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Last Updated: November 4, 2024

MALARONE Drug Patent Profile


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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.

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Summary for MALARONE
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
Naval Environmental Preventive Medicine Unit TWO (NEPMU-2)Phase 4
The 108 Military Central HospitalPhase 4
Australian Defence Force Malaria and Infectious Disease Institute (ADF MIDI)Phase 4

See all MALARONE clinical trials

Pharmacology for MALARONE

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

International Patents for MALARONE

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

Country Patent Number Title Estimated Expiration
Portugal 670719 ⤷  Sign Up
South Africa 9308832 ⤷  Sign Up
Norway 951995 ⤷  Sign Up
Czech Republic 289171 Kombinace 2-/4-(4-chlorfenyl)cyklohexyl/-3-hydroxy-1,4-naftochinonu a proguanilu pro léčení protozoálních parazitických infekcí (Combination of 2-/4-(4-chlorophenyl)cyclohexyl/-3-hydroxy-1,4-naphthoquinone and proguanil for treating protozoal parasitic infections) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for MALARONE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0123238 SPC/GB95/004 United Kingdom ⤷  Sign Up 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 ⤷  Sign Up 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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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.