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ritonavir 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
HIV protease inhibitors	2391	155213-67-5

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: ABT538 ABT-538 ritonavir norvir	Ritonavir is a peptidomimetic inhibitor of the HIV-1 protease. Inhibition of HIV protease renders the enzyme incapable of processing the Gag-Pol polyprotein precursor which leads to production of non-infectious immature HIV particles. Nirmatrelvir plus ritonavir (Paxlovid) has been approved for the treatment and post-exposure prophylaxis of coronavirus disease 2019 (COVID-19). Molecular weight: 720.95 Formula: C37H48N6O5S2 CLOGP: 5.09 LIPINSKI: 2 HAC: 11 HDO: 4 TPSA: 145.78 ALOGS: -5.76 ROTB: 18 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

ABT538
ABT-538
ritonavir
norvir

Ritonavir is a peptidomimetic inhibitor of the HIV-1 protease. Inhibition of HIV protease renders the enzyme incapable of processing the Gag-Pol polyprotein precursor which leads to production of non-infectious immature HIV particles. Nirmatrelvir plus ritonavir (Paxlovid) has been approved for the treatment and post-exposure prophylaxis of coronavirus disease 2019 (COVID-19).

Molecular weight: 720.95
Formula: C37H48N6O5S2
CLOGP: 5.09
LIPINSKI: 2
HAC: 11
HDO: 4
TPSA: 145.78
ALOGS: -5.76
ROTB: 18

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
1.20	g	O
0.60	g	O
0.80	g	O
0.30	g	O

ADMET properties:

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Property	Value	Reference
BA (Bioavailability)	70 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
EoM (Fraction excreted unchanged in urine)	3.50 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	23.78 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI

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Approvals:

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Date	Agency	Company
Aug. 25, 1996	EMA	AbbVie Deutschland GmbH Co. KG
Feb. 10, 2022	PMDA	PFIZER JAPAN INC
March 1, 1996	FDA	ABBVIE

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FDA Adverse Event Reporting System (Female)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Abortion spontaneous	2110.24	18.23	767	24433	46428	63417394
Exposure during pregnancy	2081.78	18.23	1076	24124	154471	63309351
Foetal exposure during pregnancy	1897.86	18.23	642	24558	31320	63432502
Maternal exposure during pregnancy	922	18.23	733	24467	219329	63244493
Premature baby	752.82	18.23	290	24910	20445	63443377
Abortion induced	731.69	18.23	237	24963	10005	63453817
Stillbirth	713.84	18.23	211	24989	6539	63457283
Drug interaction	616.73	18.23	594	24606	228537	63235285
Live birth	529.84	18.23	240	24960	25390	63438432
Caesarean section	434.61	18.23	185	25015	16847	63446975

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FDA Adverse Event Reporting System (Male)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Foetal exposure during pregnancy	1093.37	12.14	654	44334	37447	34874496
Immune reconstitution inflammatory syndrome	749.66	12.14	316	44672	8443	34903500
Drug interaction	740.06	12.14	1157	43831	224789	34687154
Lipodystrophy acquired	666.13	12.14	224	44764	3120	34908823
Virologic failure	381.41	12.14	150	44838	3330	34908613
Renal tubular disorder	365.68	12.14	158	44830	4485	34907458
Mitochondrial toxicity	319.38	12.14	123	44865	2576	34909367
Premature baby	319.31	12.14	237	44751	19396	34892547
Fanconi syndrome acquired	310.01	12.14	111	44877	1880	34910063
Exposure during pregnancy	305.11	12.14	172	44816	8762	34903181

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FDA Adverse Event Reporting System (Geriatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Abortion spontaneous	1770.98	13.40	676	49960	28831	79664921
Drug interaction	1512.03	13.40	1570	49066	413613	79280139
Exposure during pregnancy	1154.84	13.40	747	49889	100385	79593367
Immune reconstitution inflammatory syndrome	934.76	13.40	346	50290	13495	79680257
Lipodystrophy acquired	890.19	13.40	252	50384	4073	79689679
Maternal exposure during pregnancy	628.72	13.40	589	50047	135949	79557803
Virologic failure	628.25	13.40	191	50445	4000	79689752
Abortion induced	578.34	13.40	204	50432	6905	79686847
Stillbirth	540.91	13.40	168	50468	3787	79689965
Renal tubular disorder	429.91	13.40	160	50476	6326	79687426

