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Details for Generic Name: atovaquone; proguanil hydrochloride

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Atovaquone; proguanil hydrochloride is the generic ingredient in three branded drugs marketed by Glenmark Generics, Mylan Pharms Inc, and Glaxosmithkline, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for atovaquone; proguanil hydrochloride. Five suppliers are listed for this compound.

Summary for Generic Name: atovaquone; proguanil hydrochloride

Tradenames:3
Patents:0
Applicants:3
NDAs:3
Drug Master File Entries: see list14
Suppliers / Packaging: see list16
Therapeutic Class:Antiparasitics

Pharmacology for Ingredient: atovaquone; proguanil hydrochloride

Clinical Trials for: atovaquone; proguanil hydrochloride

Single Oral Dose Study of Atovaquone/Proguanil Hydrochloride Combination Tablets and Atovaquone Suspension
Status: Completed Condition: Malaria

The ASAP Study - Therapeutic Efficacy of Atovaquone-proguanil vs. Artesunate-atovaquone-proguanil in Cambodia
Status: Completed Condition: Malaria

Chloroquine Alone or in Combination for Malaria in Children in Malawi
Status: Completed Condition: Plasmodium Falciparum Infection

Weekly Dosing of Malarone ® for Prevention of Malaria
Status: Completed Condition: Malaria

Azithromycin Plus Chloroquine Versus Atovaquone-Proguanil For The Treatment Of Uncomplicated Plasmodium Falciparum Malaria In South America
Status: Completed Condition: Malaria, Falciparum

Evaluation of Potential Effect of Artemether - Lumefantrine and Malaria Drugs on Auditory Function
Status: Completed Condition: Malaria; Falciparum

Evaluation of the Riamet® Versus Malarone® in the Treatment of Uncomplicated Malaria
Status: Completed Condition: Malaria

Drug Interaction Study Between Atovaquone and Antiretroviral Agents in HIV-1 Infected Patients
Status: Completed Condition: HIV Infections; Malaria

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glenmark Generics
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE
atovaquone; proguanil hydrochloride
TABLET;ORAL091211-002Apr 6, 2015RXNo<disabled><disabled>
Glaxosmithkline
MALARONE
atovaquone; proguanil hydrochloride
TABLET;ORAL021078-001Jul 14, 2000RXYes<disabled><disabled>
Glaxosmithkline
MALARONE PEDIATRIC
atovaquone; proguanil hydrochloride
TABLET;ORAL021078-002Jul 14, 2000RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: atovaquone; proguanil hydrochloride

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline
MALARONE
atovaquone; proguanil hydrochloride
TABLET;ORAL021078-001Jul 14, 20005,053,432*PED<disabled>
Glaxosmithkline
MALARONE PEDIATRIC
atovaquone; proguanil hydrochloride
TABLET;ORAL021078-002Jul 14, 20006,291,488*PED<disabled>
Glaxosmithkline
MALARONE PEDIATRIC
atovaquone; proguanil hydrochloride
TABLET;ORAL021078-002Jul 14, 20006,166,046*PED<disabled>
This preview shows a limited data set
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

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Copyright 2002-2016 thinkBiotech LLC
ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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