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MALARONE Drug Profile

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Malarone is a drug marketed by Glaxosmithkline and is included in one NDA. It is available from three suppliers.

The generic ingredient in MALARONE is atovaquone; proguanil hydrochloride. There are fourteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the atovaquone; proguanil hydrochloride profile page.

Summary for Tradename: MALARONE

Patents:0
Applicants:1
NDAs:1
Suppliers / Packagers: see list3
Formulation / Manufacturing:see details

Pharmacology for Tradename: MALARONE

Clinical Trials for: MALARONE

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
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 Patents for Tradename: MALARONE

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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
atovaquone; proguanil hydrochloride
TABLET;ORAL021078-001Jul 14, 20006,166,046*PED<disabled>
Glaxosmithkline
MALARONE
atovaquone; proguanil hydrochloride
TABLET;ORAL021078-001Jul 14, 20005,998,449*PED<disabled>
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Paragraph IV activity for: MALARONE

Drugname Dosage Strength RLD Submissiondate
atovaquone and proguanil hydrochlorideTablets62.5 mg/25 mgMalarone9/14/2010
atovaquone and proguanil hydrochlorideTablets250 mg/100 mgMalarone4/3/2009
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