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ELESTRIN Drug Profile

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Which patents cover Elestrin, and what substitute generic drugs are available?

Elestrin is a drug marketed by Meda Pharms and is included in one NDA. There are two patents protecting this drug.

This drug has fifty 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. There is one tentative approval 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 Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Meda Pharms
ELESTRIN
estradiol
GEL, METERED;TRANSDERMAL021813-001Dec 15, 2006RXYesYes7,470,433► SubscribeY ► Subscribe
Meda Pharms
ELESTRIN
estradiol
GEL, METERED;TRANSDERMAL021813-001Dec 15, 2006RXYesYes7,198,801► 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
8,980,290Transdermal compositions for anticholinergic agents► Subscribe
8,980,309Transdermal testosterone formulation for minimizing skin residues► Subscribe
7,404,965Composition for transdermal and/or transmucosal administration of active compounds that ensures adequate therapeutic levels► 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
Portugal1670433► Subscribe
New Zealand541854► Subscribe
Canada2538856► Subscribe
Japan2011236250► Subscribe
Spain2283665► 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
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
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
C0018France► SubscribePRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 20081103
0814Netherlands► SubscribePRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
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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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