.

BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Obtain formulation and manufacturing information

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Covington
Chubb
US Department of Justice
McKesson
Argus Health
Teva
Harvard Business School
Boehringer Ingelheim
McKinsey
Accenture

Generated: December 13, 2017

DrugPatentWatch Database Preview

Safyral Drug Profile

« Back to Dashboard

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 twelve patent family members in forty countries and two supplementary protection certificates in two countries.

The generic ingredient in SAFYRAL is drospirenone; ethinyl estradiol; levomefolate calcium. There are ten 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 Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Bayer HlthcareSAFYRALdrospirenone; ethinyl estradiol; levomefolate calciumTABLET;ORAL022574-001Dec 16, 2010ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Bayer HlthcareSAFYRALdrospirenone; ethinyl estradiol; levomefolate calciumTABLET;ORAL022574-001Dec 16, 2010ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Bayer HlthcareSAFYRALdrospirenone; ethinyl estradiol; levomefolate calciumTABLET;ORAL022574-001Dec 16, 2010ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Bayer HlthcareSAFYRALdrospirenone; ethinyl estradiol; levomefolate calciumTABLET;ORAL022574-001Dec 16, 2010ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Paragraph IV (Patent) Challenges for SAFYRAL

Drugname Dosage Strength RLD Submissiondate
drospirenone and ethinyl estradiol and levomefolate calcium and levomefolate calciumTablets3 mg/0.03 mg/0.451 mg and 0.451 mgSafyral9/28/2012

Non-Orange Book Patents for Tradename: 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
7,569,557Compositions of estrogen-cyclodextrin complexes► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Tradename: SAFYRAL

Country Document Number Estimated Expiration
Russian Federation2265605► Subscribe
Slovenia1353700► Subscribe
Canada2756207► Subscribe
South Korea100774012► Subscribe
South Korea20070062964► Subscribe
Spain2374369► Subscribe
Switzerland693905► Subscribe
Spain2374371► Subscribe
South Korea20090120015► Subscribe
Hungary229423► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

Export unavailable in trial.
Subscribe for complete access.

Supplementary Protection Certificates for Tradename: SAFYRAL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0022France► SubscribePRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
C/GB04/032United Kingdom► SubscribePRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Teva
Citi
Chinese Patent Office
McKinsey
Deloitte
Boehringer Ingelheim
Daiichi Sankyo
Covington
Harvard Business School
AstraZeneca

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:

botpot