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Last Updated: March 28, 2024

Atovaquone; proguanil hydrochloride - Generic Drug Details


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What are the generic drug 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.

Nine 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
Naval Medical Research Unit TWO (NAMRU-2)Phase 4
Naval Medical Research CenterPhase 4
Naval Environmental Preventive Medicine Unit TWO (NEPMU-2)Phase 4

See all atovaquone; proguanil hydrochloride clinical trials

Pharmacology for atovaquone; proguanil hydrochloride
Paragraph IV (Patent) Challenges for ATOVAQUONE; PROGUANIL HYDROCHLORIDE
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 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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan ATOVAQUONE AND PROGUANIL HYDROCHLORIDE atovaquone; proguanil hydrochloride TABLET;ORAL 202362-001 May 27, 2014 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Glenmark Generics ATOVAQUONE AND PROGUANIL HYDROCHLORIDE atovaquone; proguanil hydrochloride TABLET;ORAL 091211-001 Jan 12, 2011 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline MALARONE atovaquone; proguanil hydrochloride TABLET;ORAL 021078-001 Jul 14, 2000 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan ATOVAQUONE AND PROGUANIL HYDROCHLORIDE atovaquone; proguanil hydrochloride TABLET;ORAL 202362-002 May 27, 2014 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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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