Follitropin beta
As of the edition of 20 October 2026, Follitropin beta is a protein: marketed, first approved in 1996 (EU); acts on FSHR; US protection ended in 2009.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1997
- Kind
- Protein
- Brand name
- Follistim
- First approved
- 2 May 1996 (EU)
- Approvals on record
- 9 in 2 regions
- Holder of the most recent approval
- Organon; 2 holders in all
- Registered trials
- 26, 5 stopped early
- Disease areas
- Urinary and reproductive; Inherited and neonatal; Pregnancy and women's health; Hormones
US protection
US protection ended in 2009.
US protection ended in 2009, 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 Organon. 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 product3 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 3 listings behind itRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| FSHR | Follicle-stimulating hormone receptor | P23945 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 12 | 10 | 0 | 1 |
| Phase 2 | 2 | 1 | 0 | 1 |
| Phase 3 | 3 | 2 | 0 | 1 |
| Phase 4 | 9 | 5 | 1 | 2 |
| All trials | 26 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Organon | Applicant and Lead sponsor of trials | 1996 to now |