Drug

Estradiol acetate

As of the edition of 20 October 2026, Estradiol acetate is a small molecule: marketed, first approved in 2003 (US); acts on ESR1; no US protection is listed.

Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.

The drug

Status
Marketed; latest approval 2003
Kind
Small molecule
Brand name
Femring
First approved
20 March 2003 (US)
Approvals on record
5 in 1 region
Holder of the most recent approval
AbbVie; 2 holders in all
Registered trials
2, 0 stopped early
Disease areas
Pregnancy and women's health; Urinary and reproductive

US protection

No US protection is listed.

The FDA registers list no drug-substance patent or exclusivity that counts for this 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 product

1 company is on route B because of Estradiol acetate.

Target

GeneProteinUniProt
ESR1Estrogen receptorP03372

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated1100
Phase 31100
All trials2

Who has held its approvals

CompanyRoleYears
Warner ChilcottLater holder and Lead sponsor of trials2003 to now
AbbVieAcquired holder2016 to now
Millicent Manufacturing PrAcquired holder2026 to now
GalenOriginator2003 to 2026