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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Julphar
Medtronic
McKesson
Citi
Queensland Health
Johnson and Johnson
Colorcon
Chinese Patent Office

Generated: April 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 thirteen 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. Four suppliers are listed for this compound. Additional details are available on the drospirenone; ethinyl estradiol; levomefolate calcium profile page.
Summary for BEYAZ
International Patents:113
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 ➤ Sign Up ➤ Sign Up ➤ Sign Up
Bayer Hlthcare BEYAZ drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022532-001 Sep 24, 2010 AB RX No No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Bayer Hlthcare BEYAZ drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022532-001 Sep 24, 2010 AB RX No No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Bayer Hlthcare BEYAZ drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022532-001 Sep 24, 2010 AB RX No No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
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 ➤ Sign Up ➤ Sign Up
Bayer Hlthcare BEYAZ drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022532-001 Sep 24, 2010 ➤ Sign Up ➤ Sign Up
Bayer Hlthcare BEYAZ drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022532-001 Sep 24, 2010 ➤ Sign Up ➤ Sign Up
Bayer Hlthcare BEYAZ drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022532-001 Sep 24, 2010 ➤ Sign Up ➤ Sign Up
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 2012-11-13
➤ Subscribe Tablets 3 mg/0.02 mg/0.451 mg and 0.451 mg ➤ Subscribe 2011-11-21

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 ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for BEYAZ

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB04/032 United Kingdom ➤ Sign Up PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310
C0022 France ➤ Sign Up PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Moodys
UBS
Colorcon
Julphar
Healthtrust
Harvard Business School
US Army
Dow

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