FEMTRACE Drug Patent Profile

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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

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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

Drug patent expirations by year for FEMTRACE

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

Generic Entry Date for FEMTRACE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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.

US Patents and Regulatory Information for FEMTRACE

FEMTRACE is protected by one US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of FEMTRACE is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
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

Oral pharmaceutical products containing 17.beta.-estradiol-3-lower alkanoate, method of administering the same and process of preparation
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-002	Aug 20, 2004		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-003	Aug 20, 2004		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for FEMTRACE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-003	Aug 20, 2004	⤷ Sign Up	⤷ Sign Up
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-003	Aug 20, 2004	⤷ Sign Up	⤷ Sign Up
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-001	Aug 20, 2004	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for FEMTRACE

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

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Country	Patent Number	Title	Estimated Expiration
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)	⤷ Sign Up
Norway	20042565		⤷ Sign Up
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)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for FEMTRACE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0136011	2000C/027	Belgium	⤷ Sign Up	PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
1453521	C 2015 029	Romania	⤷ Sign Up	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
1453521	132016000025143	Italy	⤷ Sign Up	PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description