Antihemophilic factor, pegylated (mw 20000) human sequence recombinant
As of the edition of 20 October 2026, Antihemophilic factor, pegylated (mw 20000) human sequence recombinant is a drug: marketed, first approved in 2015 (US); US protection ends in 2027.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2018
- Kind
- Unknown
- Brand name
- Adynovate
- First approved
- 13 November 2015 (US)
- Approvals on record
- 11 in 3 regions
- Holder of the most recent approval
- Takeda; 4 holders in all
- Registered trials
- 17, 0 stopped early
- Disease areas
- Blood and lymph; Inherited and neonatal; Bones, joints and muscles; Heart and blood vessels
US protection
US protection ends in 2027.
US protection ends in 2027, 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 Takeda. 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 not stated | 7 | 6 | 1 | 0 |
| Phase 1 | 3 | 3 | 0 | 0 |
| Phase 3 | 7 | 7 | 0 | 0 |
| All trials | 17 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Takeda | Applicant, Later holder and Lead sponsor of trials | 2011 to now |
| Baxter Healthcare | Applicant | 2016 to now |