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Last Updated: March 28, 2024

Atovaquone - Generic Drug Details


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What are the generic sources for atovaquone and what is the scope of freedom to operate?

Atovaquone is the generic ingredient in five branded drugs marketed by Abhai Llc, Abon Pharms Llc, Amneal Pharms, Apotex, Bionpharma, Chartwell Rx, Glenmark Pharms, Hetero Labs Ltd Iii, Lupin Ltd, Glaxosmithkline Llc, Glenmark Generics, Mylan, and Glaxosmithkline, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for atovaquone. Sixteen suppliers are listed for this compound.

Drug Prices for atovaquone

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Recent Clinical Trials for atovaquone

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

SponsorPhase
The 108 Military Central HospitalPhase 4
Australian Defence Force Malaria and Infectious Disease Institute (ADF MIDI)Phase 4
Naval Medical Research Unit TWO (NAMRU-2)Phase 4

See all atovaquone clinical trials

Pharmacology for atovaquone
Medical Subject Heading (MeSH) Categories for atovaquone
Paragraph IV (Patent) Challenges for ATOVAQUONE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
MEPRON Oral Suspension atovaquone 750 mg/5 mL 020500 1 2009-10-20

US Patents and Regulatory Information for atovaquone

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Chartwell Rx ATOVAQUONE atovaquone SUSPENSION;ORAL 207833-001 Apr 28, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amneal Pharms ATOVAQUONE atovaquone SUSPENSION;ORAL 202960-001 Mar 18, 2014 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Abon Pharms Llc ATOVAQUONE atovaquone SUSPENSION;ORAL 214272-001 Oct 25, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bionpharma ATOVAQUONE atovaquone SUSPENSION;ORAL 212918-001 Mar 30, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hetero Labs Ltd Iii ATOVAQUONE atovaquone SUSPENSION;ORAL 210692-001 Oct 11, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Glenmark Pharms ATOVAQUONE atovaquone SUSPENSION;ORAL 209685-001 Nov 21, 2018 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline Llc MEPRON atovaquone SUSPENSION;ORAL 020500-001 Feb 8, 1995 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline Llc MEPRON atovaquone SUSPENSION;ORAL 020500-001 Feb 8, 1995 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline Llc MEPRON atovaquone TABLET;ORAL 020259-001 Nov 25, 1992 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline Llc MEPRON atovaquone TABLET;ORAL 020259-001 Nov 25, 1992 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline Llc MEPRON atovaquone SUSPENSION;ORAL 020500-001 Feb 8, 1995 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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