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Last Updated: May 20, 2022

Atovaquone - Generic Drug Details


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What are the generic drug sources for atovaquone and what is the scope of patent protection?

Atovaquone is the generic ingredient in five branded drugs marketed by Abhai Llc, Abon Pharms Llc, Amneal Pharms, Apotex, Bionpharma Inc, Glenmark Pharms, Hetero Labs Ltd Iii, Lupin Ltd, Padagis Us, 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. Fifteen 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
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 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
Hetero Labs Ltd Iii ATOVAQUONE atovaquone SUSPENSION;ORAL 210692-001 Oct 11, 2018 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan ATOVAQUONE AND PROGUANIL HYDROCHLORIDE atovaquone; proguanil hydrochloride TABLET;ORAL 202362-001 May 27, 2014 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Glenmark Pharms ATOVAQUONE atovaquone SUSPENSION;ORAL 209685-001 Nov 21, 2018 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Glaxosmithkline Llc MEPRON atovaquone SUSPENSION;ORAL 020500-001 Feb 8, 1995 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan ATOVAQUONE AND PROGUANIL HYDROCHLORIDE atovaquone; proguanil hydrochloride TABLET;ORAL 202362-002 May 27, 2014 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Glaxosmithkline Llc MEPRON atovaquone SUSPENSION;ORAL 020500-001 Feb 8, 1995 See Plans and Pricing See Plans and Pricing
Glaxosmithkline Llc MEPRON atovaquone TABLET;ORAL 020259-001 Nov 25, 1992 See Plans and Pricing See Plans and Pricing
Glaxosmithkline Llc MEPRON atovaquone SUSPENSION;ORAL 020500-001 Feb 8, 1995 See Plans and Pricing See Plans and Pricing
Glaxosmithkline Llc MEPRON atovaquone TABLET;ORAL 020259-001 Nov 25, 1992 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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