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Last Updated: March 29, 2024

ELESTRIN Drug Patent Profile


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Which patents cover Elestrin, and when can generic versions of Elestrin launch?

Elestrin is a drug marketed by Mylan Speciality Lp and is included in one NDA.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Elestrin

A generic version of ELESTRIN was approved as estradiol by BARR LABS INC on October 22nd, 1997.

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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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ELESTRIN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan Speciality Lp ELESTRIN estradiol GEL, METERED;TRANSDERMAL 021813-001 Dec 15, 2006 ⤷  Try a Trial ⤷  Try a Trial
Mylan Speciality Lp ELESTRIN estradiol GEL, METERED;TRANSDERMAL 021813-001 Dec 15, 2006 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ELESTRIN

See the table below for patents covering ELESTRIN around the world.

Country Patent Number Title Estimated Expiration
Canada 2418135 COMPOSITION POUR L'ADMINISTRATION TRANSDERMIQUE ET/OU TRANSMUQUEUSE DE COMPOSES ACTIFS ASSURANT DES NIVEAUX D'EFFICACITE THERAPEUTIQUE ADEQUATS (NOVEL COMPOSITION FOR TRANSDERMAL AND/OR TRANSMUCOSAL ADMINISTRATION OF ACTIVE COMPOUNDS THAT ENSURES ADEQUATE THERAPEUTIC LEVELS) ⤷  Try a Trial
European Patent Office 1323431 Composition pour l' administration percutanée et/ou par voie transmucosale de principes actifs assurant des niveaux d' efficacité thérapeutiques adéquats (Composition for transdermal and/or transmucosal administration of active compounds that ensures adequate therapeutic levels) ⤷  Try a Trial
Denmark 1670433 ⤷  Try a Trial
Australia 8206401 ⤷  Try a Trial
Japan 2011236250 USE AND FORMULATION FOR TRANSDERMAL OR TRANSMUCOSAL APPLICATION OF ACTIVE AGENT ⤷  Try a Trial
European Patent Office 1670433 FORMULATION PHARMACEUTIQUE TRANSDERMIQUE VISANT A REDUIRE LES RESIDUS SUR LA PEAU (TRANSDERMAL PHARMACEUTICAL FORMULATION FOR MINIMIZING SKIN RESIDUES) ⤷  Try a Trial
Japan 2007524589 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ELESTRIN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0770388 PA2009004,C0770388 Lithuania ⤷  Try a Trial PRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103
1453521 C 2015 029 Romania ⤷  Try a Trial PRODUCT NAME: LEVONORGESTREL SI ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: RO 7793/2015/001; DATE OF NATIONAL AUTHORISATION: 20150612; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): SK. 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150129
0402407 97C0005 Belgium ⤷  Try a Trial PRODUCT NAME: ESTRADIOL HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: 298 IS 190 F 15 19960806; FIRST REGISTRATION: GB PL/0053/0241 19950711
1214076 SZ 49/2008 Austria ⤷  Try a Trial PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
1380301 CA 2009 00017 Denmark ⤷  Try a Trial PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
2782584 21C1058 France ⤷  Try a Trial PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17SS-ESTRADIOL), Y COMPRIS SOUS FORME HEMIHYDRATEE, ET DE LA PROGESTERONE; NAT. REGISTRATION NO/DATE: NL51886 20210421; FIRST REGISTRATION: BE - BE582231 20210406
0285237 95C0008 Belgium ⤷  Try a Trial PRODUCT NAME: ESTRADIOL, HEMIHYDRATE; NAT. REGISTRATION NO/DATE: NL 19489 19941107; FIRST REGISTRATION: FR - NL 19489 19941107
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.