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Serving leading biopharmaceutical companies globally:

Baxter
Healthtrust
Daiichi Sankyo
Mallinckrodt
Teva
Johnson and Johnson
US Department of Justice
Harvard Business School
Covington
Julphar

Generated: February 21, 2018

DrugPatentWatch Database Preview

ELESTRIN Drug Profile

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When do Elestrin patents expire, 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-three 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 ELESTRIN
Drug patent expirations by year for ELESTRIN
Pharmacology for ELESTRIN
Ingredient-typeEstradiol Congeners
Drug ClassEstrogen
Mechanism of ActionEstrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories for ELESTRIN

US Patents and Regulatory Information for ELESTRIN

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;TRANSDERMAL 021813-001 Dec 15, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Mylan Speciality Lp ELESTRIN estradiol GEL, METERED;TRANSDERMAL 021813-001 Dec 15, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for 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
7,214,381 Composition for transdermal and/or transmucosal administration of active compounds that ensures adequate therapeutic levels ➤ Sign Up
7,404,965 Composition for transdermal and/or transmucosal administration of active compounds that ensures adequate therapeutic levels ➤ Sign Up
8,652,491 Transdermal compositions for anticholinergic agents ➤ Sign Up
8,980,309 Transdermal testosterone formulation for minimizing skin residues ➤ Sign Up
8,980,290 Transdermal compositions for anticholinergic agents ➤ Sign Up
7,335,379 Transdermal pharmaceutical formulation for minimizing skin residues ➤ Sign Up
7,387,788 Pharmaceutical compositions of nicotine and methods of use thereof ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for ELESTRIN

Supplementary Protection Certificates for ELESTRIN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0018 France ➤ Sign Up PRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 20081103
49/2008 Austria ➤ Sign Up PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
C0004 Belgium ➤ Sign Up PRODUCT NAME: ESTRADIOL, HEMIHYDRATE, NORETHISTERONE, ACETATE; NAT. REGISTRATION NO/DATE: NL 23753 19981210; FIRST REGISTRATION: SE - 14 007 19980306
2009 Austria ➤ Sign Up PRODUCT NAME: KOMBINATION AUS ESTRADIOLVALERAT UND DIENOGEST; NAT. REGISTRATION NO/DATE: 1-28003 20090203; FIRST REGISTRATION: BE BE 327792 20081103
C0003 Belgium ➤ Sign Up PRODUCT NAME: ESTRADIOL AND NORETHISTERONE; FIRST REGISTRATION NO/DATE: 403 IS 106 F3 19980928; FIRST REGISTRATION: SE 14007 19980306
C0022 France ➤ Sign Up PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
00221 Netherlands ➤ Sign Up PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
2016 00016 Denmark ➤ Sign Up PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
00C/027 Belgium ➤ Sign Up PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
C/GB04/032 United Kingdom ➤ Sign Up PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
McKinsey
Medtronic
Baxter
Johnson and Johnson
Moodys
Accenture
Healthtrust
Cantor Fitzgerald

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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