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Atovaquone - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for atovaquone?

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

There are fifteen drug master file entries for atovaquone. Four suppliers are listed for this compound.

Summary for Generic Name: atovaquone

Tradenames:5
Patents:2
Applicants:5
NDAs:6
Drug Master File Entries: see list15
Suppliers / Packagers: see list4
Bulk Api Vendors: see list73
Clinical Trials: see list10
Patent Applications: see list4,278
Therapeutic Class:Antiparasitics
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:atovaquone at DailyMed

Pharmacology for Ingredient: atovaquone

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline
MALARONE PEDIATRIC
atovaquone; proguanil hydrochloride
TABLET;ORAL021078-002Jul 14, 2000RXYesNo► Subscribe► Subscribe
Glaxosmithkline Llc
MEPRON
atovaquone
SUSPENSION;ORAL020500-001Feb 8, 1995RXYesYes6,649,659*PED► SubscribeY► Subscribe
Glaxosmithkline
MALARONE
atovaquone; proguanil hydrochloride
TABLET;ORAL021078-001Jul 14, 2000RXYesYes► Subscribe► Subscribe
Mylan Pharms Inc
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE
atovaquone; proguanil hydrochloride
TABLET;ORAL202362-001May 27, 2014RXNoNo► Subscribe► Subscribe
Glenmark Generics
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE
atovaquone; proguanil hydrochloride
TABLET;ORAL091211-002Apr 6, 2015RXNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: atovaquone

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline Llc
MEPRON
atovaquone
SUSPENSION;ORAL020500-001Feb 8, 19954,981,874*PED► Subscribe
Glaxosmithkline Llc
MEPRON
atovaquone
SUSPENSION;ORAL020500-001Feb 8, 19955,053,432*PED► Subscribe
Glaxosmithkline Llc
MEPRON
atovaquone
TABLET;ORAL020259-001Nov 25, 19925,053,432*PED► Subscribe
Glaxosmithkline Llc
MEPRON
atovaquone
TABLET;ORAL020259-001Nov 25, 19924,981,874*PED► Subscribe
Glaxosmithkline Llc
MEPRON
atovaquone
SUSPENSION;ORAL020500-001Feb 8, 19956,649,659*PED► Subscribe
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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. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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