ESTRADIOL ACETATE - Generic Drug Details

What are the generic sources for estradiol acetate and what is the scope of freedom to operate?

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

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
Millicent	FEMRING	estradiol acetate	INSERT, EXTENDED RELEASE;VAGINAL	021367-001	Mar 20, 2003		RX	Yes	No
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-001	Aug 20, 2004		DISCN	Yes	No
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-002	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

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
New Zealand	532491	Oral pharmaceutical products containing 17beta-estradiol-3-lower alkanoate, method of administering the same and process of preparation
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)
Japan	2005517673
Mexico	PA04006057	PRODUCTOS FARMACEUTICOS ORALES QUE CONTIENEN 3-ALCANOATO INFERIOR DE 17-BETA-ESTRADIOL, METODO PARA ADMINISTRAR LOS MISMOS Y PROCESO DE PREPARACION. (ORAL PHARMACEUTICAL PRODUCTS CONTAINING 17beta-ESTRADIOL-3-LOWER ALKANOATE, METHOD OF ADMINISTERING THE SAME AND PROCESS OF PREPARATION.)
Australia	2002359758
China	1273141
European Patent Office	1461043

Supplementary Protection Certificates for ESTRADIOL ACETATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
1453521	C 2015 029	Romania		PRODUCT NAME: LEVONORGESTREL SI ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: RO 7793/2015/001; DATE OF NATIONAL AUTHORISATION: 20150612; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): SK. 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150129
0398460	12/2004	Austria		PRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211
0398460	C300221	Netherlands		PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
0402407	97C0005	Belgium		PRODUCT NAME: ESTRADIOL HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: 298 IS 190 F 15 19960806; FIRST REGISTRATION: GB PL/0053/0241 19950711
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
0285237	95C0008	Belgium		PRODUCT NAME: ESTRADIOL, HEMIHYDRATE; NAT. REGISTRATION NO/DATE: NL 19489 19941107; FIRST REGISTRATION: FR - NL 19489 19941107