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FDA Adverse Event Reporting System (Pediatric)

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Pharmacologic Action:

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Source	Code	Description
ATC	J05AE03	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Protease inhibitors
ATC	J05AE30	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Protease inhibitors
ATC	J05AP52	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HCV infections
ATC	J05AP53	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HCV infections
ATC	J05AR10	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations
ATC	J05AR23	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations
ATC	J05AR26	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations
CHEBI has role	CHEBI:35660	HIV protease inhibitors
CHEBI has role	CHEBI:35703	Xenobiotic
CHEBI has role	CHEBI:36044	antiviral drugs

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Drug Use | Suggest Off label Use Form| |View source of the data|

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Disease	Relation	SNOMED_ID	DOID
Human immunodeficiency virus infection	indication	86406008	DOID:526
Chronic hepatitis C	indication	128302006
COVID-19	indication	840539006
Prevention of HIV Infection after Exposure	off-label use
Hypercholesterolemia	contraindication	13644009
Hyperbilirubinemia	contraindication	14783006	DOID:2741
Cirrhosis of liver	contraindication	19943007	DOID:5082
Complete atrioventricular block	contraindication	27885002
Hereditary factor VIII deficiency disease	contraindication	28293008	DOID:12134
Torsades de pointes	contraindication	31722008

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

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Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	12.39	acidic
pKa2	13.84	acidic
pKa3	3.62	Basic
pKa4	2.45	Basic

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Orange Book patent data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
12.5MG;75MG;50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TECHNIVIE	ABBVIE	N207931	July 24, 2015	DISCN	TABLET	ORAL	8642538	Sept. 10, 2029	TREATMENT OF HCV INFECTION USING PARITAPREVIR
12.5MG;75MG;50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TECHNIVIE	ABBVIE	N207931	July 24, 2015	DISCN	TABLET	ORAL	9006387	June 10, 2030	TREATMENT OF HCV INFECTION USING OMBITASVIR
12.5MG;75MG;50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TECHNIVIE	ABBVIE	N207931	July 24, 2015	DISCN	TABLET	ORAL	9044480	April 10, 2031	TREATMENT OF HCV INFECTION USING PARITAPREVIR
150MG;100MG	PAXLOVID (COPACKAGED)	PFIZER	N217188	May 25, 2023	RX	TABLET	ORAL	11351149	Aug. 5, 2041	TREATMENT OF MILD-TO-MODERATE CORONAVIRUS DISEASE 2019 (COVID-19) IN ADULTS WHO ARE AT HIGH RISK FOR PROGRESSION TO SEVERE COVID-19, INCLUDING HOSPITALIZATION OR DEATH
150MG;100MG	PAXLOVID (COPACKAGED)	PFIZER	N217188	May 25, 2023	RX	TABLET	ORAL	11541034	Oct. 31, 2041	TREATMENT OF MILD-TO-MODERATE CORONAVIRUS DISEASE 2019 (COVID-19) IN ADULTS WHO ARE AT HIGH RISK FOR PROGRESSION TO SEVERE COVID-19, INCLUDING HOSPITALIZATION OR DEATH
EQ 200MG BASE;8.33MG;50MG;33.33MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	VIEKIRA XR	ABBVIE	N208624	July 22, 2016	DISCN	TABLET, EXTENDED RELEASE	ORAL	8501238	Sept. 17, 2028	USE OF DASABUVIR TO INHIBIT VIRAL REPLICATION FOR THE TREATMENT OF HCV INFECTION.
EQ 200MG BASE;8.33MG;50MG;33.33MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	VIEKIRA XR	ABBVIE	N208624	July 22, 2016	DISCN	TABLET, EXTENDED RELEASE	ORAL	9139536	Nov. 9, 2028	TREATMENT OF HCV INFECTION USING DASABUVIR
EQ 200MG BASE;8.33MG;50MG;33.33MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	VIEKIRA XR	ABBVIE	N208624	July 22, 2016	DISCN	TABLET, EXTENDED RELEASE	ORAL	8188104	May 17, 2029	USE OF DASABUVIR TO INHIBIT VIRAL REPLICATION FOR THE TREATMENT OF HCV INFECTION.
EQ 200MG BASE;8.33MG;50MG;33.33MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	VIEKIRA XR	ABBVIE	N208624	July 22, 2016	DISCN	TABLET, EXTENDED RELEASE	ORAL	8642538	Sept. 10, 2029	TREATMENT OF HCV INFECTION USING PARITAPREVIR
EQ 200MG BASE;8.33MG;50MG;33.33MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	VIEKIRA XR	ABBVIE	N208624	July 22, 2016	DISCN	TABLET, EXTENDED RELEASE	ORAL	9006387	June 10, 2030	TREATMENT OF HCV INFECTION USING OMBITASVIR

