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Generated: July 25, 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, 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, Teva Pharms Usa, Mylan Labs Ltd, Noven Pharms Inc, Barr, and Teva Womens, and is included in fifty-eight NDAs. There are eighteen 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-three 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:39
NDAs:58
Drug Master File Entries: see list75
Suppliers / Packagers: see list48
Bulk Api Vendors: see list63
Clinical Trials: see list673
Patent Applications: see list9,857
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
Bayer Hlthcare
MENOSTAR
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL021674-001Jun 8, 2004RXYesYes► Subscribe► SubscribeY ► Subscribe
Noven
MINIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL203752-003Oct 29, 2012RXYesNo► Subscribe► SubscribeYY ► Subscribe
Novartis
ESTRADERM
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL019081-003Sep 10, 1986DISCNYesNo► Subscribe► Subscribe► Subscribe
Novo Nordisk Inc
VAGIFEM
estradiol
TABLET;VAGINAL020908-002Nov 25, 2009ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Sandoz Inc
ESTRADIOL VALERATE
estradiol valerate
INJECTABLE;INJECTION040628-003Oct 4, 2007DISCNNoNo► 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
Novartis
VIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020323-005Aug 16, 2000► Subscribe► Subscribe
Allergan Sales Llc
ALORA
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020655-001Dec 20, 1996► Subscribe► Subscribe
Novartis
VIVELLE-DOT
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020538-009May 3, 2002► Subscribe► Subscribe
Women First Hlthcare
ESCLIM
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020847-002Aug 4, 1998► Subscribe► Subscribe
Novartis
VIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020323-005Aug 16, 2000► 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
8,980,290Transdermal compositions for anticholinergic agents► Subscribe
7,387,789Transdermal delivery of non-steroidal anti-inflammatory drugs► Subscribe
7,438,203Dermal penetration enhancers and drug delivery systems involving same► Subscribe
6,964,777 Transdermal delivery of antianxiety 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
Germany69739037► Subscribe
New Zealand524423► Subscribe
Austria324865► Subscribe
Hong Kong1155942► Subscribe
Hong Kong1101553► 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
972Luxembourg► Subscribe91972, EXPIRES: 20220219
00C/027Belgium► SubscribePRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
0814Netherlands► SubscribePRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
/2004Austria► SubscribePRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211
2012 00011Denmark► Subscribe
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Merck
AstraZeneca
Accenture
Citi
UBS
Colorcon
Queensland Health
Chinese Patent Office
Daiichi Sankyo
US Department of Justice

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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