ATOVAQUONE - Generic Drug Details

What are the generic drug sources for atovaquone and what is the scope of patent protection?

Atovaquone is the generic ingredient in five branded drugs marketed by Abhai Llc, Abon Pharms Llc, Amneal Pharms, Apotex, Bionpharma, Chartwell Rx, Glenmark Speclt, Hetero Labs Ltd Iii, Lupin Ltd, Glaxosmithkline Llc, Glenmark Pharms Ltd, Mylan, and Glaxosmithkline, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for atovaquone. Nineteen suppliers are listed for this compound.

Summary for ATOVAQUONE

US Patents:	0
Tradenames:	5
Applicants:	13
NDAs:	14
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	166
Clinical Trials:	42
Patent Applications:	6,930
Drug Prices:	Drug price trends for ATOVAQUONE
What excipients (inactive ingredients) are in ATOVAQUONE?	ATOVAQUONE excipients list
DailyMed Link:	ATOVAQUONE at DailyMed

See drug prices for ATOVAQUONE

Recent Clinical Trials for ATOVAQUONE

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

Sponsor	Phase
Naval Medical Research Center	Phase 4
Naval Environmental Preventive Medicine Unit TWO (NEPMU-2)	Phase 4
The 108 Military Central Hospital	Phase 4

See all ATOVAQUONE clinical trials

Pharmacology for ATOVAQUONE

Drug Class

Antimalarial Antiprotozoal

Medical Subject Heading (MeSH) Categories for ATOVAQUONE

Anti-Infective Agents

Antimalarials

Enzyme Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ATOVAQUONE

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

Paragraph IV (Patent) Challenges for ATOVAQUONE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MEPRON	Oral Suspension	atovaquone	750 mg/5 mL	020500	1	2009-10-20

US Patents and Regulatory Information for ATOVAQUONE

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	091211-001	Jan 12, 2011	AB	RX	No	No
Glenmark Pharms Ltd	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	atovaquone; proguanil hydrochloride	TABLET;ORAL	091211-002	Apr 6, 2015	AB	RX	No	No
Mylan	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	atovaquone; proguanil hydrochloride	TABLET;ORAL	202362-002	May 27, 2014	AB	RX	No	No
Glaxosmithkline	MALARONE	atovaquone; proguanil hydrochloride	TABLET;ORAL	021078-001	Jul 14, 2000	AB	RX	Yes	Yes
Abhai Llc	ATOVAQUONE	atovaquone	SUSPENSION;ORAL	210510-001	May 31, 2019	AB	RX	No	No
Glaxosmithkline Llc	MEPRON	atovaquone	TABLET;ORAL	020259-001	Nov 25, 1992		DISCN	Yes	No
Glenmark Speclt	ATOVAQUONE	atovaquone	SUSPENSION;ORAL	209685-001	Nov 21, 2018	AB	RX	No	No

Expired US Patents for ATOVAQUONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline Llc	MEPRON	atovaquone	SUSPENSION;ORAL	020500-001	Feb 8, 1995
Glaxosmithkline Llc	MEPRON	atovaquone	TABLET;ORAL	020259-001	Nov 25, 1992
Glaxosmithkline Llc	MEPRON	atovaquone	TABLET;ORAL	020259-001	Nov 25, 1992
Glaxosmithkline Llc	MEPRON	atovaquone	SUSPENSION;ORAL	020500-001	Feb 8, 1995
Glaxosmithkline Llc	MEPRON	atovaquone	SUSPENSION;ORAL	020500-001	Feb 8, 1995