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Orange Book exclusivity data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
150MG;100MG	PAXLOVID (COPACKAGED)	PFIZER	N217188	May 25, 2023	RX	TABLET	ORAL	May 25, 2028	NEW CHEMICAL ENTITY
300MG;100MG	PAXLOVID (COPACKAGED)	PFIZER	N217188	May 25, 2023	RX	TABLET	ORAL	May 25, 2028	NEW CHEMICAL ENTITY

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Bioactivity Summary:

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Target	Class	Pharos	UniProt	Type	Activity value (-log[M])	Bioact source
Cytochrome P450 3A4	Enzyme	P08684	CP3A4_HUMAN	IC50	7.55	WOMBAT-PK
Multidrug resistance protein 1	Transporter	P08183	MDR1_HUMAN	IC50	5.83	WOMBAT-PK
Cytochrome P450 2D6	Enzyme	P10635	CP2D6_HUMAN	IC50	4.30	DRUG MATRIX
Nuclear receptor subfamily 1 group I member 2	Nuclear hormone receptor	O75469	NR1I2_HUMAN			WOMBAT-PK
Kappa-type opioid receptor	GPCR	P41145	OPRK_HUMAN	Ki	5.26	DRUG MATRIX
Cytochrome P450 2C9	Enzyme	P11712	CP2C9_HUMAN	IC50	7.80	DRUG MATRIX
Vasopressin V1a receptor	GPCR	P37288	V1AR_HUMAN	Ki	5.30	DRUG MATRIX
Thromboxane-A synthase	Enzyme	P24557	THAS_HUMAN	IC50	7.12	DRUG MATRIX
Solute carrier family 22 member 1	Transporter	O15245	S22A1_HUMAN	IC50	4.47	CHEMBL
Substance-K receptor	GPCR	P21452	NK2R_HUMAN	Ki	6.06	DRUG MATRIX

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External reference:

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ID	Source
RIT	PDB_CHEM_ID
005554	NDDF
108693005	SNOMEDCT_US
196479	RXNORM
251788	MMSL
386896009	SNOMEDCT_US
392622	PUBCHEM_CID
4020963	VUID
4020963	VANDF
5431	MMSL

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Kaletra	HUMAN PRESCRIPTION DRUG LABEL	2	0074-0522	TABLET, FILM COATED	25 mg	ORAL	NDA	32 sections
Kaletra	HUMAN PRESCRIPTION DRUG LABEL	2	0074-0522	TABLET, FILM COATED	25 mg	ORAL	NDA	32 sections
Kaletra	HUMAN PRESCRIPTION DRUG LABEL	2	0074-1575	TABLET, FILM COATED	25 mg	ORAL	NDA	32 sections
Kaletra	HUMAN PRESCRIPTION DRUG LABEL	2	0074-1575	TABLET, FILM COATED	25 mg	ORAL	NDA	32 sections
Kaletra	HUMAN PRESCRIPTION DRUG LABEL	2	0074-2605	TABLET, FILM COATED	50 mg	ORAL	NDA	32 sections
Kaletra	HUMAN PRESCRIPTION DRUG LABEL	2	0074-2605	TABLET, FILM COATED	50 mg	ORAL	NDA	32 sections
Kaletra	HUMAN PRESCRIPTION DRUG LABEL	2	0074-3008	TABLET, FILM COATED	25 mg	ORAL	NDA	32 sections
Kaletra	HUMAN PRESCRIPTION DRUG LABEL	2	0074-3956	SOLUTION	20 mg	ORAL	NDA	32 sections
Kaletra	HUMAN PRESCRIPTION DRUG LABEL	2	0074-3956	SOLUTION	20 mg	ORAL	NDA	32 sections
Kaletra	HUMAN PRESCRIPTION DRUG LABEL	2	0074-4014	TABLET, FILM COATED	50 mg	ORAL	NDA	32 sections

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