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Atovaquone; proguanil hydrochloride - Generic Drug Details

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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. Thirteen 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 list13
Therapeutic Class:Antiparasitics
Formulation / Manufacturing:see details

Pharmacology for Ingredient: atovaquone; proguanil hydrochloride

Clinical Trials for: atovaquone; proguanil hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline
MALARONE PEDIATRIC
atovaquone; proguanil hydrochloride
TABLET;ORAL021078-002Jul 14, 2000RXNo<disabled><disabled>
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>
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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 PEDIATRIC
atovaquone; proguanil hydrochloride
TABLET;ORAL021078-002Jul 14, 20006,291,488*PED<disabled>
Glaxosmithkline
MALARONE
atovaquone; proguanil hydrochloride
TABLET;ORAL021078-001Jul 14, 20005,053,432*PED<disabled>
Glaxosmithkline
MALARONE PEDIATRIC
atovaquone; proguanil hydrochloride
TABLET;ORAL021078-002Jul 14, 20005,053,432*PED<disabled>
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