Ethinyl estradiol
As of the edition of 20 October 2026, Ethinyl estradiol is a small molecule: marketed, first approved in 1975 (ES); acts on ESR1; 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 2008
- Kind
- Small molecule
- Brand name
- Norminest Fe
- First approved
- 1 April 1975 (ES)
- Approvals on record
- 130 in 7 regions
- Holder of the most recent approval
- Viatris; 29 holders in all
- Registered trials
- 215, 21 stopped early
- Disease areas
- Urinary and reproductive; Pregnancy and women's health; Hormones; Infections; Cancer; Nutrition and metabolism
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.
Viatris holds a later exclusivity on its own new formulation or combination product, ending 2029; it does not protect the original drug.
This is the US only.
Companies that need a new molecule because of this drug
5 companies on route B because of this drug.
Companies on route B for this drug
In the product5 companies are on route B because of Ethinyl estradiol.
See the 5 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| ESR1 | Estrogen receptor | P03372 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 34 | 23 | 2 | 3 |
| Phase 1 | 91 | 75 | 3 | 9 |
| Phase 2 | 23 | 17 | 1 | 4 |
| Phase 3 | 34 | 27 | 1 | 2 |
| Phase 4 | 33 | 23 | 2 | 3 |
| All trials | 215 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Applicant, Later holder and Lead sponsor of trials | 1976 to now |
| Labatec Pharma | Applicant | 1983 to now |
| Bayer | Later holder and Lead sponsor of trials | 1987 to now |
| Organon | Acquired holder, Later holder and Lead sponsor of trials | 2000 to now |
| Gedeon Richter | Applicant | 2002 to now |
| Nobelpharma | Applicant and Lead sponsor of trials | 2004 to now |
| AbbVie | Later holder and Lead sponsor of trials | 2013 to now |
| Merck & Co. | Applicant and Lead sponsor of trials | 2023 to now |