Hyaluronidase
As of the edition of 20 October 2026, Hyaluronidase is an enzyme: marketed, first approved in 1982 (US); no US protection of its own is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2022
- Kind
- Enzyme
- Brand name
- Wydase
- First approved
- 1 January 1982 (US)
- Approvals on record
- 31 in 3 regions
- Holder of the most recent approval
- Johnson & Johnson; 10 holders in all
- Registered trials
- 42, 4 stopped early
- Disease areas
- Cancer; Immune system; Blood and lymph; Heart and blood vessels; Inherited and neonatal; Nutrition and metabolism
US protection
No US protection of its own is listed.
The FDA registers list no drug-substance patent or exclusivity of its own that counts for this drug.
argenx holds a later exclusivity on its own new formulation or combination product, ending 2031; it does not protect the original drug.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 8 | 4 | 1 | 1 |
| Phase 1 | 11 | 6 | 4 | 1 |
| Phase 2 | 13 | 1 | 9 | 2 |
| Phase 3 | 8 | 3 | 4 | 0 |
| Phase 4 | 2 | 2 | 0 | 0 |
| All trials | 42 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Amphastar Pharmaceuticals | Later holder and Lead sponsor of trials | 2004 to now |
| Akorn | Acquired holder | 2011 to now |
| Takeda | Applicant and Lead sponsor of trials | 2011 to now |
| Bausch Health | Acquired holder | 2020 to now |
| Johnson & Johnson | Applicant | 2021 to now |
| Baxter Healthcare | Applicant |