Hyaluronidase (ovine)
As of the edition of 20 October 2026, Hyaluronidase (ovine) is an enzyme: marketed, first approved in 2004 (US); US protection ended in 2016.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2004
- Kind
- Enzyme
- Brand name
- Vitrase
- First approved
- 5 May 2004 (US)
- Approvals on record
- 2 in 1 region
- Holder of the most recent approval
- Bausch Health
- Registered trials
- 7, 0 stopped early
- Disease areas
- Eye; Heart and blood vessels; Hormones; Chemically induced
US protection
US protection ended in 2016.
US protection ended in 2016, 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 Bausch Health. 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 product1 listing counts towards this date. The exact date and each listing are in the product.
See the exact date and the 1 listing behind itRequest access. Nothing is shown until you do.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 2 | 2 | 0 | 0 |
| Phase 2 | 1 | 1 | 0 | 0 |
| Phase 3 | 3 | 3 | 0 | 0 |
| Phase 4 | 1 | 1 | 0 | 0 |
| All trials | 7 |
Who ran its trials
| Company | Role | Years |
|---|---|---|
| Bausch Health | Lead sponsor of trials | 1998 to now |