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Generated: September 23, 2017

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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. Three suppliers are listed for this compound.

Summary for Generic Name: estradiol acetate

Tradenames:2
Patents:3
Applicants:1
NDAs:2
Drug Master File Entries: see list75
Suppliers / Packagers: see list3
Bulk Api Vendors: see list5
Clinical Trials: see list1,512
Patent Applications: see list366
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:estradiol acetate at DailyMed

Pharmacology for Ingredient: estradiol acetate

Ingredient-typeEstradiol Congeners
Drug ClassEstrogen
Mechanism of ActionEstrogen Receptor Agonists
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;ORAL021633-001Aug 20, 2004DISCNYesNo► Subscribe► SubscribeY ► Subscribe
Apil
FEMTRACE
estradiol acetate
TABLET;ORAL021633-002Aug 20, 2004DISCNYesNo► Subscribe► SubscribeY ► Subscribe
Apil
FEMTRACE
estradiol acetate
TABLET;ORAL021633-002Aug 20, 2004DISCNYesNo► Subscribe► Subscribe ► Subscribe
Apil
FEMTRACE
estradiol acetate
TABLET;ORAL021633-003Aug 20, 2004DISCNYesNo► Subscribe► SubscribeY ► Subscribe
Apil
FEMRING
estradiol acetate
INSERT, EXTENDED RELEASE;VAGINAL021367-002Mar 20, 2003RXYesYes► Subscribe► Subscribe► Subscribe
Apil
FEMTRACE
estradiol acetate
TABLET;ORAL021633-001Aug 20, 2004DISCNYesNo► Subscribe► SubscribeY ► Subscribe
Apil
FEMRING
estradiol acetate
INSERT, EXTENDED RELEASE;VAGINAL021367-001Mar 20, 2003RXYesNo► Subscribe► Subscribe► Subscribe
Apil
FEMTRACE
estradiol acetate
TABLET;ORAL021633-003Aug 20, 2004DISCNYesNo► Subscribe► SubscribeY ► Subscribe
Apil
FEMTRACE
estradiol acetate
TABLET;ORAL021633-002Aug 20, 2004DISCNYesNo► Subscribe► SubscribeY ► Subscribe
Apil
FEMTRACE
estradiol acetate
TABLET;ORAL021633-003Aug 20, 2004DISCNYesNo► Subscribe► Subscribe ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: estradiol acetate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil
FEMRING
estradiol acetate
INSERT, EXTENDED RELEASE;VAGINAL021367-001Mar 20, 2003► Subscribe► Subscribe
Apil
FEMRING
estradiol acetate
INSERT, EXTENDED RELEASE;VAGINAL021367-002Mar 20, 2003► Subscribe► Subscribe
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International Patent Family for Ingredient: estradiol acetate

Country Document Number Estimated Expiration
Israel160797► Subscribe
MexicoPA04006057► Subscribe
China1273141► Subscribe
Canada2470703► Subscribe
New Zealand532491► Subscribe
Australia2002359758► Subscribe
World Intellectual Property Organization (WIPO)03055495► Subscribe
Japan2005517673► Subscribe
European Patent Office1461043► Subscribe
Norway20042565► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: ESTRADIOL ACETATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0001France► SubscribePRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
2006 00038Denmark► SubscribePRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
00C/027Belgium► SubscribePRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
0814Netherlands► SubscribePRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
09/012Ireland► SubscribePRODUCT NAME: QLAIRA-ESTRADIOL VALERATE/DIENOGEST; NAT REGISTRATION NO/DATE: PA1410/58/1 20090109; FIRST REGISTRATION NO/DATE: BE327792 20081103
C/GB04/032United Kingdom► SubscribePRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310
C0022France► SubscribePRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
2009004,C0770388Lithuania► SubscribePRODUCT 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
C0002Belgium► SubscribePRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
C0005Belgium► SubscribePRODUCT NAME: ESTRADIOL HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: 298 IS 190 F 15 19960806; FIRST REGISTRATION: GB PL/0053/0241 19950711
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Farmers Insurance
QuintilesIMS
Queensland Health
McKinsey
Cipla
Julphar
Fuji
Federal Trade Commission
UBS
Medtronic

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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