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Last Updated: August 17, 2022

Pretomanid - Generic Drug Details


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

Pretomanid is the generic ingredient in one branded drug marketed by Mylan Ireland Ltd and is included in one NDA. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for pretomanid
Drug Prices for pretomanid

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Recent Clinical Trials for pretomanid

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SponsorPhase
International Tuberculosis Research CenterPhase 4
Seoul National University HospitalPhase 4
Masan National Tuberculosis HospitalPhase 4

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US Patents and Regulatory Information for pretomanid

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Ireland Ltd PRETOMANID pretomanid TABLET;ORAL 212862-001 Aug 14, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan Ireland Ltd PRETOMANID pretomanid TABLET;ORAL 212862-001 Aug 14, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan Ireland Ltd PRETOMANID pretomanid TABLET;ORAL 212862-001 Aug 14, 2019 RX Yes Yes 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

EU/EMA Drug Approvals for pretomanid

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Mylan Ireland Limited Dovprela (previously Pretomanid FGK) pretomanid EMEA/H/C/005167
Dovprela is indicated in combination with bedaquiline and linezolid, in adults, for the treatment of pulmonary extensively drug resistant (XDR), or treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB)., , Consideration should be given to official guidance on the appropriate use of antibacterial agents.,
Authorised no no yes 2020-07-31
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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