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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
McKesson
Farmers Insurance
Harvard Business School
Covington
Moodys
Healthtrust
Federal Trade Commission
Dow

Generated: December 11, 2018

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Safyral Drug Profile

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Which patents cover Safyral, and what generic alternatives are available?

Safyral is a drug marketed by Bayer Hlthcare and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and thirteen patent family members in forty countries.

The generic ingredient in SAFYRAL is drospirenone; ethinyl estradiol; levomefolate calcium. There are eleven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the drospirenone; ethinyl estradiol; levomefolate calcium profile page.

US Patents and Regulatory Information for Safyral

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 ➤ 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
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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Paragraph IV (Patent) Challenges for SAFYRAL
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 3 mg/0.03 mg/0.451 mg and 0.451 mg ➤ Subscribe ➤ Try a Free Trial

International Patents for Safyral

Country Document Number Estimated Expiration
European Patent Office 1695975 ➤ Try a Free Trial
Japan 4782364 ➤ Try a Free Trial
New Zealand 526847 ➤ Try a Free Trial
Estonia 200300298 ➤ Try a Free Trial
South Korea 20030070905 ➤ Try a Free Trial
Slovakia 287500 ➤ Try a Free Trial
Japan 2013047278 ➤ Try a Free Trial
Country Document Number Estimated Expiration

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Supplementary Protection Certificates for Safyral

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:

McKinsey
Fuji
McKesson
UBS
Accenture
Johnson and Johnson
Citi
US Department of Justice
Cerilliant

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