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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Cipla
Medtronic
Boehringer Ingelheim
Cerilliant
Fish and Richardson
Accenture
Deloitte
Healthtrust
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Generated: October 24, 2017

DrugPatentWatch Database Preview

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 ninety-seven patent family members in thirty-four countries and thirty-five supplementary protection certificates in eleven 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

US Patents:19
Tradenames:38
Applicants:39
NDAs:59
Drug Master File Entries: see list75
Suppliers / Packagers: see list49
Bulk Api Vendors: see list63
Clinical Trials: see list692
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
u► Subscribe1MG;2MG;2MGTABLET;ORAL
u► 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
Mylan Technologies
ESTRADIOL
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL075182-006Feb 24, 2000AB2RXNoNo► Subscribe► Subscribe► Subscribe
Noven
MINIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL203752-003Oct 29, 2012RXYesNo► Subscribe► Subscribe ► Subscribe
Noven
MINIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL203752-005Sep 23, 2014RXYesNo► Subscribe► SubscribeYY ► Subscribe
Bristol Myers Squibb
ESTRACE
estradiol
TABLET;ORAL081295-001Jun 30, 1993DISCNNoNo► Subscribe► Subscribe► Subscribe
Mylan Technologies
ESTRADIOL
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL201675-003Dec 19, 2014AB1RXNoNo► Subscribe► Subscribe► Subscribe
Duramed Pharms Barr
GYNODIOL
estradiol
TABLET;ORAL040212-004Dec 29, 1997DISCNNoNo► Subscribe► Subscribe► Subscribe
Mylan Technologies
ESTRADIOL
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL201675-005Dec 19, 2014AB1RXNoNo► Subscribe► Subscribe► Subscribe
Usl Pharma
ESTRADIOL
estradiol
TABLET;ORAL040297-001Apr 17, 2002DISCNNoNo► Subscribe► Subscribe► Subscribe
Mylan Technologies
ESTRADIOL
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL201675-001Dec 19, 2014AB1RXNoNo► Subscribe► Subscribe► Subscribe
Bristol Myers Squibb
ESTRACE
estradiol
TABLET;ORAL084499-001Approved Prior to Jan 1, 1982DISCNNoNo► 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
Bayer Hlthcare
CLIMARA
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020375-002Dec 22, 1994► Subscribe► Subscribe
Pharmacia And Upjohn
ESTRING
estradiol
INSERT, EXTENDED RELEASE;VAGINAL020472-001Apr 26, 1996► Subscribe► Subscribe
Novartis
VIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020323-002Oct 28, 1994► Subscribe► Subscribe
Women First Hlthcare
ESCLIM
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020847-004Aug 4, 1998► Subscribe► Subscribe
Novartis
VIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020323-001Oct 28, 1994► Subscribe► Subscribe
Novartis
VIVELLE-DOT
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020538-009May 3, 2002► Subscribe► Subscribe
Allergan Sales Llc
ALORA
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020655-002Dec 20, 1996► Subscribe► Subscribe
Pharmacia And Upjohn
ESTRING
estradiol
INSERT, EXTENDED RELEASE;VAGINAL020472-001Apr 26, 1996► Subscribe► Subscribe
Bayer Hlthcare
CLIMARA
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020375-001Dec 22, 1994► 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
7,094,422Topical delivery of antifungal agents► Subscribe
6,929,801 Transdermal delivery of antiparkinson agents► Subscribe
7,214,381Composition for transdermal and/or transmucosal administration of active compounds that ensures adequate therapeutic levels► Subscribe
6,964,777 Transdermal delivery of antianxiety agents► Subscribe
6,916,486 Transdermal delivery of analgesics► Subscribe
6,998,138Topical delivery of anti-alopecia agents► Subscribe
8,980,309Transdermal testosterone formulation for minimizing skin residues► Subscribe
6,916,487 Transdermal delivery of antiemetics► Subscribe
8,652,491Transdermal compositions for anticholinergic agents► Subscribe
8,071,075Dermal penetration enhancers and drug delivery systems involving the same► 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
New Zealand546106► Subscribe
World Intellectual Property Organization (WIPO)2004080413► Subscribe
Austria253355► Subscribe
Portugal1769785► Subscribe
Mexico343811► Subscribe
Austria472997► Subscribe
Slovakia7332000► Subscribe
Japan4864695► Subscribe
Hong Kong1087355► Subscribe
Germany20120246► 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
C0002Belgium► SubscribePRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
1214076/01Switzerland► SubscribePRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
C0008Belgium► SubscribePRODUCT NAME: ESTRADIOL, HEMIHYDRATE; NAT. REGISTRATION NO/DATE: NL 19489 19941107; FIRST REGISTRATION: FR - NL 19489 19941107
2009004,C0770388Lithuania► 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
972Luxembourg► Subscribe91972, EXPIRES: 20220219
0136011/03Switzerland► SubscribePRODUCT NMAE: ESTRADIOL UND MEDROXYPROGESTERONACETAT; REGISTRATION NO/DATE: IKS 55288 20000417
2012 00010Denmark► Subscribe
C0005Belgium► SubscribePRODUCT NAME: ESTRADIOL HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: 298 IS 190 F 15 19960806; FIRST REGISTRATION: GB PL/0053/0241 19950711
C0004Belgium► SubscribePRODUCT NAME: ESTRADIOL, HEMIHYDRATE, NORETHISTERONE, ACETATE; NAT. REGISTRATION NO/DATE: NL 23753 19981210; FIRST REGISTRATION: SE - 14 007 19980306
00523Netherlands► SubscribePRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Argus Health
McKesson
US Department of Justice
Daiichi Sankyo
Medtronic
US Army
Fuji
Teva
Queensland Health
Merck

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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