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Last Updated: December 1, 2020

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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 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
Recent Clinical Trials for estradiol acetate

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

SponsorPhase
University of UtahEarly Phase 1
Merck Sharp & Dohme Corp.Early Phase 1
TherapeuticsMDPhase 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   Start Trial   Start Trial Y   Start Trial
Apil FEMTRACE estradiol acetate TABLET;ORAL 021633-003 Aug 20, 2004 DISCN Yes No   Start Trial   Start Trial   Start Trial
Apil FEMTRACE estradiol acetate TABLET;ORAL 021633-001 Aug 20, 2004 DISCN Yes No   Start Trial   Start Trial   Start Trial
Apil FEMTRACE estradiol acetate TABLET;ORAL 021633-002 Aug 20, 2004 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Apil FEMTRACE estradiol acetate TABLET;ORAL 021633-003 Aug 20, 2004 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Apil FEMTRACE estradiol acetate TABLET;ORAL 021633-002 Aug 20, 2004 DISCN Yes No   Start Trial   Start Trial   Start 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 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   Start Trial   Start Trial
Millicent FEMRING estradiol acetate INSERT, EXTENDED RELEASE;VAGINAL 021367-002 Mar 20, 2003   Start Trial   Start Trial
>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
1453521 122015000093 Germany   Start Trial PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
0770388 SPC/GB09/026 United Kingdom   Start 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
0770388 PA2009004,C0770388 Lithuania   Start Trial 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
0584952 99C0004 Belgium   Start Trial PRODUCT NAME: ESTRADIOL, HEMIHYDRATE, NORETHISTERONE, ACETATE; NAT. REGISTRATION NO/DATE: NL 23753 19981210; FIRST REGISTRATION: SE - 14 007 19980306
1453521 CA 2016 00016 Denmark   Start Trial PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
0285237 95C0008 Belgium   Start Trial 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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