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SAFYRAL Drug Profile

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Which patents cover Safyral, and what substitute generic drugs 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 ninety-six patent family members in thirty-nine 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.

Summary for Tradename: SAFYRAL

Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Bulk Api Vendors: see list1
Patent Applications: see list1
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:SAFYRAL at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare
SAFYRAL
drospirenone; ethinyl estradiol; levomefolate calcium
TABLET;ORAL022574-001Dec 16, 2010RXYesYes7,163,931► Subscribe ► Subscribe
Bayer Hlthcare
SAFYRAL
drospirenone; ethinyl estradiol; levomefolate calcium
TABLET;ORAL022574-001Dec 16, 2010RXYesYes6,441,168► SubscribeY ► Subscribe
Bayer Hlthcare
SAFYRAL
drospirenone; ethinyl estradiol; levomefolate calcium
TABLET;ORAL022574-001Dec 16, 2010RXYesYes8,617,597► SubscribeY ► Subscribe
Bayer Hlthcare
SAFYRAL
drospirenone; ethinyl estradiol; levomefolate calcium
TABLET;ORAL022574-001Dec 16, 2010RXYesYes6,958,326► SubscribeY ► Subscribe
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Expired Patents for Tradename: SAFYRAL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare
SAFYRAL
drospirenone; ethinyl estradiol; levomefolate calcium
TABLET;ORAL022574-001Dec 16, 20105,798,338► Subscribe
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Paragraph IV activity 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
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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.

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International Patent Family for Tradename: SAFYRAL

Country Document Number Estimated Expiration
South Korea101275372► Subscribe
Eurasian Patent Organization200600884► Subscribe
South Korea20070062964► Subscribe
European Patent Office1353700► Subscribe
Australia782641► Subscribe
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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.

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Supplementary Protection Certificates for Tradename: SAFYRAL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
C0022France► SubscribePRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
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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.

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