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Last Updated: August 12, 2020

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MALARONE PEDIATRIC Drug Profile

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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.

Drug patent expirations by year for MALARONE PEDIATRIC
Drug Prices for MALARONE PEDIATRIC

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Recent Clinical Trials for MALARONE PEDIATRIC

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SponsorPhase
Iqvia Pty LtdPhase 1
Swiss BioQuant A.G., SwitzerlandPhase 1
FGK Representative Service B.V., The NetherlandsPhase 1

See all MALARONE PEDIATRIC clinical trials

Pharmacology for MALARONE PEDIATRIC
Paragraph IV (Patent) Challenges for MALARONE PEDIATRIC
Tradename Dosage Ingredient NDA Submissiondate
MALARONE PEDIATRIC TABLET;ORAL atovaquone; proguanil hydrochloride 021078 2010-09-14
MALARONE TABLET;ORAL atovaquone; proguanil hydrochloride 021078 2010-09-14
MALARONE TABLET;ORAL atovaquone; proguanil hydrochloride 021078 2009-04-03
MALARONE PEDIATRIC TABLET;ORAL atovaquone; proguanil hydrochloride 021078 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   Start Trial   Start Trial   Start Trial
>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 MALARONE PEDIATRIC

Supplementary Protection Certificates for MALARONE PEDIATRIC

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

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Serving leading biopharmaceutical companies globally:

Medtronic
Johnson and Johnson
Harvard Business School
McKesson
Express Scripts
AstraZeneca

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