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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
AstraZeneca
Colorcon
Chinese Patent Office
Teva
Fuji
Covington
Daiichi Sankyo
UBS

Generated: July 19, 2018

DrugPatentWatch Database Preview

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 thirteen patent family members in forty countries.

The generic ingredient in SAFYRAL is drospirenone; ethinyl estradiol; levomefolate calcium. There are ten 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.
Drug patent expirations by year for SAFYRAL
Generic Entry Opportunity Date for SAFYRAL
Generic Entry Date for SAFYRAL*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage::
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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

Non-Orange Book US Patents for SAFYRAL

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,569,557 Compositions of estrogen-cyclodextrin complexes ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for SAFYRAL

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:

Queensland Health
Chinese Patent Office
US Department of Justice
Covington
Deloitte
Fish and Richardson
Fuji
Johnson and Johnson
UBS

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 verifification 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.