — | — | — | — | 1 | — | — | 1 |
| Hepatitis | D006505 | HP_0012115 | K75.9 | — | 1 | 1 | — | — | 1 |
Show 7 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Viral pneumonia | D011024 | EFO_0007541 | J12.9 | — | 1 | — | — | 3 | 4 |
| Coronavirus | D017934 | — | — | — | 1 | — | — | 2 | 3 |
| Prostatic neoplasms | D011471 | — | C61 | 2 | 1 | — | — | — | 3 |
| Neoplasms | D009369 | — | C80 | 2 | 1 | — | — | — | 3 |
| Glioblastoma | D005909 | EFO_0000515 | — | 1 | 2 | — | — | — | 2 |
| Castration-resistant prostatic neoplasms | D064129 | — | — | 1 | 1 | — | — | — | 2 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 1 | — | — | — | 2 |
| Chronic hepatitis | D006521 | — | K73.9 | — | 2 | — | — | — | 2 |
| Hepatitis d | D003699 | EFO_0007304 | — | — | 2 | — | — | — | 2 |
| Disease | D004194 | EFO_0000408 | R69 | — | 1 | — | — | — | 1 |
Show 14 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pharmacokinetics | D010599 | — | — | 3 | — | — | — | 1 | 4 |
| Hepatic insufficiency | D048550 | — | — | 4 | — | — | — | — | 4 |
| Biological availability | D001682 | — | — | 4 | — | — | — | — | 4 |
| Pulmonary arterial hypertension | D000081029 | — | — | 2 | — | — | — | 1 | 3 |
| Hypertension | D006973 | EFO_0000537 | I10 | 1 | — | — | — | 1 | 2 |
| Asthma | D001249 | EFO_0000270 | J45 | 1 | — | — | — | 1 | 2 |
| Insulin resistance | D007333 | HP_0000855 | E88.819 | 1 | — | — | — | 1 | 2 |
| Therapeutic equivalency | D013810 | — | — | 1 | — | — | — | 1 | 2 |
| Toxoplasmosis | D014123 | EFO_0007517 | B58 | 1 | — | — | — | — | 1 |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | 1 | — | — | — | — | 1 |
Show 19 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Female genital diseases | D005831 | EFO_0009549 | N85 | — | — | — | — | 1 | 1 |
| Wasting syndrome | D019282 | — | — | — | — | — | — | 1 | 1 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | — | — | 1 | 1 |
| Heart failure | D006333 | HP_0001635 | I50 | — | — | — | — | 1 | 1 |
| Menorrhagia | D008595 | EFO_0003945 | N92.0 | — | — | — | — | 1 | 1 |
| Hemophilia a | D006467 | EFO_0007267 | D66 | — | — | — | — | 1 | 1 |
| Pain | D010146 | EFO_0003843 | R52 | — | — | — | — | 1 | 1 |
| Down syndrome | D004314 | EFO_0001064 | Q90 | — | — | — | — | 1 | 1 |
| Mucocutaneous lymph node syndrome | D009080 | EFO_0004246 | M30.3 | — | — | — | — | 1 | 1 |
| Hyperaldosteronism | D006929 | HP_0011736 | E26 | — | — | — | — | 1 | 1 |
Show 29 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Ritonavir |
| INN | ritonavir |
| Description | Ritonavir is an L-valine derivative that is L-valinamide in which alpha-amino group has been acylated by a [(2-isopropyl-1,3-thiazol-4-yl)methyl]methylcarbamoyl group and in which a hydrogen of the carboxamide amino group has been replaced by a (2R,4S,5S)-4-hydroxy-1,6-diphenyl-5-{[(1,3-thiazol-5-ylmethoxy)carbonyl]amino}hexan-2-yl group. A CYP3A inhibitor and antiretroviral drug from the protease inhibitor class used to treat HIV infection and AIDS, it is often used as a fixed-dose combination with another protease inhibitor, lopinavir. Also used in combination with dasabuvir sodium hydrate, ombitasvir and paritaprevir (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, a HIV protease inhibitor, an environmental contaminant and a xenobiotic. It is a member of 1,3-thiazoles, a L-valine derivative, a carbamate ester, a member of ureas and a carboxamide. |
| Classification | Small molecule |
| Drug class | antivirals: HIV protease inhibitors (saquinavir type) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC(C)c1nc(CN(C)C(=O)N[C@H](C(=O)N[C@@H](Cc2ccccc2)C[C@H](O)[C@H](Cc2ccccc2)NC(=O)OCc2cncs2)C(C)C)cs1 |
Identifiers
| PDB | — |
| CAS-ID | 155213-67-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL163 |
| ChEBI ID | 45409 |
| PubChem CID | 392622 |
| DrugBank | DB00503 |
| UNII ID | O3J8G9O825 (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
CYP3A4
CYP3A4
Organism
Homo sapiens
Gene name
CYP3A4
Gene synonyms
CYP3A3
NCBI Gene ID
Protein name
cytochrome P450 3A4
Protein synonyms
1,4-cineole 2-exo-monooxygenase, 1,8-cineole 2-exo-monooxygenase, Albendazole monooxygenase (sulfoxide-forming), Albendazole sulfoxidase, Cholesterol 25-hydroxylase, CYPIIIA3, CYPIIIA4, Cytochrome P450 3A3, Cytochrome P450 HLp, Cytochrome P450 NF-25, cytochrome P450, family 3, subfamily A, polypeptide 4, cytochrome P450, subfamily IIIA (niphedipine oxidase), polypeptide 3, cytochrome P450, subfamily IIIA (niphedipine oxidase), polypeptide 4, Cytochrome P450-PCN1, glucocorticoid-inducible P450, Nifedipine oxidase, P450-III, steroid inducible, Quinine 3-monooxygenase, taurochenodeoxycholate 6-alpha-hydroxylase
Uniprot ID
Mouse ortholog
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Variants
No data
Financial
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Norvir – AbbVie
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Viekira – AbbVie
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Paxlovid – Pfizer
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Kaletra – AbbVie
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Estimated US medical usage
Ritonavir
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Lopinavir
Total medical expenditures per year (USD, in millions)
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Ritonavir
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Trends
PubMed Central
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Safety
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Adverse Events
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56,477 adverse events reported
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