Menotropins
As of the edition of 20 October 2026, Menotropins is a protein: marketed, first approved in 1975 (US); acts on FSHR and LHCGR; US protection ended in 1987.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2020
- Kind
- Protein
- Brand name
- Pergonal
- First approved
- 22 August 1975 (US)
- Approvals on record
- 16 in 3 regions
- Holder of the most recent approval
- Boiron; 5 holders in all
- Registered trials
- 42, 1 stopped early
- Disease areas
- Urinary and reproductive; Pregnancy and women's health; Hormones; Cancer; Inherited and neonatal
US protection
US protection ended in 1987.
US protection ended in 1987, 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 Merck KGaA. 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.
Companies that need a new molecule because of this drug
2 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product2 company-target rows are on route B because of Menotropins.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 19 | 12 | 1 | 1 |
| Phase 3 | 6 | 4 | 1 | 0 |
| Phase 4 | 17 | 13 | 0 | 0 |
| All trials | 42 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Organon | Later holder and Lead sponsor of trials | 1994 to now |
| Ferring Pharmaceuticals | Later holder and Lead sponsor of trials | 1999 to now |
| Merck KGaA | Acquired holder and Lead sponsor of trials | 2003 to now |
| Boiron | Applicant | 2020 to now |