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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, Noven Pharms Inc, Barr, and Teva Womens, and is included in fifty-seven NDAs. There are eighteen 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-eight 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:18
Applicants:38
NDAs:57
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

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 Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis
VIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020323-005Aug 16, 2000DISCNNo► subscribe► subscribe
Mylan Technologies
ESTRADIOL
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL201675-002Dec 19, 2014RXNo► subscribe► subscribe
Pharmacia And Upjohn
DEPO-ESTRADIOL
estradiol cypionate
INJECTABLE;INJECTION085470-001Approved Prior to Jan 1, 1982DISCNNo► 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
Novartis
VIVELLE-DOT
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020538-008Jan 8, 19995,474,783► subscribe
Novartis
VIVELLE-DOT
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020538-006Jan 8, 19995,958,446► subscribe
Bayer Hlthcare
CLIMARA
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020375-002Dec 22, 19945,223,261► 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
6,929,801 Transdermal delivery of antiparkinson agents► subscribe
8,980,290Transdermal compositions for anticholinergic agents► subscribe
6,998,138Topical delivery of anti-alopecia agents► 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 Office1769785► subscribe
New Zealand538322► subscribe
Portugal901368► 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
09/012Ireland► subscribePRODUCT NAME: QLAIRA-ESTRADIOL VALERATE/DIENOGEST; NAT REGISTRATION NO/DATE: PA1410/58/1 20090109; FIRST REGISTRATION NO/DATE: BE327792 20081103
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
2012 00010Denmark► subscribe
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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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