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Last Updated: May 13, 2021

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ESTRADIOL ACETATE - Generic Drug Details

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What are the generic drug 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 are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Estradiol acetate has eleven patent family members in ten countries.

There are seventy-five drug master file entries for estradiol acetate.

Summary for ESTRADIOL ACETATE
International Patents:11
US Patents:3
Tradenames:2
Applicants:2
NDAs:2
Drug Master File Entries: 75
Raw Ingredient (Bulk) Api Vendors: 3
Clinical Trials: 106
Patent Applications: 941
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in ESTRADIOL ACETATE?ESTRADIOL ACETATE excipients list
DailyMed Link:ESTRADIOL ACETATE at DailyMed
Recent Clinical Trials for ESTRADIOL ACETATE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Johns Hopkins UniversityPhase 1
Myovant Sciences GmbHPhase 1
Merck Sharp & Dohme Corp.Early Phase 1

See all ESTRADIOL ACETATE clinical trials

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
Apil FEMTRACE estradiol acetate TABLET;ORAL 021633-001 Aug 20, 2004 DISCN Yes No   Get Started for $10   Get Started for $10   Get Started for $10
Apil FEMTRACE estradiol acetate TABLET;ORAL 021633-001 Aug 20, 2004 DISCN Yes No   Get Started for $10   Get Started for $10 Y   Get Started for $10
Apil FEMTRACE estradiol acetate TABLET;ORAL 021633-003 Aug 20, 2004 DISCN Yes No   Get Started for $10   Get Started for $10 Y   Get Started for $10
Millicent FEMRING estradiol acetate INSERT, EXTENDED RELEASE;VAGINAL 021367-001 Mar 20, 2003 RX Yes No   Get Started for $10   Get Started for $10   Get Started for $10
Apil FEMTRACE estradiol acetate TABLET;ORAL 021633-003 Aug 20, 2004 DISCN Yes No   Get Started for $10   Get Started for $10   Get Started for $10
Apil FEMTRACE estradiol acetate TABLET;ORAL 021633-001 Aug 20, 2004 DISCN Yes No   Get Started for $10   Get Started for $10 Y   Get Started for $10
>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   Get Started for $10   Get Started for $10
Millicent FEMRING estradiol acetate INSERT, EXTENDED RELEASE;VAGINAL 021367-002 Mar 20, 2003   Get Started for $10   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ESTRADIOL ACETATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0136011 99C0003 Belgium   Get Started for $10 PRODUCT NAME: ESTRADIOL AND NORETHISTERONE; FIRST REGISTRATION NO/DATE: 403 IS 106 F3 19980928; FIRST REGISTRATION: SE 14007 19980306
0584952 99C0004 Belgium   Get Started for $10 PRODUCT NAME: ESTRADIOL, HEMIHYDRATE, NORETHISTERONE, ACETATE; NAT. REGISTRATION NO/DATE: NL 23753 19981210; FIRST REGISTRATION: SE - 14 007 19980306
1380301 CA 2009 00017 Denmark   Get Started for $10 PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
1453521 300814 Netherlands   Get Started for $10 PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
0136011 C00136011/03 Switzerland   Get Started for $10 PRODUCT NMAE: ESTRADIOL UND MEDROXYPROGESTERONACETAT; REGISTRATION NO/DATE: IKS 55288 20000417
0285237 95C0008 Belgium   Get Started for $10 PRODUCT NAME: ESTRADIOL, HEMIHYDRATE; NAT. REGISTRATION NO/DATE: NL 19489 19941107; FIRST REGISTRATION: FR - NL 19489 19941107
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
McKesson
Medtronic
Baxter
Boehringer Ingelheim
Merck

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