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Serving 500+ biopharmaceutical companies globally:

Covington
Cerilliant
UBS
Boehringer Ingelheim
Harvard Business School
Mallinckrodt
Chinese Patent Office
Deloitte
Daiichi Sankyo
Baxter

Generated: June 25, 2017

DrugPatentWatch Database Preview

ELESTRIN Drug Profile

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What is the patent landscape for Elestrin, and when can generic versions of Elestrin launch?

Elestrin is a drug marketed by Mylan Speciality Lp and is included in one NDA. There are two patents protecting this drug.

This drug has fifty-one patent family members in eighteen countries.

The generic ingredient in ELESTRIN is estradiol. There are seventy-five drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the estradiol profile page.

Summary for Tradename: ELESTRIN

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Bulk Api Vendors: see list63
Clinical Trials: see list1
Patent Applications: see list9,758
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:ELESTRIN at DailyMed

Pharmacology for Tradename: ELESTRIN

Ingredient-typeEstradiol Congeners
Drug ClassEstrogen
Mechanism of ActionEstrogen Receptor Agonists
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Speciality Lp
ELESTRIN
estradiol
GEL, METERED;TRANSDERMAL021813-001Dec 15, 2006RXYesYes7,198,801► SubscribeY ► Subscribe
Mylan Speciality Lp
ELESTRIN
estradiol
GEL, METERED;TRANSDERMAL021813-001Dec 15, 2006RXYesYes7,470,433► SubscribeY ► Subscribe
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Non-Orange Book Patents for Tradename: ELESTRIN

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
7,404,965Composition for transdermal and/or transmucosal administration of active compounds that ensures adequate therapeutic levels► Subscribe
8,980,290Transdermal compositions for anticholinergic agents► Subscribe
8,980,309Transdermal testosterone formulation for minimizing skin residues► 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
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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 Tradename: ELESTRIN

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)0211768► Subscribe
Japan2007508261► Subscribe
Canada2515426► Subscribe
South Africa200505985► Subscribe
European Patent Office1670433► 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: ELESTRIN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2009Austria► SubscribePRODUCT NAME: KOMBINATION AUS ESTRADIOLVALERAT UND DIENOGEST; NAT. REGISTRATION NO/DATE: 1-28003 20090203; FIRST REGISTRATION: BE BE 327792 20081103
C0018France► SubscribePRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 20081103
2016 00016Denmark► SubscribePRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
/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
2009 00017Denmark► SubscribePRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Healthtrust
Argus Health
Julphar
Farmers Insurance
Moodys
Dow
Chubb
Chinese Patent Office
Queensland Health
Cipla

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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