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Serving 500+ biopharmaceutical companies globally:

McKinsey
Cerilliant
Julphar
Queensland Health
Healthtrust
Farmers Insurance
Boehringer Ingelheim
McKesson
Medtronic
Cantor Fitzgerald

Generated: August 21, 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-nine 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, 2006RXYesYes► Subscribe► SubscribeY ► Subscribe
Mylan Speciality Lp
ELESTRIN
estradiol
GEL, METERED;TRANSDERMAL021813-001Dec 15, 2006RXYesYes► Subscribe► 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
7,214,381Composition for transdermal and/or transmucosal administration of active compounds that ensures adequate therapeutic levels► Subscribe
8,652,491Transdermal compositions for anticholinergic agents► Subscribe
7,387,788Pharmaceutical compositions of nicotine and methods of use thereof► Subscribe
8,980,309Transdermal testosterone formulation for minimizing skin residues► Subscribe
7,335,379Transdermal pharmaceutical formulation for minimizing skin residues► 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
Mexico343811► Subscribe
Japan2011236250► Subscribe
BrazilPI0408153► Subscribe
European Patent Office1325752► Subscribe
China105853396► 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
2015000093Germany► SubscribePRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
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
C/GB04/032United Kingdom► SubscribePRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310
2016 00016Denmark► SubscribePRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
C0022France► SubscribePRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Novartis
Deloitte
Medtronic
Teva
Federal Trade Commission
Covington
Moodys
Chubb
Chinese Patent Office
Johnson and Johnson

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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