Hyaluronidase (human recombinant)
As of the edition of 20 October 2026, Hyaluronidase (human recombinant) is an enzyme: marketed, first approved in 2005 (US); US protection ended in 2017.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2022
- Kind
- Enzyme
- Brand name
- Hylenex Recombinant
- First approved
- 2 December 2005 (US)
- Approvals on record
- 23 in 3 regions
- Holder of the most recent approval
- Johnson & Johnson; 8 holders in all
- Registered trials
- 113, 12 stopped early
- Disease areas
- Cancer; Immune system; Blood and lymph; Nutrition and metabolism; Skin and connective tissue; Heart and blood vessels
US protection
US protection ended in 2017.
US protection ended in 2017, computed as 12 years from the first US licence because FDA publishes no date for this product. The date is computed, not published.
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, 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 | 7 | 1 | 2 | 0 |
| Phase 1 | 40 | 27 | 7 | 6 |
| Phase 2 | 34 | 15 | 14 | 5 |
| Phase 3 | 24 | 8 | 16 | 0 |
| Phase 4 | 8 | 7 | 0 | 1 |
| All trials | 113 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Halozyme Therapeutics | Applicant and Lead sponsor of trials | 2005 to now |
| Takeda | Applicant and Lead sponsor of trials | 2008 to now |
| Johnson & Johnson | Applicant and Lead sponsor of trials | 2015 to now |
| Roche | Later holder and Lead sponsor of trials | 2018 to now |