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Generated: September 24, 2017

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Estradiol - Generic Drug Details

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What are the generic drug sources for estradiol and what is the scope of estradiol patent protection?

Estradiol
is the generic ingredient in thirty-eight branded drugs marketed by Bristol Myers Squibb, Novo Nordisk Inc, Duramed Pharms Barr, Mylan Speciality Lp, Perrigo Pharma Intl, 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, Teva Pharms Usa, Barr Labs Inc, Usl Pharma, Apil, Watson Labs, Exeltis Usa Inc, Par Sterile Products, Luitpold, Sandoz Inc, Watson Labs Inc, Savage Labs, Amneal Pharms Llc, Breckenridge Pharm, Lupin Ltd, Mylan Labs Ltd, Noven Pharms Inc, Barr, and Teva Womens, and is included in fifty-nine NDAs. There are nineteen patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Estradiol has one hundred and eighty-four patent family members in thirty-four countries.

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

Summary for Generic Name: estradiol

Tradenames:38
Patents:19
Applicants:39
NDAs:59
Drug Master File Entries: see list75
Suppliers / Packagers: see list49
Bulk Api Vendors: see list63
Clinical Trials: see list684
Patent Applications: see list6,572
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. Strength Dosage Form
► Subscribe► Subscribe1MG;2MG;2MGTABLET;ORAL
► Subscribe► Subscribe3MG;2MG;3MGTABLET;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal Pharms
ESTRADIOL
estradiol
TABLET;VAGINAL205256-001May 29, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Novartis
VIVELLE-DOT
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020538-007Jan 8, 1999AB1RXYesNo► Subscribe► Subscribe► Subscribe
Novartis
ESTRADERM
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL019081-002Sep 10, 1986DISCNYesNo► Subscribe► Subscribe► Subscribe
Novo Nordisk Inc
INNOFEM
estradiol
TABLET;ORAL040312-002Nov 19, 1999DISCNNoNo► Subscribe► Subscribe► Subscribe
Noven
MINIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL203752-003Oct 29, 2012RXYesNo► Subscribe► SubscribeYY ► Subscribe
Mylan Technologies
ESTRADIOL
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL075182-002Jan 26, 2005AB2RXNoNo► Subscribe► Subscribe► Subscribe
Noven
MINIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL203752-005Sep 23, 2014RXYesNo► Subscribe► SubscribeYY ► Subscribe
Mylan Technologies
ESTRADIOL
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL075182-004Jul 20, 2006ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan
ESTRADIOL
estradiol
TABLET;ORAL040326-002Apr 21, 1999ABRXNoNo► Subscribe► Subscribe► Subscribe
Lannett Holdings Inc
ESTRADIOL
estradiol
TABLET;ORAL040138-003Jan 30, 1998DISCNNoNo► Subscribe► 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, 1996► Subscribe► Subscribe
Novartis
VIVELLE-DOT
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020538-005Jan 8, 1999► Subscribe► Subscribe
Allergan Sales Llc
ESTRACE
estradiol
CREAM;VAGINAL086069-001Jan 31, 1984► Subscribe► Subscribe
Novartis
VIVELLE-DOT
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020538-005Jan 8, 1999► Subscribe► Subscribe
Novartis
VIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020323-004Oct 28, 1994► Subscribe► Subscribe
Novartis
VIVELLE-DOT
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020538-006Jan 8, 1999► Subscribe► Subscribe
Novartis
VIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020323-002Oct 28, 1994► Subscribe► Subscribe
Novartis
VIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020323-001Oct 28, 1994► Subscribe► Subscribe
Noven
MINIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL203752-001Oct 29, 2012► Subscribe► Subscribe
Novartis
VIVELLE-DOT
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020538-007Jan 8, 1999► Subscribe► 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
6,964,777 Transdermal delivery of antianxiety agents► Subscribe
6,916,487 Transdermal delivery of antiemetics► Subscribe
7,214,381Composition for transdermal and/or transmucosal administration of active compounds that ensures adequate therapeutic levels► Subscribe
8,652,491Transdermal compositions for anticholinergic agents► Subscribe
8,071,075Dermal penetration enhancers and drug delivery systems involving the same► Subscribe
6,998,138Topical delivery of anti-alopecia agents► Subscribe
7,387,789Transdermal delivery of non-steroidal anti-inflammatory drugs► Subscribe
7,404,965Composition for transdermal and/or transmucosal administration of active compounds that ensures adequate therapeutic levels► Subscribe
7,438,203Dermal penetration enhancers and drug delivery systems involving same► Subscribe
7,387,788Pharmaceutical compositions of nicotine and methods of use thereof► 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
Germany69739931► Subscribe
New Zealand546106► Subscribe
Japan2011236250► Subscribe
Japan2007524589► Subscribe
European Patent Office1343508► Subscribe
Spain2299912► Subscribe
Japan2007508261► Subscribe
Luxembourg91972► Subscribe
Austria291430► Subscribe
Japan4864695► 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
00523Netherlands► SubscribePRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
/2004Austria► SubscribePRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211
156Luxembourg► SubscribePRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
0814Netherlands► SubscribePRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
C0002Belgium► SubscribePRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
972Luxembourg► Subscribe91972, EXPIRES: 20220219
/2015Austria► SubscribePRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
00521Netherlands► SubscribePRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
00C/027Belgium► SubscribePRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
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
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Chubb
Fish and Richardson
US Army
Johnson and Johnson
Medtronic
Argus Health
QuintilesIMS
Novartis
Express Scripts
Dow

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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