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Last Updated: November 2, 2024

DROSPIRENONE; ESTRADIOL - Generic Drug Details


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What are the generic sources for drospirenone; estradiol and what is the scope of freedom to operate?

Drospirenone; estradiol is the generic ingredient in one branded drug marketed by Bayer Hlthcare and is included in one NDA. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Drospirenone; estradiol has twenty-one patent family members in sixteen countries.

One supplier is listed for this compound.

Summary for DROSPIRENONE; ESTRADIOL
International Patents:21
US Patents:1
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 49
DailyMed Link:DROSPIRENONE; ESTRADIOL at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for DROSPIRENONE; ESTRADIOL
Generic Entry Date for DROSPIRENONE; ESTRADIOL*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for DROSPIRENONE; ESTRADIOL

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
McGill University Health Centre/Research Institute of the McGill University Health CentrePhase 4
Eli Lilly and CompanyPhase 1
Bristol-Myers SquibbPhase 1

See all DROSPIRENONE; ESTRADIOL clinical trials

Pharmacology for DROSPIRENONE; ESTRADIOL
Drug ClassEstrogen
Progestin
Mechanism of ActionEstrogen Receptor Agonists
Paragraph IV (Patent) Challenges for DROSPIRENONE; ESTRADIOL
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ANGELIQ Tablets drospirenone; estradiol 0.25 mg/0.5 mg 021355 1 2015-01-08
ANGELIQ Tablets drospirenone; estradiol 0.5 mg/1 mg 021355 1 2007-12-26

US Patents and Regulatory Information for DROSPIRENONE; ESTRADIOL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare ANGELIQ drospirenone; estradiol TABLET;ORAL 021355-002 Sep 28, 2005 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bayer Hlthcare ANGELIQ drospirenone; estradiol TABLET;ORAL 021355-001 Feb 29, 2012 RX Yes No ⤷  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

International Patents for DROSPIRENONE; ESTRADIOL

Country Patent Number Title Estimated Expiration
Japan 2013523860 ⤷  Sign Up
Taiwan I519300 ⤷  Sign Up
Colombia 6630107 Formas de dosificación sólidas orales con dosis muy bajas para hrt ⤷  Sign Up
Eurasian Patent Organization 026095 ОЧЕНЬ НИЗКОДОЗИРОВАННЫЕ ТВЕРДЫЕ ПЕРОРАЛЬНЫЕ ЛЕКАРСТВЕННЫЕ ФОРМЫ ДЛЯ ГОРМОНОЗАМЕСТИТЕЛЬНОЙ ТЕРАПИИ (ГЗТ) (VERY LOW-DOSED SOLID ORAL DOSAGE FORMS FOR HORMONE REPLACEMENT THERAPY (HRT)) ⤷  Sign Up
European Patent Office 2558063 FORMULATION SOLIDE A TRÈS BAS DOSAGE POUR LA THERAPIE HORMONALE DE REMPLACEMENT (MENOPAUSE) (VERY LOW-DOSED SOLID ORAL DOSAGE FORMS FOR HRT) ⤷  Sign Up
China 102985070 Very low-dosed solid oral dosage forms for HRT ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for DROSPIRENONE; ESTRADIOL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0398460 04C0022 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
2588114 LUC00227 Luxembourg ⤷  Sign Up PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 31332 20191022
0398460 SPC/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
3632448 22C1031 France ⤷  Sign Up PRODUCT NAME: DROSPIRENONE; NAT. REGISTRATION NO/DATE: NL49691 20191121; FIRST REGISTRATION: DK - 31332 20191016
3632448 LUC00266 Luxembourg ⤷  Sign Up PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 61678, 20210401
>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.