➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

McKinsey
Harvard Business School
Moodys
McKesson
Merck
Colorcon

Last Updated: September 29, 2020

DrugPatentWatch Database Preview

MALARONE Drug Profile

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

When do Malarone patents expire, and when can generic versions of Malarone launch?

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

The generic ingredient in MALARONE 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
Drug Prices for MALARONE

See drug prices for MALARONE

Recent Clinical Trials for MALARONE

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

SponsorPhase
Institute of Tropical Medicine, BelgiumPhase 1
SGS Life SciencesPhase 1
Iqvia Pty LtdPhase 1

See all MALARONE clinical trials

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

US Patents and Regulatory Information for MALARONE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline MALARONE atovaquone; proguanil hydrochloride TABLET;ORAL 021078-001 Jul 14, 2000 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline MALARONE atovaquone; proguanil hydrochloride TABLET;ORAL 021078-001 Jul 14, 2000   Start Trial   Start Trial
Glaxosmithkline MALARONE atovaquone; proguanil hydrochloride TABLET;ORAL 021078-001 Jul 14, 2000   Start Trial   Start Trial
Glaxosmithkline MALARONE atovaquone; proguanil hydrochloride TABLET;ORAL 021078-001 Jul 14, 2000   Start Trial   Start Trial
Glaxosmithkline MALARONE atovaquone; proguanil hydrochloride TABLET;ORAL 021078-001 Jul 14, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for MALARONE

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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School
McKinsey
Merck
Boehringer Ingelheim
Express Scripts
Colorcon

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 verification 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.