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Last Updated: August 12, 2020

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Atovaquone; proguanil hydrochloride - Generic Drug Details

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What are the generic sources for atovaquone; proguanil hydrochloride and what is the scope of patent protection?

Atovaquone; proguanil hydrochloride is the generic ingredient in three branded drugs marketed by Glenmark Generics, Mylan, and Glaxosmithkline, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for atovaquone; proguanil hydrochloride. Ten suppliers are listed for this compound.

Summary for atovaquone; proguanil hydrochloride
Recent Clinical Trials for atovaquone; proguanil hydrochloride

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

SponsorPhase
Richmond Pharmacology LimitedPhase 1
National Center for Parasitology, Entomology and Malaria ControlPhase 4
Radboud UniversityN/A

See all atovaquone; proguanil hydrochloride clinical trials

Pharmacology for atovaquone; proguanil hydrochloride
Paragraph IV (Patent) Challenges for ATOVAQUONE; PROGUANIL HYDROCHLORIDE
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 atovaquone; proguanil hydrochloride

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
Glenmark Generics ATOVAQUONE AND PROGUANIL HYDROCHLORIDE atovaquone; proguanil hydrochloride TABLET;ORAL 091211-002 Apr 6, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan ATOVAQUONE AND PROGUANIL HYDROCHLORIDE atovaquone; proguanil hydrochloride TABLET;ORAL 202362-002 May 27, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan ATOVAQUONE AND PROGUANIL HYDROCHLORIDE atovaquone; proguanil hydrochloride TABLET;ORAL 202362-001 May 27, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Glaxosmithkline MALARONE atovaquone; proguanil hydrochloride TABLET;ORAL 021078-001 Jul 14, 2000 AB RX Yes Yes   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 atovaquone; proguanil hydrochloride

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Serving leading biopharmaceutical companies globally:

McKesson
Mallinckrodt
Dow
AstraZeneca
Express Scripts
Moodys

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