Estradiol
As of the edition of 20 October 2026, Estradiol is a small molecule: marketed, first approved in 1969 (ES); acts on ESR1; US protection ends in 2032.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2022
- Kind
- Small molecule
- Brand name
- Delestrogen
- First approved
- 1 April 1969 (ES)
- Approvals on record
- 101 in 8 regions
- Holder of the most recent approval
- ORGANON FARMACĂUTICA LTDA.; 32 holders in all
- Withdrawn from market
- 31 July 2014 (in some regions)
- Registered trials
- 247, 37 stopped early
- Disease areas
- Urinary and reproductive; Pregnancy and women's health; Mental health; Cancer; Hormones; Heart and blood vessels
US protection
US protection ends in 2032.
The last listed US drug-substance patent ends in 2032.
Sumitomo Pharma holds a later exclusivity on its own new formulation or combination product, ending 2033; it does not protect the original drug.
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 product2 listings count towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
6 companies on route B because of this drug.
Companies on route B for this drug
In the product6 companies are on route B because of Estradiol.
See the 6 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 | 44 | 23 | 9 | 5 |
| Phase 1 | 32 | 20 | 4 | 6 |
| Phase 2 | 50 | 24 | 7 | 14 |
| Phase 3 | 69 | 55 | 2 | 7 |
| Phase 4 | 52 | 28 | 13 | 5 |
| All trials | 247 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Novo Nordisk | Applicant and Lead sponsor of trials | 1977 to now |
| Novartis | Later holder | 1986 to now |
| CSL Behring | Later holder | 1986 to now |
| Noven Therapeutics | Later holder | 1994 to now |
| Pfizer | Applicant, Acquired holder, Later holder and Lead sponsor of trials | 1995 to now |
| Procter And Gamble | Later holder | 1996 to now |
| Bayer | Acquired holder, Later holder and Lead sponsor of trials | 1997 to now |
| Actavis | Later holder and Lead sponsor of trials | 2002 to now |
| Galen | Later holder | 2003 to now |
| Johnson & Johnson | Acquired holder | 2003 to now |
| Women First Healthcare | Acquired holder | 2003 to now |
| ANI Pharmaceuticals | Later holder and Lead sponsor of trials | 2003 to now |
| Novavax | Later holder | 2003 to now |
| Solvay Pharmaceuticals | Later holder and Lead sponsor of trials | 2004 to now |
| Upsher-Smith | Later holder and Lead sponsor of trials | 2004 to now |
| Warner Chilcott | Later holder and Lead sponsor of trials | 2004 to now |
| Ascend Therapeutics | Acquired holder and Lead sponsor of trials | 2004 to now |
| Kv Pharmaceutical | Later holder | 2007 to now |
| ASKA Pharmaceutical | Applicant | 2008 to now |
| Theramex | Applicant | 2011 to now |
| AbbVie | Acquired holder and Lead sponsor of trials | 2011 to now |
| TherapeuticsMD | Later holder and Lead sponsor of trials | 2013 to now |
| Viatris | Acquired holder and Lead sponsor of trials | 2014 to now |
| Vertical Pharmaceuticals | Acquired holder | 2014 to now |
| Padagis | Acquired holder and Lead sponsor of trials | 2016 to now |
| Exeltis | Acquired holder | 2016 to now |
| Gedeon Richter | Later holder | 2021 to now |
| Sandoz | Acquired holder | 2023 to now |
| Ph Health | Acquired holder | 2025 to now |
| Millicent Manufacturing Pr | Acquired holder | 2026 to now |
| Bristol Myers Squibb | Applicant | |
| Hisamitsu Pharmaceutical | Later holder |