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Last Updated: January 24, 2020

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SAFYRAL Drug Profile

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When do Safyral patents expire, and when can generic versions of Safyral launch?

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 twenty 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. Three suppliers are listed for this compound. Additional details are available on the drospirenone; ethinyl estradiol; levomefolate calcium profile page.

US ANDA Litigation and Generic Entry Outlook for Safyral

Safyral was eligible for patent challenges on December 31, 1968.

There have been eleven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for SAFYRAL
Drug Prices for SAFYRAL

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Recent Litigation for SAFYRAL

Identify potential future generic entrants

District Court Litigation
Case NameDate
Merck & Cie v. Lupin Ltd.2015-10-08
Merck & Cie v. Watson Laboratories Inc.2015-09-24
Merck & Cie v. Watson Laboratories Inc.2013-07-23

See all SAFYRAL litigation

Paragraph IV (Patent) Challenges for SAFYRAL
Tradename Dosage Ingredient NDA Submissiondate
SAFYRAL TABLET;ORAL drospirenone; ethinyl estradiol; levomefolate calcium 022574 2012-09-28

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   Start Trial   Start Trial   Start Trial
Bayer Hlthcare SAFYRAL drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022574-001 Dec 16, 2010 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Bayer Hlthcare SAFYRAL drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022574-001 Dec 16, 2010 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Bayer Hlthcare SAFYRAL drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022574-001 Dec 16, 2010 AB RX Yes Yes   Start Trial   Start Trial Y   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 SAFYRAL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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