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
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
Generic Entry Date for FEMTRACE*:
Constraining patent/regulatory exclusivity:
NDA:
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
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 ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Apil | FEMTRACE | estradiol acetate | TABLET;ORAL | 021633-002 | Aug 20, 2004 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Apil | FEMTRACE | estradiol acetate | TABLET;ORAL | 021633-003 | Aug 20, 2004 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Apil | FEMTRACE | estradiol acetate | TABLET;ORAL | 021633-002 | Aug 20, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
Apil | FEMTRACE | estradiol acetate | TABLET;ORAL | 021633-002 | Aug 20, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
Apil | FEMTRACE | estradiol acetate | TABLET;ORAL | 021633-001 | Aug 20, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
Apil | FEMTRACE | estradiol acetate | TABLET;ORAL | 021633-003 | Aug 20, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
Apil | FEMTRACE | estradiol acetate | TABLET;ORAL | 021633-003 | Aug 20, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
>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.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 1564689 | ⤷ Try a Trial | |
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) | ⤷ Try a Trial |
Japan | 2005517673 | ⤷ Try a Trial | |
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) | ⤷ Try a Trial |
China | 1273141 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for FEMTRACE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0136011 | 99C0003 | Belgium | ⤷ Try a Trial | 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 | ⤷ Try a Trial | 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 | ⤷ Try a Trial | 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 | ⤷ Try a Trial | PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811 |
2782584 | 122021000080 | Germany | ⤷ Try a Trial | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |