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, Ritonavir (discontinued: Norvir, Ritonavir)
CombinationsKaletra, Lopinavir ritonavir, Paxlovid (discontinued: Kaletra, Technivie, Viekira)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Lopinavir
+
Ritonavir
Ritonavir
Ombitasvir
+
Paritaprevir
+
Ritonavir
Dasabuvir sodium
+
Ombitasvir
+
Paritaprevir
+
Ritonavir
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| kaletra | New Drug Application | 2023-07-06 |
| lopinavir and ritonavir | ANDA | 2023-10-20 |
| lopinavir-ritonavir | ANDA | 2020-11-18 |
| norvir | New Drug Application | 2024-07-03 |
| paxlovid | New Drug Application | 2025-07-09 |
| ritonavir | ANDA | 2025-09-24 |
Indications
FDA
EMA
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
1193 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 | 1 | 2 | 3 | 4 | 1 | 11 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | 2 | — | 3 | 3 | — | 8 |
| Hiv | D006678 | — | O98.7 | — | — | — | 2 | — | 2 |
| Renal insufficiency | D051437 | — | N19 | 1 | — | — | 1 | — | 2 |
| Cognitive dysfunction | D060825 | — | G31.84 | — | — | — | 1 | — | 1 |
| Hepatitis c | D006526 | — | B19.2 | — | — | — | 1 | — | 1 |
| Hepatitis b | D006509 | — | — | — | — | — | 1 | — | 1 |
| Chronic hepatitis c | D019698 | EFO_0004220 | B18.2 | — | — | — | 1 | — | 1 |
| Hepatitis | D006505 | — | K75.9 | — | — | — | 1 | — | 1 |
| Hepatitis a | D006506 | EFO_0007305 | B15 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Covid-19 | D000086382 | — | U07.1 | 6 | 9 | 4 | — | 9 | 25 |
| Hiv-1 | D015497 | — | — | — | 3 | 1 | — | — | 4 |
| Infections | D007239 | EFO_0000544 | — | — | 2 | 1 | — | — | 3 |
| Inflammation | D007249 | MP_0001845 | — | — | 1 | 1 | — | — | 2 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | 1 | — | — | 1 |
| Communicable diseases | D003141 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Post-acute covid-19 syndrome | D000094024 | — | — | — | 3 | — | — | — | 3 |
| Pneumonia | D011014 | EFO_0003106 | J18 | — | 2 | — | — | — | 2 |
| Coronavirus infections | D018352 | EFO_0007224 | B34.2 | — | 1 | — | — | 1 | 2 |
| Sarcoma | D012509 | — | — | — | 1 | — | — | — | 1 |
| Kaposi sarcoma | D012514 | — | C46 | — | 1 | — | — | — | 1 |
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | — | 1 | — | — | — | 1 |
| Respiratory tract infections | D012141 | — | J06.9 | — | 1 | — | — | — | 1 |
| Respiratory tract diseases | D012140 | — | — | — | 1 | — | — | — | 1 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | — | 1 | — | — | — | 1 |
| Viral pneumonia | D011024 | EFO_0007541 | J12.9 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 11 | — | — | — | — | 11 |
| Biological availability | D001682 | — | — | 5 | — | — | — | — | 5 |
| Pulmonary arterial hypertension | D000081029 | — | — | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
| Severe acute respiratory syndrome | D045169 | EFO_0000694 | J12.81 | 1 | — | — | — | — | 1 |
| Breast feeding | D001942 | — | — | 1 | — | — | — | — | 1 |
| Pharmacokinetics | D010599 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
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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Paxlovid – Pfizer
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Kaletra – AbbVie
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Norvir – AbbVie
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Viekira – AbbVie
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Estimated US medical usage
Ritonavir
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Lopinavir
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Ritonavir
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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Norvir, Paxlovid, Ritonavir
Adverse Events
Top Adverse Reactions
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106,920 adverse events reported
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