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Last Updated: June 5, 2020

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SAFYRAL Drug Profile


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When do Safyral patents expire, 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 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

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

Synonyms for SAFYRAL
914956-24-4
Beyaz
Drospirenone / ethinylestradiol / levomefolate calcium
Drospirenone mixture with ethinylestradiol and levomefolate calcium
Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium
DTXSID30238596
Tydemy
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

Expired US Patents for SAFYRAL

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   Start Trial   Start Trial
Bayer Hlthcare SAFYRAL drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022574-001 Dec 16, 2010   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for SAFYRAL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0771217 CA 2006 00038 Denmark   Start Trial PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
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
0771217 07C0001 France   Start Trial PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Medtronic
AstraZeneca
Moodys
Mallinckrodt
Dow
Colorcon

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.