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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
AstraZeneca
US Department of Justice
Queensland Health
Cerilliant
Dow
Colorcon
Teva
Chubb

Generated: December 10, 2018

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Drospirenone; ethinyl estradiol; levomefolate calcium - Generic Drug Details

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

Drospirenone; ethinyl estradiol; levomefolate calcium is the generic ingredient in four branded drugs marketed by Bayer Hlthcare, Watson Labs Inc, and Lupin Ltd, and is included in six NDAs. There are four patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Drospirenone; ethinyl estradiol; levomefolate calcium has one hundred and thirteen patent family members in forty countries.

There are eleven drug master file entries for drospirenone; ethinyl estradiol; levomefolate calcium. Four suppliers are listed for this compound.

US Patents and Regulatory Information for drospirenone; ethinyl estradiol; levomefolate calcium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare SAFYRAL drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022574-001 Dec 16, 2010 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Lupin Ltd DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 205947-001 Jun 13, 2018 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Bayer Hlthcare BEYAZ drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022532-001 Sep 24, 2010 AB RX No No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Bayer Hlthcare BEYAZ drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022532-001 Sep 24, 2010 AB RX No 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

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Expired US Patents for drospirenone; ethinyl estradiol; levomefolate calcium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare SAFYRAL drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022574-001 Dec 16, 2010 ➤ Sign Up ➤ Sign Up
Bayer Hlthcare BEYAZ drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022532-001 Sep 24, 2010 ➤ Sign Up ➤ Sign Up
Bayer Hlthcare BEYAZ drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022532-001 Sep 24, 2010 ➤ Sign Up ➤ Sign Up
Bayer Hlthcare BEYAZ drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022532-001 Sep 24, 2010 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for drospirenone; ethinyl estradiol; levomefolate calcium

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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:

US Army
QuintilesIMS
Argus Health
Deloitte
Fish and Richardson
Teva
Cantor Fitzgerald
AstraZeneca
Chinese Patent Office

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