Urofollitropin
As of the edition of 20 October 2026, Urofollitropin is a drug: marketed, first approved in 1986 (US); acts on FSHR; 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 2024
- Kind
- Unknown
- Brand name
- Metrodin
- First approved
- 18 September 1986 (US)
- Approvals on record
- 11 in 5 regions
- Holder of the most recent approval
- BESINS HEALTHCARE BRASIL COMERCIAL E DISTRIBUIDORA DE MEDICAMEN; 6 holders in all
- Registered trials
- 12, 2 stopped early
- Disease areas
- Urinary and reproductive; Pregnancy and women's health; Hormones; Cancer
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.
Ferring Pharmaceuticals holds a later exclusivity on its own new formulation or combination product, which ended in 2014; it does not protect the original drug.
This is the US only.
Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Urofollitropin.
See the 1 company on route B for this drug, with the facts behind eachRequest 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 | 2 | 0 | 0 | 1 |
| Phase 2 | 2 | 0 | 0 | 0 |
| Phase 3 | 5 | 3 | 0 | 1 |
| Phase 4 | 3 | 2 | 0 | 0 |
| All trials | 12 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| IBSA Institut Biochimique | Applicant and Lead sponsor of trials | 1996 to now |
| Ferring Pharmaceuticals | Applicant and Lead sponsor of trials | 2002 to now |