Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 13, 2019

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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-two patent family members in seventeen countries.

There are eleven drug master file entries for drospirenone; estradiol. One supplier is listed for this compound.

Summary for DROSPIRENONE; ESTRADIOL
Recent Clinical Trials for DROSPIRENONE; ESTRADIOL

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SponsorPhase
University of California, San FranciscoPhase 4
BayerPhase 1
Navy General Hospital, BeijingN/A

See all DROSPIRENONE; ESTRADIOL clinical trials

Recent Litigation for DROSPIRENONE; ESTRADIOL

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District Court Litigation
Case NameDate
Bayer Schering Pharma AG v. Mylan Pharmaceuticals Inc.2011-04-19
Bayer Schering Pharma AG v. Sun Pharmaceutical Industries, Inc.2011-01-12
Bayer Schering Pharma AG v. Lupin Ltd.2010-07-15

See all DROSPIRENONE; ESTRADIOL litigation

Pharmacology for DROSPIRENONE; ESTRADIOL
Paragraph IV (Patent) Challenges for DROSPIRENONE; ESTRADIOL
Tradename Dosage Ingredient NDA Submissiondate
ANGELIQ TABLET;ORAL drospirenone; estradiol 021355 2015-01-08
ANGELIQ TABLET;ORAL drospirenone; estradiol 021355 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 021355-001 Feb 29, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
Bayer Hlthcare ANGELIQ drospirenone; estradiol TABLET;ORAL 021355-002 Sep 28, 2005 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for DROSPIRENONE; ESTRADIOL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0398460 SPC/GB04/032 United Kingdom   Start Trial PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310
0398460 04C0022 France   Start Trial PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Harvard Business School
Medtronic
Express Scripts

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