Lopinavir - PharmaKB

Kaletra(lopinavir)

Kaletra, Lopinavir / Ritonavir, Lopinavir/Ritonavir Mylan (lopinavir) is a small molecule pharmaceutical. Lopinavir was first approved as Kaletra on 2000-09-15. It is used to treat acquired immunodeficiency syndrome in the USA. It has been approved in Europe to treat HIV infections.

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Commercial

Clinical

Drug

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Variants

Financial

Trends

Safety

Events Timeline

YTD

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Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

Start date

Primary completion date

Completion date

Results first post date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
infections	D007239
urogenital diseases	D000091642
immune system diseases	D007154

Trade Name

FDA

EMA

Combinations

Kaletra, Lopinavir ritonavir (discontinued: Kaletra, Lopinavir ritonavir)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Lopinavir

Ritonavir

Tradename	Company	Number	Date	Products
KALETRA	AbbVie	N-021251 RX	2000-09-15	1 products, RLD, RS
KALETRA	AbbVie	N-021906 RX	2005-10-28	2 products, RLD, RS

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Labels

FDA

EMA

Brand Name	Status	Last Update
kaletra	New Drug Application	2023-07-06
lopinavir and ritonavir	ANDA	2023-10-20

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
acquired immunodeficiency syndrome	EFO_0000765	D000163	B20

Agency Specific

FDA

EMA

No data

Patent Expiration

No data

ATC Codes

J: Antiinfectives for systemic use

— J05: Antivirals for systemic use

— J05A: Direct acting antivirals

— J05AR: Antivirals for treatment of hiv infections, combinations

— J05AR10: Lopinavir and ritonavir

HCPCS

No data

Clinical

Clinical Trials

438 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	23	62	79	69	58	274
Acquired immunodeficiency syndrome	D000163	EFO_0000765	B20	7	8	19	20	19	70
Covid-19	D000086382	—	U07.1	1	22	27	5	18	63
Hiv	D006678	—	O98.7	10	9	10	20	15	60
Infections	D007239	EFO_0000544	—	4	6	11	4	10	34
Coronavirus infections	D018352	EFO_0007224	B34.2	—	8	6	1	7	20
Tuberculosis	D014376	EFO_0000774	A15-A19	3	6	—	4	1	14
Pneumonia	D011014	EFO_0003106	J18	—	3	3	2	7	13
Healthy volunteers/patients	—	—	—	7	—	—	3	2	12
Hepatitis c	D006526	—	B19.2	2	2	2	1	4	11

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Severe acute respiratory syndrome	D045169	EFO_0000694	J12.81	—	1	3	—	2	5
Hepatitis	D006505	—	K75.9	—	1	2	—	2	5
Respiratory distress syndrome	D012128	EFO_1000637	J80	1	1	1	—	3	5
Virus diseases	D014777	—	B34	—	1	1	—	3	5
Hepatitis a	D006506	EFO_0007305	B15	—	1	1	—	2	4
Respiratory tract infections	D012141	—	J06.9	—	—	2	—	—	2
Community-acquired pneumonia	D000098968	—	—	—	—	2	—	—	2
Respiratory tract diseases	D012140	—	—	—	—	1	—	—	1
Lung diseases	D008171	EFO_0003818	J98.4	—	—	1	—	—	1
Human influenza	D007251	EFO_0007328	J11.1	—	—	1	—	—	1

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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
Hepatitis b	D006509	—	—	—	1	—	—	1	2
Syndrome	D013577	—	—	1	1	—	—	1	2
Drug-related side effects and adverse reactions	D064420	—	T88.7	—	1	—	—	1	2
Neoplasms	D009369	—	C80	1	2	—	—	—	2
Renal insufficiency	D051437	—	N19	—	1	—	—	—	1
Viremia	D014766	—	B34.9	—	1	—	—	—	1
Liver cirrhosis	D008103	EFO_0001422	K74.0	—	1	—	—	—	1
Fibrosis	D005355	—	—	—	1	—	—	—	1

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Pharmacokinetics	D010599	—	—	1	—	—	—	1	2
Insulin resistance	D007333	EFO_0002614	E88.819	1	—	—	—	1	2
Long qt syndrome	D008133	HP_0001657	I45.81	1	—	—	—	—	1
Pharmacological phenomena	D000069437	—	—	1	—	—	—	—	1
Therapeutic equivalency	D013810	—	—	1	—	—	—	—	1
Hypertriglyceridemia	D015228	EFO_0004211	—	1	—	—	—	—	1
Squamous intraepithelial lesions of the cervix	D065310	—	—	1	—	—	—	—	1
Inflammation	D007249	MP_0001845	—	1	—	—	—	—	1
Therapeutics	D013812	—	—	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Diabetes mellitus	D003920	EFO_0000400	E08-E13	—	—	—	—	2	2
Chronic hepatitis c	D019698	EFO_0004220	B18.2	—	—	—	—	1	1
Chronic hepatitis b	D019694	EFO_0004239	B18.1	—	—	—	—	1	1
Wasting syndrome	D019282	—	—	—	—	—	—	1	1
Cachexia	D002100	—	R64	—	—	—	—	1	1
Hemorrhage	D006470	MP_0001914	R58	—	—	—	—	1	1
Heart failure	D006333	EFO_0003144	I50	—	—	—	—	1	1
Hypertension	D006973	EFO_0000537	I10	—	—	—	—	1	1
Menorrhagia	D008595	EFO_0003945	N92.0	—	—	—	—	1	1
Hemophilia a	D006467	EFO_0007267	D66	—	—	—	—	1	1

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Lopinavir
INN	lopinavir
Description	Lopinavir is a dicarboxylic acid diamide that is amphetamine is substituted on nitrogen by a (2,6-dimethylphenoxy)acetyl group and on the carbon alpha- to nitrogen by a (1S,3S)-1-hydroxy-3-{[(2S)-3-methyl-2-(2-oxotetrahydropyrimidin-1-yl)butanoyl]amino}-4-phenylbutyl group. An antiretroviral of the protease inhibitor class, it is used against HIV infections as a fixed-dose combination with another protease inhibitor, ritonavir. It has a role as an antiviral drug, a HIV protease inhibitor and an anticoronaviral agent. It is a member of amphetamines and a dicarboxylic acid diamide.
Classification	Small molecule
Drug class	antivirals: HIV protease inhibitors (saquinavir type)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	Cc1cccc(C)c1OCC(=O)N[C@@H](Cc1ccccc1)[C@@H](O)C[C@H](Cc1ccccc1)NC(=O)[C@H](C(C)C)N1CCCNC1=O