.

BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Uncover prior art in expired and abandoned patents
  • Obtain formulation and manufacturing information

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

US Department of Justice
Mallinckrodt
Teva
Colorcon
Cantor Fitzgerald
Healthtrust
Boehringer Ingelheim
Federal Trade Commission
Fuji
Accenture

Generated: November 24, 2017

DrugPatentWatch Database Preview

Estradiol acetate - Generic Drug Details

« Back to Dashboard

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 and twenty-seven supplementary protection certificates in eleven countries.

There are seventy-five drug master file entries for estradiol acetate. Three suppliers are listed for this compound.

Pharmacology for 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;ORAL021633-003Aug 20, 2004DISCNYesNo► Subscribe► Subscribe ► Subscribe
Apil
FEMRING
estradiol acetate
INSERT, EXTENDED RELEASE;VAGINAL021367-001Mar 20, 2003RXYesNo► Subscribe► Subscribe► 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
FEMTRACE
estradiol acetate
TABLET;ORAL021633-002Aug 20, 2004DISCNYesNo► Subscribe► SubscribeY ► 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;ORAL021633-001Aug 20, 2004DISCNYesNo► Subscribe► SubscribeY ► Subscribe
Apil
FEMTRACE
estradiol acetate
TABLET;ORAL021633-003Aug 20, 2004DISCNYesNo► Subscribe► SubscribeY ► Subscribe
Apil
FEMTRACE
estradiol acetate
TABLET;ORAL021633-002Aug 20, 2004DISCNYesNo► Subscribe► Subscribe ► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: estradiol acetate

Country Document Number Estimated Expiration
Israel160797► Subscribe
MexicoPA04006057► Subscribe
Norway20042565► Subscribe
World Intellectual Property Organization (WIPO)03055495► Subscribe
China1564689► Subscribe
New Zealand532491► Subscribe
Japan2005517673► Subscribe
European Patent Office1461043► Subscribe
Canada2470703► Subscribe
China1273141► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

Supplementary Protection Certificates for Tradename: ESTRADIOL ACETATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
156Luxembourg► SubscribePRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
00221Netherlands► SubscribePRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
1214076/01Switzerland► SubscribePRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
2009 00017Denmark► SubscribePRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
2009004Lithuania► 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
C0003Belgium► SubscribePRODUCT NAME: ESTRADIOL AND NORETHISTERONE; FIRST REGISTRATION NO/DATE: 403 IS 106 F3 19980928; FIRST REGISTRATION: SE 14007 19980306
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
/2004Austria► SubscribePRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211
2009Austria► SubscribePRODUCT NAME: KOMBINATION AUS ESTRADIOLVALERAT UND DIENOGEST; NAT. REGISTRATION NO/DATE: 1-28003 20090203; FIRST REGISTRATION: BE BE 327792 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
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Farmers Insurance
Queensland Health
Covington
Boehringer Ingelheim
Merck
Moodys
Chubb
US Army
Dow
Argus Health

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot