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Last Updated: September 21, 2021

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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
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: 108
Patent Applications: 954
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
University of UtahEarly 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 ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Apil FEMTRACE estradiol acetate TABLET;ORAL 021633-003 Aug 20, 2004 DISCN Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Apil FEMTRACE estradiol acetate TABLET;ORAL 021633-003 Aug 20, 2004 DISCN Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Apil FEMTRACE estradiol acetate TABLET;ORAL 021633-003 Aug 20, 2004 DISCN Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Millicent FEMRING estradiol acetate INSERT, EXTENDED RELEASE;VAGINAL 021367-002 Mar 20, 2003 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 ⤷  Try it Free ⤷  Try it Free
Millicent FEMRING estradiol acetate INSERT, EXTENDED RELEASE;VAGINAL 021367-002 Mar 20, 2003 ⤷  Try it Free ⤷  Try it Free
>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 9/2009 Austria ⤷  Try it Free PRODUCT NAME: KOMBINATION AUS ESTRADIOLVALERAT UND DIENOGEST; NAT. REGISTRATION NO/DATE: 1-28003 20090203; FIRST REGISTRATION: BE BE 327792 20081103
0584952 99C0004 Belgium ⤷  Try it Free PRODUCT NAME: ESTRADIOL, HEMIHYDRATE, NORETHISTERONE, ACETATE; NAT. REGISTRATION NO/DATE: NL 23753 19981210; FIRST REGISTRATION: SE - 14 007 19980306
1453521 300814 Netherlands ⤷  Try it Free PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
0770388 PA2009004,C0770388 Lithuania ⤷  Try it Free 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
1380301 CA 2009 00017 Denmark ⤷  Try it Free PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
Colorcon
Medtronic
AstraZeneca
Merck
Express Scripts

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