MALARONE PEDIATRIC Drug Patent Profile

Which patents cover Malarone Pediatric, and what generic alternatives are available?

Malarone Pediatric is a drug marketed by Glaxosmithkline and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Malarone Pediatric

A generic version of MALARONE PEDIATRIC was approved as atovaquone; proguanil hydrochloride by GLENMARK PHARMS LTD on January 12^th, 2011.

Summary for MALARONE PEDIATRIC

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	22
Patent Applications:	1
Drug Prices:	Drug price information for MALARONE PEDIATRIC
DailyMed Link:	MALARONE PEDIATRIC at DailyMed

See drug prices for MALARONE PEDIATRIC

Recent Clinical Trials for MALARONE PEDIATRIC

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 MALARONE PEDIATRIC clinical trials

Pharmacology for MALARONE PEDIATRIC

Drug Class	Antimalarial Antiprotozoal
Mechanism of Action	Dihydrofolate Reductase Inhibitors

Paragraph IV (Patent) Challenges for MALARONE PEDIATRIC

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 MALARONE PEDIATRIC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	MALARONE PEDIATRIC	atovaquone; proguanil hydrochloride	TABLET;ORAL	021078-002	Jul 14, 2000	AB	RX	Yes	No

Expired US Patents for MALARONE PEDIATRIC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	MALARONE PEDIATRIC	atovaquone; proguanil hydrochloride	TABLET;ORAL	021078-002	Jul 14, 2000
Glaxosmithkline	MALARONE PEDIATRIC	atovaquone; proguanil hydrochloride	TABLET;ORAL	021078-002	Jul 14, 2000
Glaxosmithkline	MALARONE PEDIATRIC	atovaquone; proguanil hydrochloride	TABLET;ORAL	021078-002	Jul 14, 2000
Glaxosmithkline	MALARONE PEDIATRIC	atovaquone; proguanil hydrochloride	TABLET;ORAL	021078-002	Jul 14, 2000

International Patents for MALARONE PEDIATRIC

See the table below for patents covering MALARONE PEDIATRIC around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0123238	NAPHTHOQUINONE DERIVATIVES
Slovakia	281559
Czech Republic	9501192
Czech Republic	289692	Farmaceutická kombinace 2-/4-(4-chlorfenyl)-cyklohexyl/-3-hydroxy-1,4-naftochinonu a proguanilu a farmaceutický prostředek (Pharmaceutical combination of 2-[4-(4-chlorophenyl)cyclohexyl]-3-hydroxy-1,4-naphthoquinone and proguanil and pharmaceutical preparation)
Hungary	225918	COMBINATION OF ATOVAQUONE WITH PROGUANIL FOR THE TREATMENT OF PROTOZOAL INFECTIONS AND P. CARINII
African Intellectual Property Organization (OAPI)	10352	Combination of atovaquone with proguanil for the treatment of protozoal infections

Supplementary Protection Certificates for MALARONE PEDIATRIC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0123238	95C0009	Belgium		PRODUCT NAME: ATOVAQUONUM; NATIONAL REGISTRTION NO/DATE: 251 IS 151 F 3 19950710; FIRST REGISTRATION: LU 0458/94/08/0741 19940803
0123238	SPC/GB95/004	United Kingdom		PRODUCT NAME: ATOVAQUONE OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY ACCEPTABLE SALT; REGISTERED: LU 0458/94/08/0741 19940803; UK 0003/0337 19940823