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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Julphar
Cipla
Harvard Business School
Healthtrust
McKesson
Accenture
AstraZeneca
Citi
Queensland Health

Generated: January 20, 2018

DrugPatentWatch Database Preview

BEYAZ Drug Profile

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When do Beyaz patents expire, and what generic alternatives are available?

Beyaz is a drug marketed by Bayer Hlthcare and is included in one NDA. There are four patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and twelve patent family members in forty countries.

The generic ingredient in BEYAZ 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 BEYAZ
International Patents:112
US Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: 2
Bulk Api Vendors: 1
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:BEYAZ at DailyMed
Drug patent expirations by year for BEYAZ

US Patents and Regulatory Information for BEYAZ

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare BEYAZ drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022532-001 Sep 24, 2010 AB RX No No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Bayer Hlthcare BEYAZ drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022532-001 Sep 24, 2010 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Bayer Hlthcare BEYAZ drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022532-001 Sep 24, 2010 AB RX No No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Bayer Hlthcare BEYAZ drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022532-001 Sep 24, 2010 AB RX No No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
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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Expired US Patents for BEYAZ

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare BEYAZ drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022532-001 Sep 24, 2010 ➤ Subscribe ➤ Subscribe
Bayer Hlthcare BEYAZ drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022532-001 Sep 24, 2010 ➤ Subscribe ➤ Subscribe
Bayer Hlthcare BEYAZ drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022532-001 Sep 24, 2010 ➤ Subscribe ➤ Subscribe
Bayer Hlthcare BEYAZ drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022532-001 Sep 24, 2010 ➤ Subscribe ➤ Subscribe
Bayer Hlthcare BEYAZ drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022532-001 Sep 24, 2010 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for BEYAZ
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 3 mg/0.02 mg/0.451 mg and 0.451 mg ➤ Subscribe 11/13/2012
➤ Subscribe Tablets 3 mg/0.02 mg/0.451 mg and 0.451 mg ➤ Subscribe 11/21/2011

Non-Orange Book US Patents for 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
7,569,557 Compositions of estrogen-cyclodextrin complexes ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for BEYAZ

Supplementary Protection Certificates for BEYAZ

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0022 France ➤ Subscribe 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 ➤ Subscribe 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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For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Queensland Health
Fuji
Citi
McKesson
Express Scripts
Moodys
Accenture
Julphar
Healthtrust

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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