Dornase alfa
As of the edition of 20 October 2026, Dornase alfa is an enzyme: marketed, first approved in 1993 (US); US protection ended in 2005.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2012
- Kind
- Enzyme
- Brand name
- Pulmozyme
- First approved
- 30 December 1993 (US)
- Approvals on record
- 4 in 4 regions
- Holder of the most recent approval
- Roche; 4 holders in all
- Registered trials
- 29, 4 stopped early
- Disease areas
- Lungs and airways; Infections; Digestive system; Inherited and neonatal; Heart and blood vessels; Nervous system
US protection
US protection ended in 2005.
US protection ended in 2005, computed as 12 years from the first US licence because FDA publishes no date for this product. The application that gives this date is held by Roche. The date is computed, not published.
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 product2 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 | 1 | 1 | 0 | 0 |
| Phase 1 | 3 | 1 | 1 | 0 |
| Phase 2 | 12 | 7 | 3 | 0 |
| Phase 3 | 8 | 4 | 1 | 1 |
| Phase 4 | 5 | 2 | 0 | 3 |
| All trials | 29 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Roche | Applicant and Lead sponsor of trials | 1993 to now |