Omadacycline
As of the edition of 20 October 2026, Omadacycline is a small molecule: marketed, first approved in 2018 (US); US protection ends in 2030.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2018
- Kind
- Small molecule
- Brand name
- Nuzyra
- First approved
- 2 October 2018 (US)
- Approvals on record
- 2 in 1 region
- Holder of the most recent approval
- Transcept Pharmaceuticals
- Registered trials
- 22, 2 stopped early
- Disease areas
- Infections; Lungs and airways; Skin and connective tissue; Digestive system; Hormones; Inherited and neonatal
US protection
US protection ends in 2030.
The last listed US drug-substance patent ends in 2030. The application that gives this date is held by Transcept Pharmaceuticals.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product7 listings count towards this date. The exact date and each listing are in the product.
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Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 1 | 1 | 0 |
| Phase 1 | 6 | 5 | 1 | 0 |
| Phase 2 | 5 | 4 | 1 | 0 |
| Phase 3 | 7 | 4 | 0 | 2 |
| Phase 4 | 2 | 2 | 0 | 0 |
| All trials | 22 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Transcept Pharmaceuticals | Originator and Lead sponsor of trials | 2007 to now |