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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

Generated: October 16, 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.

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 BEYAZ drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022532-001 Sep 24, 2010 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Bayer Hlthcare BEYAZ drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022532-001 Sep 24, 2010 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Watson Labs Inc DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 203593-001 Oct 11, 2016 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Bayer Hlthcare SAFYRAL drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022574-001 Dec 16, 2010 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Bayer Hlthcare SAFYRAL drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022574-001 Dec 16, 2010 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Bayer Hlthcare SAFYRAL drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022574-001 Dec 16, 2010 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
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

International Patents for drospirenone; ethinyl estradiol; levomefolate calcium

Country Document Number Estimated Expiration
Portugal 1632237 ➤ Try a Free Trial
New Zealand 526847 ➤ Try a Free Trial
Bulgaria 108002 ➤ Try a Free Trial
Spain 2374369 ➤ Try a Free Trial
Japan 5675759 ➤ Try a Free Trial
Eurasian Patent Organization 007411 ➤ Try a Free Trial
Country Document Number Estimated Expiration

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Supplementary Protection Certificates for drospirenone; ethinyl estradiol; levomefolate calcium

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