Atovaquone; proguanil hydrochloride - Generic Drug Details

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What are the generic sources for atovaquone; proguanil hydrochloride and what is the scope of patent protection?

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

Ten suppliers are listed for this compound.

Summary for atovaquone; proguanil hydrochloride

US Patents:	0
Tradenames:	3
Applicants:	3
NDAs:	3
Finished Product Suppliers / Packagers:	10
Clinical Trials:	25
DailyMed Link:	atovaquone; proguanil hydrochloride at DailyMed

Recent Clinical Trials for atovaquone; proguanil hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Australian Defence Force Malaria and Infectious Disease Institute (ADF MIDI)	Phase 4
Naval Medical Research Unit TWO (NAMRU-2)	Phase 4
Naval Medical Research Center	Phase 4

See all atovaquone; proguanil hydrochloride clinical trials

Pharmacology for atovaquone; proguanil hydrochloride

Drug Class	Antimalarial Antiprotozoal
Mechanism of Action	Dihydrofolate Reductase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for atovaquone; proguanil hydrochloride

P01AX	Other agents against amoebiasis and other protozoal diseases
P01A	AGENTS AGAINST AMOEBIASIS AND OTHER PROTOZOAL DISEASES
P01	ANTIPROTOZOALS
P	Antiparasitic products, insecticides and repellents

P01BB	Biguanides
P01B	ANTIMALARIALS
P01	ANTIPROTOZOALS
P	Antiparasitic products, insecticides and repellents

Paragraph IV (Patent) Challenges for ATOVAQUONE; PROGUANIL HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MALARONE PEDIATRIC	Tablets	atovaquone; proguanil hydrochloride	62.5 mg/25 mg	021078	1	2010-09-14
MALARONE PEDIATRIC	Tablets	atovaquone; proguanil hydrochloride	250 mg/100 mg	021078	1	2009-04-03

US Patents and Regulatory Information for atovaquone; proguanil hydrochloride

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glenmark Pharms Ltd	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	atovaquone; proguanil hydrochloride	TABLET;ORAL	091211-002	Apr 6, 2015	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glaxosmithkline	MALARONE	atovaquone; proguanil hydrochloride	TABLET;ORAL	021078-001	Jul 14, 2000	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	atovaquone; proguanil hydrochloride	TABLET;ORAL	202362-001	May 27, 2014	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for 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;ORAL	021078-001	Jul 14, 2000	⤷ Sign Up	⤷ Sign Up
Glaxosmithkline	MALARONE	atovaquone; proguanil hydrochloride	TABLET;ORAL	021078-001	Jul 14, 2000	⤷ Sign Up	⤷ Sign Up
Glaxosmithkline	MALARONE PEDIATRIC	atovaquone; proguanil hydrochloride	TABLET;ORAL	021078-002	Jul 14, 2000	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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