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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
McKesson
QuintilesIMS
Chinese Patent Office
Colorcon
Cerilliant
Julphar
Argus Health
Dow
Accenture

Generated: February 23, 2018

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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 estradiol acetate freedom to operate?

Estradiol acetate
is the generic ingredient in two branded drugs marketed by 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.
Pharmacology for estradiol acetate
Ingredient-typeEstradiol Congeners
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 021633-001 Aug 20, 2004 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Apil FEMTRACE estradiol acetate TABLET;ORAL 021633-001 Aug 20, 2004 DISCN Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Apil FEMTRACE estradiol acetate TABLET;ORAL 021633-002 Aug 20, 2004 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Apil FEMRING estradiol acetate INSERT, EXTENDED RELEASE;VAGINAL 021367-001 Mar 20, 2003 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Apil FEMTRACE estradiol acetate TABLET;ORAL 021633-003 Aug 20, 2004 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Apil FEMTRACE estradiol acetate TABLET;ORAL 021633-001 Aug 20, 2004 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Apil FEMTRACE estradiol acetate TABLET;ORAL 021633-002 Aug 20, 2004 DISCN Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Apil FEMTRACE estradiol acetate TABLET;ORAL 021633-003 Aug 20, 2004 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Apil FEMRING estradiol acetate INSERT, EXTENDED RELEASE;VAGINAL 021367-002 Mar 20, 2003 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Apil FEMTRACE estradiol acetate TABLET;ORAL 021633-003 Aug 20, 2004 DISCN Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for estradiol acetate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil FEMRING estradiol acetate INSERT, EXTENDED RELEASE;VAGINAL 021367-001 Mar 20, 2003 ➤ Sign Up ➤ Sign Up
Apil FEMRING estradiol acetate INSERT, EXTENDED RELEASE;VAGINAL 021367-002 Mar 20, 2003 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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International Patents for estradiol acetate

Supplementary Protection Certificates for estradiol acetate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB04/032 United Kingdom ➤ Sign Up PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310
C0001 France ➤ Sign Up PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
2009 Austria ➤ Sign Up PRODUCT NAME: KOMBINATION AUS ESTRADIOLVALERAT UND DIENOGEST; NAT. REGISTRATION NO/DATE: 1-28003 20090203; FIRST REGISTRATION: BE BE 327792 20081103
C0005 Belgium ➤ Sign Up PRODUCT NAME: ESTRADIOL HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: 298 IS 190 F 15 19960806; FIRST REGISTRATION: GB PL/0053/0241 19950711
2016 00016 Denmark ➤ Sign Up PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
09/012 Ireland ➤ Sign Up PRODUCT NAME: QLAIRA-ESTRADIOL VALERATE/DIENOGEST; NAT REGISTRATION NO/DATE: PA1410/58/1 20090109; FIRST REGISTRATION NO/DATE: BE327792 20081103
C0003 Belgium ➤ Sign Up PRODUCT NAME: ESTRADIOL AND NORETHISTERONE; FIRST REGISTRATION NO/DATE: 403 IS 106 F3 19980928; FIRST REGISTRATION: SE 14007 19980306
C0002 Belgium ➤ Sign Up PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
2006 00038 Denmark ➤ Sign Up PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
0136011/03 Switzerland ➤ Sign Up PRODUCT NMAE: ESTRADIOL UND MEDROXYPROGESTERONACETAT; REGISTRATION NO/DATE: IKS 55288 20000417
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Julphar
Citi
Baxter
Chubb
Colorcon
Healthtrust
Harvard Business School
Boehringer Ingelheim

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