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Last Updated: April 20, 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 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
International Patents:11
US Patents:3
Tradenames:2
Applicants:2
NDAs:2
Drug Master File Entries: 75
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 021633-003 Aug 20, 2004 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Apil FEMTRACE estradiol acetate TABLET;ORAL 021633-001 Aug 20, 2004 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Millicent FEMRING estradiol acetate INSERT, EXTENDED RELEASE;VAGINAL 021367-001 Mar 20, 2003 RX 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 021633-003 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 Y   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
1380301 CA 2009 00017 Denmark   Start Trial PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
1453521 15C0050 France   Start Trial PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
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
1453521 C201630040 Spain   Start Trial PRODUCT NAME: ETINILESTRADIOL Y MEZCLA DE LEVONORGESTREL Y ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: 80340; DATE OF AUTHORISATION: 20160122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150211
0398460 12/2004 Austria   Start Trial PRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211
1453521 93156 Luxembourg   Start Trial PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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