You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: June 14, 2024

PRETOMANID Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Pretomanid, and when can generic versions of Pretomanid launch?

Pretomanid is a drug marketed by Mylan Ireland Ltd and is included in one NDA.

The generic ingredient in PRETOMANID is pretomanid. One supplier is listed for this compound. Additional details are available on the pretomanid profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Pretomanid

A generic version of PRETOMANID was approved as pretomanid by MYLAN IRELAND LTD on August 14th, 2019.

  Sign Up

Summary for PRETOMANID
Drug patent expirations by year for PRETOMANID
Drug Prices for PRETOMANID

See drug prices for PRETOMANID

Recent Clinical Trials for PRETOMANID

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

SponsorPhase
Global Alliance for TB Drug Development (TB Alliance)Phase 1
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Phase 1
National Institute of Mental Health (NIMH)Phase 1

See all PRETOMANID clinical trials

US Patents and Regulatory Information for PRETOMANID

PRETOMANID is protected by zero US patents and three FDA Regulatory Exclusivities.

FDA Regulatory Exclusivity protecting PRETOMANID

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Sign Up

INDICATED AS PART OF A COMBINATION REGIMEN WITH BEDAQUILINE AND LINEZOLID FOR THE TREATMENT OF ADULTS WITH PULMONARY EXTENSIVELY DRUG RESISTANT (XDR) OR TREATMENT-INTOLERANT OR NONRESPONSIVE MULTIDRUG-RESISTANT (MDR) TUBERCULOSIS (TB)
Exclusivity Expiration: ⤷  Sign Up

GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: ⤷  Sign Up

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mylan Ireland Ltd PRETOMANID pretomanid TABLET;ORAL 212862-001 Aug 14, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mylan Ireland Ltd PRETOMANID pretomanid TABLET;ORAL 212862-001 Aug 14, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 IRE Healthcare 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

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.