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BEYAZ Drug Profile

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Beyaz is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from one supplier. There are five patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and seven patent family members in thirty-nine countries.

The generic ingredient in BEYAZ is drospirenone; ethinyl estradiol; levomefolate calcium. There are ten drug master file entries for this compound. One supplier is listed for this compound. There is one tentative approval for this compound. Additional details are available on the drospirenone; ethinyl estradiol; levomefolate calcium profile page.

Summary for Tradename: BEYAZ

Patents:5
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Formulation / Manufacturing:see details

Clinical Trials for: BEYAZ

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare
BEYAZ
drospirenone; ethinyl estradiol; levomefolate calcium
TABLET;ORAL022532-001Sep 24, 2010RXNo7,163,931<disabled> <disabled>
Bayer Hlthcare
BEYAZ
drospirenone; ethinyl estradiol; levomefolate calcium
TABLET;ORAL022532-001Sep 24, 2010RXNo6,958,326<disabled>Y <disabled>
Bayer Hlthcare
BEYAZ
drospirenone; ethinyl estradiol; levomefolate calcium
TABLET;ORAL022532-001Sep 24, 2010RXNo5,798,338<disabled>Y <disabled>
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Expired Patents for Tradename: BEYAZ

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare
BEYAZ
drospirenone; ethinyl estradiol; levomefolate calcium
TABLET;ORAL022532-001Sep 24, 2010RE37838<disabled>
Bayer Hlthcare
BEYAZ
drospirenone; ethinyl estradiol; levomefolate calcium
TABLET;ORAL022532-001Sep 24, 20105,798,338<disabled>
Bayer Hlthcare
BEYAZ
drospirenone; ethinyl estradiol; levomefolate calcium
TABLET;ORAL022532-001Sep 24, 2010RE38253<disabled>
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Paragraph IV activity for: BEYAZ

Drugname Dosage Strength RLD Submissiondate
drospirenone and ethinyl estradiol and levomefolate calcium and levomefolate calciumTablets3 mg/0.02 mg/0.451 mg and 0.451 mgBeyaz11/13/2012
drospirenone and ethinyl estradiol and levomefolateTablets3 mg/0.02 mg/0.451 mg and 0.451 mgBeyaz11/21/2011

Non-Orange Book Patents for Tradename: BEYAZ

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<disabled in preview>
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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: BEYAZ

Country Document Number Estimated Expiration
Denmark2189459<disabled in preview>
Spain2218561<disabled in preview>
Australia782641<disabled in preview>
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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: BEYAZ

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0022France<disabled>PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
C0001France<disabled>PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
2006 00038Denmark<disabled>PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
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