FEMTRACE Drug Patent Profile

Which patents cover Femtrace, and what generic alternatives are available?

Femtrace is a drug marketed by Apil and is included in one NDA. There is one patent protecting this drug.

This drug has eleven patent family members in ten countries.

The generic ingredient in FEMTRACE is estradiol acetate. There are seventy-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the estradiol acetate profile page.

DrugPatentWatch^® Generic Entry Outlook for Femtrace

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 2, 2025. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for FEMTRACE

International Patents:	11
US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	12
Patent Applications:	514
Formulation / Manufacturing:	see details
DailyMed Link:	FEMTRACE at DailyMed

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

NDA:

021633

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.

Anatomical Therapeutic Chemical (ATC) Classes for FEMTRACE

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 FEMTRACE

FEMTRACE is protected by one US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting FEMTRACE

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	021633-002	Aug 20, 2004		DISCN	Yes	No
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-003	Aug 20, 2004		DISCN	Yes	No

Expired US Patents for FEMTRACE

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	021633-002	Aug 20, 2004
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-001	Aug 20, 2004
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-002	Aug 20, 2004
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-003	Aug 20, 2004

International Patents for FEMTRACE

See the table below for patents covering FEMTRACE around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2005517673
New Zealand	532491	Oral pharmaceutical products containing 17beta-estradiol-3-lower alkanoate, method of administering the same and process of preparation
Norway	20042565
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)
China	1564689

Supplementary Protection Certificates for FEMTRACE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2782584	301153	Netherlands		PRODUCT NAME: COMPOSITION CONTAINING BOTH ESTRADIOL (17SS-ESTRADIOL), OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF (INCLUDING IN HEMIHYDRATE FORM), AND PROGESTERONE; NATIONAL REGISTRATION NO/DATE: RVG 125821 20210611; FIRST REGISTRATION: BE BE582231 20210406
0136011	99C0003	Belgium		PRODUCT NAME: ESTRADIOL AND NORETHISTERONE; FIRST REGISTRATION NO/DATE: 403 IS 106 F3 19980928; FIRST REGISTRATION: SE 14007 19980306
2782584	C202130068	Spain		PRODUCT NAME: COMPOSICION QUE CONTIENE ESTRADIOL (17BETA-ESTRADIOL), INCLUYENDO EN FORMA DE HEMIHIDRATO, Y PROGESTERONA; NATIONAL AUTHORISATION NUMBER: 85988-NL/H/4994/001/DC; DATE OF AUTHORISATION: 20210528; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): BE582231; DATE OF FIRST AUTHORISATION IN EEA: 20210406
0771217	07C0001	France		PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
1453521	300814	Netherlands		PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211