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Estradiol - Generic Drug Details

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Estradiol is the generic ingredient in thirty-eight branded drugs marketed by Bristol Myers Squibb, Novo Nordisk Inc, Duramed Pharms Barr, Meda Pharms, Elan Pharma Intl Ltd, Mayne Pharma, Parke Davis, Novartis, Mylan, Vertical Pharms Llc, Lannett Holdings Inc, Women First Hlthcare, Ortho Mcneil Pharm, Noven, Allergan Sales Llc, Amneal Pharms, Ascend Theraps Us, Pharmacia And Upjohn, Bayer Hlthcare, Mylan Technologies, Epic Pharma Inc, Barr Labs Inc, Usl Pharma, Apil, Watson Labs, Exeltis Usa Inc, Par Sterile Products, Luitpold, Sandoz, Watson Labs Inc, Savage Labs, Amneal Pharms Llc, Breckenridge Pharm, Lupin Ltd, Teva Pharms Usa, Mylan Labs Ltd, Noven Pharms Inc, Barr, and Teva Womens, and is included in fifty-eight NDAs. There are seventeen patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has one hundred and seventy-nine patent family members in thirty-four countries.

There are seventy-five drug master file entries for estradiol. Forty-eight suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: estradiol

Tradenames:38
Patents:17
Applicants:39
NDAs:58
Drug Master File Entries: see list75
Suppliers / Packagers: see list48
Bulk Api Vendors: see list63
Clinical Trials: see list264
Patent Applications: see list19,678
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:estradiol at DailyMed

Pharmacology for Ingredient: estradiol

Ingredient-typeEstradiol Congeners
Drug ClassEstrogen
Mechanism of ActionEstrogen Receptor Agonists

Tentative approvals for ESTRADIOL

Applicant Application No. Form Dosage
<disabled><disabled>TABLET;ORAL1MG;2MG;2MG
<disabled><disabled>TABLET;ORAL3MG;2MG;3MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan
ESTRADIOL
estradiol
TABLET;ORAL040326-003Apr 21, 1999RXNoNo► subscribe► subscribe
Mylan Labs Ltd
ESTRADIOL AND NORETHINDRONE ACETATE
estradiol; norethindrone acetate
TABLET;ORAL207261-002Feb 10, 2017RXNoNo► subscribe► subscribe
Lannett Holdings Inc
ESTRADIOL
estradiol
TABLET;ORAL040138-002Jan 30, 1998DISCNNoNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: estradiol

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan Sales Llc
ALORA
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020655-003Dec 20, 19965,227,169► subscribe
Bayer Hlthcare
CLIMARA
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020375-006May 27, 20035,223,261► subscribe
Allergan Sales Llc
ALORA
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020655-002Dec 20, 19965,164,190► subscribe
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Non-Orange Book Patents for Generic Ingredient: estradiol

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,916,486 Transdermal delivery of analgesics► subscribe
8,652,491Transdermal compositions for anticholinergic agents► subscribe
7,404,965Composition for transdermal and/or transmucosal administration of active compounds that ensures adequate therapeutic levels► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: estradiol

Country Document Number Estimated Expiration
European Patent Office1570848► subscribe
Japan2007508261► subscribe
Portugal1343508► 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

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
156Luxembourg► subscribePRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
C0004Belgium► subscribePRODUCT NAME: ESTRADIOL, HEMIHYDRATE, NORETHISTERONE, ACETATE; NAT. REGISTRATION NO/DATE: NL 23753 19981210; FIRST REGISTRATION: SE - 14 007 19980306
C0018France► subscribePRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 20081103
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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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