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Serving leading biopharmaceutical companies globally:

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Generated: January 19, 2018

DrugPatentWatch Database Preview

Dienogest; estradiol valerate - Generic Drug Details

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What are the generic sources for dienogest; estradiol valerate and what is the scope of dienogest; estradiol valerate patent protection?

Dienogest; estradiol valerate
is the generic ingredient in one branded drug marketed by Bayer Hlthcare and is included in one NDA. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Dienogest; estradiol valerate has one hundred and eight patent family members in forty-three countries.

There are seven drug master file entries for dienogest; estradiol valerate. Three suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for dienogest; estradiol valerate
International Patents:108
US Patents:4
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 7
Suppliers / Packagers: 3
Clinical Trials: 721
Drug Prices:see low prices
DailyMed Link:dienogest; estradiol valerate at DailyMed
Tentative approvals for DIENOGEST; ESTRADIOL VALERATE
Applicant Application No. Strength Dosage Form
➤ Subscribe➤ SubscribeN/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/ATABLET;ORAL

US Patents and Regulatory Information for dienogest; estradiol valerate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare NATAZIA dienogest; estradiol valerate TABLET;ORAL 022252-001 May 6, 2010 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Bayer Hlthcare NATAZIA dienogest; estradiol valerate TABLET;ORAL 022252-001 May 6, 2010 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Bayer Hlthcare NATAZIA dienogest; estradiol valerate TABLET;ORAL 022252-001 May 6, 2010 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Bayer Hlthcare NATAZIA dienogest; estradiol valerate TABLET;ORAL 022252-001 May 6, 2010 RX Yes Yes ➤ 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 dienogest; estradiol valerate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare NATAZIA dienogest; estradiol valerate TABLET;ORAL 022252-001 May 6, 2010 ➤ Subscribe ➤ Subscribe
Bayer Hlthcare NATAZIA dienogest; estradiol valerate TABLET;ORAL 022252-001 May 6, 2010 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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International Patents for dienogest; estradiol valerate

Supplementary Protection Certificates for dienogest; estradiol valerate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
643 Luxembourg ➤ Subscribe 91643, EXPIRES: 20211022
2009004 Lithuania ➤ Subscribe PRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103
0770388/01 Switzerland ➤ Subscribe FORMER REPRESENTATIVE: BOHEST AG, CH
C/GB09/026 United Kingdom ➤ Subscribe PRODUCT NAME: ESTRADIOL AND COMBINATIONS OF ESTRADIOL AND DIENOGEST, PREFERABLY ESTRADIOL VALERATE AND COMBINATIONS OF ESTRADIOL VALERATE AND DIENOGEST; REGISTERED: BE BE 327792 20081103; UK PL 00010/0576-0001 20081208
09/012 Ireland ➤ Subscribe PRODUCT NAME: QLAIRA-ESTRADIOL VALERATE/DIENOGEST; NAT REGISTRATION NO/DATE: PA1410/58/1 20090109; FIRST REGISTRATION NO/DATE: BE327792 20081103
7 Finland ➤ Subscribe
2009 00016 Denmark ➤ Subscribe
C0018 France ➤ Subscribe PRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 20081103
2009004,C0770388 Lithuania ➤ Subscribe PRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103
2009 Austria ➤ Subscribe PRODUCT NAME: KOMBINATION AUS ESTRADIOLVALERAT UND DIENOGEST; NAT. REGISTRATION NO/DATE: 1-28003 20090203; FIRST REGISTRATION: BE BE 327792 20081103
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

US Army
Baxter
Cantor Fitzgerald
Moodys
Farmers Insurance
Federal Trade Commission
Daiichi Sankyo
US Department of Justice
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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