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Last Updated: November 24, 2024

Estradiol acetate - Generic Drug Details


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What are the generic 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
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
Generic Entry Date for estradiol acetate*:
Constraining patent/regulatory exclusivity:
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

SponsorPhase
Bio Genuine (Shanghai) Biotech Co., Ltd.Phase 3
University of ChicagoPhase 4
Myovant Sciences GmbHPhase 4

See all estradiol acetate clinical trials

Pharmacology for estradiol acetate
Drug ClassEstrogen
Mechanism of ActionEstrogen 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 ⤷  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
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
>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 estradiol acetate

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

International Patents for estradiol acetate

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 03055495 ⤷  Sign Up
New Zealand 532491 Oral pharmaceutical products containing 17beta-estradiol-3-lower alkanoate, method of administering the same and process of preparation ⤷  Sign Up
Australia 2002359758 ⤷  Sign Up
Norway 20042565 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for estradiol acetate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
0770388 PA2009004 Lithuania ⤷  Sign Up PRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103
1453521 CA 2016 00016 Denmark ⤷  Sign Up PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
2782584 21C1058 France ⤷  Sign Up PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17SS-ESTRADIOL), Y COMPRIS SOUS FORME HEMIHYDRATEE, ET DE LA PROGESTERONE; NAT. REGISTRATION NO/DATE: NL51886 20210421; FIRST REGISTRATION: BE - BE582231 20210406
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.