Estradiol acetate - Generic Drug Details

What are the generic drug sources for estradiol acetate and what is the scope of patent protection?

Estradiol acetate is the generic ingredient in two branded drugs marketed by Millicent and Apil, and is included in two NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Estradiol acetate has eleven patent family members in ten countries.

One supplier is listed for this compound.

Summary for estradiol acetate

International Patents:	11
US Patents:	1
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	13
Clinical Trials:	119
Patent Applications:	893
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in estradiol acetate?	estradiol acetate excipients list
DailyMed Link:	estradiol acetate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for estradiol acetate

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for estradiol acetate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Bio Genuine (Shanghai) Biotech Co., Ltd.	Phase 3
University of Chicago	Phase 4
Myovant Sciences GmbH	Phase 4

See all estradiol acetate clinical trials

Pharmacology for estradiol acetate

Drug Class	Estrogen
Mechanism of Action	Estrogen Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for estradiol acetate

G03CA	Natural and semisynthetic estrogens, plain
G03C	ESTROGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for estradiol acetate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-001	Aug 20, 2004		DISCN	Yes	No
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-003	Aug 20, 2004		DISCN	Yes	No
Millicent	FEMRING	estradiol acetate	INSERT, EXTENDED RELEASE;VAGINAL	021367-002	Mar 20, 2003		RX	Yes	Yes
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-002	Aug 20, 2004		DISCN	Yes	No
Millicent	FEMRING	estradiol acetate	INSERT, EXTENDED RELEASE;VAGINAL	021367-001	Mar 20, 2003		RX	Yes	No

Expired US Patents for estradiol acetate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-003	Aug 20, 2004
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-001	Aug 20, 2004
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-001	Aug 20, 2004
Millicent	FEMRING	estradiol acetate	INSERT, EXTENDED RELEASE;VAGINAL	021367-001	Mar 20, 2003
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-003	Aug 20, 2004
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-002	Aug 20, 2004
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-002	Aug 20, 2004

International Patents for estradiol acetate

Country	Patent Number	Title	Estimated Expiration
China	1564689
Canada	2470703	PRODUITS PHARMACEUTIQUES ORAUX RENFERMANT 17.BETA.-ESTRADIOL-3-ALCANOATE INFERIEUR, PROCEDE D'ADMINISTRATION ET DE PREPARATION ASSOCIES (ORAL PHARMACEUTICAL PRODUCTS CONTAINING 17.BETA.-ESTRADIOL-3-LOWER ALKANOATE, METHOD OF ADMINISTERING THE SAME AND PROCESS OF PREPARATION)
Japan	2005517673
Israel	160797	תכשירי רוקחות לצריכה דרך הפה המכילים ב-17-אסטרדיול-3-אצטאט, שיטה להכנתם ושימוש ב-ב-17-אסטרדיול-3-אצטאט להכנתם (Oral pharmaceutical products containing 17beta-estradiol-3-acetate, process of preparation of the same and use of 17-beta-estradiol-3-acetate in the preparation of the same)
China	1273141
Australia	2002359758
World Intellectual Property Organization (WIPO)	03055495

Supplementary Protection Certificates for estradiol acetate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0136011	99C0003	Belgium		PRODUCT NAME: ESTRADIOL AND NORETHISTERONE; FIRST REGISTRATION NO/DATE: 403 IS 106 F3 19980928; FIRST REGISTRATION: SE 14007 19980306
0398460	SPC/GB04/032	United Kingdom		PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310
0770388	SPC/GB09/026	United Kingdom		PRODUCT NAME: ESTRADIOL AND COMBINATIONS OF ESTRADIOL AND DIENOGEST, PREFERABLY ESTRADIOL VALERATE AND COMBINATIONS OF ESTRADIOL VALERATE AND DIENOGEST; REGISTERED: BE BE 327792 20081103; UK PL 00010/0576-0001 20081208
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
2782584	122021000080	Germany		PRODUCT NAME: ZUSAMMENSETZUNG, DIE SOWOHL ESTRADIOL (17SS-ESTRADIOL), GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, HYDRATS ODER SOLVATS DAVON (EINSCHLIESSLICH IN FORM EINES HEMIHYDRATS), ALS AUCH PROGESTERON ENTHAELT; NAT. REGISTRATION NO/DATE: 2205034.00.00 20210924; FIRST REGISTRATION: BELGIEN BE582231 20210406
0771217	07C0001	France		PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
1453521	C201630040	Spain		PRODUCT NAME: ETINILESTRADIOL Y MEZCLA DE LEVONORGESTREL Y ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: 80340; DATE OF AUTHORISATION: 20160122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150211