Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 15, 2019

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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. Two suppliers are listed for this compound.

Summary for ESTRADIOL ACETATE
Recent Clinical Trials for ESTRADIOL ACETATE

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

SponsorPhase
ObsEva SAPhase 3
Centre Hospitalier Intercommunal CreteilPhase 3
University of VirginiaN/A

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
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 021633-002 Aug 20, 2004 DISCN Yes No   Start Trial   Start Trial   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 021633-003 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 Y   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
0770388 PA2009004 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
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
1453521 93156 Luxembourg   Start Trial PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
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
1214076 SZ 49/2008 Austria   Start Trial PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
0334429 97C0002 Belgium   Start Trial PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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