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Profile for Tradename: BEYAZ

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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 three 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. Two suppliers are 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 list4
Formulation / Manufacturing:see details

Clinical Trials for: BEYAZ

Low Dose OC Therapy in Women With Polycystic Ovary Syndrome (PCOS): Impact of BMI on Hyperandrogenism
Status: Completed Condition: Polycystic Ovary Syndrome

Study of Treatment With the Combination of Drospirenone Plus Ethinyl Estradiol Plus Levomefolate Calcium in Mexican Women Seeking Contraception
Status: Completed Condition: Contraception

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
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>
Bayer Hlthcare
BEYAZ
drospirenone; ethinyl estradiol; levomefolate calcium
TABLET;ORAL022532-001Sep 24, 2010RXNo6,441,168<disabled>Y<disabled>
Bayer Hlthcare
BEYAZ
drospirenone; ethinyl estradiol; levomefolate calcium
TABLET;ORAL022532-001Sep 24, 2010RXNo8,617,597<disabled>Y<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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International Patent Family for Tradename: BEYAZ

Country Document Number Publication Date
Japan2013047279Mar 07, 2013
MontenegroP38108Feb 10, 2011
Hungary0001560Apr 28, 2001
Canada2756207Jun 27, 2002
Canada2194979Jan 06, 2009
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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