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Details for Generic Name: atovaquone

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Atovaquone is the generic ingredient in five branded drugs marketed by Amneal Pharms, Glaxosmithkline Llc, Glenmark Generics, Mylan Pharms Inc, and Glaxosmithkline, and is included in six NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for atovaquone. Three suppliers are listed for this compound.

Summary for Generic Name: atovaquone

Drug Master File Entries: see list14
Suppliers / Packaging: see list5
Therapeutic Class:Antiparasitics

Pharmacology for Ingredient: atovaquone

Clinical Trials for: atovaquone

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: Recruiting Condition: Malaria

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

Antiretroviral Drug Interaction Study in Volunteers With HIV
Status: Completed Condition: HIV; PCP; Toxoplasmosis

Phase II Randomized Open-Label Trial of Atovaquone Plus Pyrimethamine and Atovaquone Plus Sulfadiazine for the Treatment of Acute Toxoplasmic Encephalitis
Status: Completed Condition: Toxoplasmosis, Cerebral; HIV Infections

Phase I Safety and Pharmacokinetics Study of Microparticulate Atovaquone (m-Atovaquone; 566C80) in HIV-Infected and Perinatally Exposed Infants and Children
Status: Completed Condition: Pneumonia, Pneumocystis Carinii; HIV Infections

Courtesy of
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; proguanil hydrochloride
TABLET;ORAL091211-002Apr 6, 2015RXNo<disabled><disabled>
Mylan Pharms Inc
atovaquone; proguanil hydrochloride
TABLET;ORAL202362-002May 27, 2014RXNo<disabled><disabled>
Mylan Pharms Inc
atovaquone; proguanil hydrochloride
TABLET;ORAL202362-001May 27, 2014RXNo<disabled><disabled>
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Preferred citation:

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

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