Posaconazole
As of the edition of 20 October 2026, Posaconazole is a small molecule: marketed, first approved in 2005 (EU); US protection ends in 2029.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2020
- Kind
- Small molecule
- Brand name
- Noxafil
- First approved
- 25 October 2005 (EU)
- Approvals on record
- 18 in 8 regions
- Holder of the most recent approval
- Merck & Co.; 4 holders in all
- Withdrawn from market
- 20 November 2008 (in some regions)
- Registered trials
- 75, 10 stopped early
- Disease areas
- Infections; Blood and lymph; Cancer; Immune system; Lungs and airways; Inherited and neonatal
US protection
US protection ends in 2029.
The last listed US exclusivity ends in 2029. The application that gives this date is held by Merck & Co..
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
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Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 13 | 7 | 3 | 0 |
| Phase 1 | 17 | 10 | 3 | 4 |
| Phase 2 | 20 | 12 | 6 | 2 |
| Phase 3 | 14 | 11 | 2 | 0 |
| Phase 4 | 11 | 7 | 0 | 4 |
| All trials | 75 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Merck & Co. | Applicant and Lead sponsor of trials | 1998 to now |