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Estradiol acetate - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for estradiol acetate?

Estradiol acetate is the generic ingredient in two branded drugs marketed by Apil and is included in two NDAs. There are four 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:4
Applicants:1
NDAs:2
Drug Master File Entries: see list75
Suppliers / Packagers: see list3
Bulk Api Vendors: see list5
Clinical Trials: see list657
Patent Applications: see list359
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 Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apil
FEMTRACE
estradiol acetate
TABLET;ORAL021633-002Aug 20, 2004RXYesNo7,799,771► SubscribeY ► Subscribe
Apil
FEMTRACE
estradiol acetate
TABLET;ORAL021633-001Aug 20, 2004RXYesNo6,962,908► SubscribeY ► Subscribe
Apil
FEMTRACE
estradiol acetate
TABLET;ORAL021633-001Aug 20, 2004RXYesNo7,799,771► SubscribeY ► Subscribe
Apil
FEMTRACE
estradiol acetate
TABLET;ORAL021633-002Aug 20, 2004RXYesNo6,962,908► SubscribeY ► Subscribe
Apil
FEMTRACE
estradiol acetate
TABLET;ORAL021633-003Aug 20, 2004RXYesYes6,962,908► SubscribeY ► 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, 20035,855,906► Subscribe
Apil
FEMRING
estradiol acetate
INSERT, EXTENDED RELEASE;VAGINAL021367-002Mar 20, 20035,855,906► Subscribe
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International Patent Family for Ingredient: estradiol acetate

Country Document Number Estimated Expiration
European Patent Office1461043► Subscribe
Canada2470703► Subscribe
China1564689► Subscribe
Israel160797► Subscribe
China1273141► 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
156Luxembourg► SubscribePRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
C0022France► SubscribePRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
/2004Austria► SubscribePRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211
C0003Belgium► SubscribePRODUCT NAME: ESTRADIOL AND NORETHISTERONE; FIRST REGISTRATION NO/DATE: 403 IS 106 F3 19980928; FIRST REGISTRATION: SE 14007 19980306
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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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