PRETOMANID Drug Patent Profile
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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.
Summary for PRETOMANID
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 75 |
| Clinical Trials: | 17 |
| Patent Applications: | 95 |
| Drug Prices: | Drug price information for PRETOMANID |
| What excipients (inactive ingredients) are in PRETOMANID? | PRETOMANID excipients list |
| DailyMed Link: | PRETOMANID at DailyMed |
Recent Clinical Trials for PRETOMANID
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| 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 |
Anatomical Therapeutic Chemical (ATC) Classes for PRETOMANID
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: ⤷ Try a Trial
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: ⤷ Try a Trial
GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: ⤷ 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mylan Ireland Ltd | PRETOMANID | pretomanid | TABLET;ORAL | 212862-001 | Aug 14, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Mylan Ireland Ltd | PRETOMANID | pretomanid | TABLET;ORAL | 212862-001 | Aug 14, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Mylan Ireland Ltd | PRETOMANID | pretomanid | TABLET;ORAL | 212862-001 | Aug 14, 2019 | RX | Yes | Yes | ⤷ 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 |
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 |
