Pretomanid - Generic Drug Details
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What are the generic sources for pretomanid and what is the scope of freedom to operate?
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
| US Patents: | 0 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 75 |
| Clinical Trials: | 21 |
| Patent Applications: | 151 |
| Drug Prices: | Drug price trends 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 |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | Phase 2 |
| GlaxoSmithKline | Phase 2 |
| Lygature | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for pretomanid
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 | ⤷ 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 |
