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Serving 500+ biopharmaceutical companies globally:

Moodys
Medtronic
Federal Trade Commission
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Colorcon
Julphar
Queensland Health
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Generated: June 27, 2017

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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 ninety-four 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 Generic Name: dienogest; estradiol valerate

Tradenames:1
Patents:4
Applicants:1
NDAs:1
Drug Master File Entries: see list7
Suppliers / Packagers: see list3
Clinical Trials: see list693
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
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;ORAL022252-001May 6, 2010RXYesYes8,153,616► Subscribe ► Subscribe
Bayer Hlthcare
NATAZIA
dienogest; estradiol valerate
TABLET;ORAL022252-001May 6, 2010RXYesYes6,884,793► SubscribeYY ► Subscribe
Bayer Hlthcare
NATAZIA
dienogest; estradiol valerate
TABLET;ORAL022252-001May 6, 2010RXYesYes6,133,251► SubscribeYY ► Subscribe
Bayer Hlthcare
NATAZIA
dienogest; estradiol valerate
TABLET;ORAL022252-001May 6, 2010RXYesYes8,071,577► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: dienogest; estradiol valerate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare
NATAZIA
dienogest; estradiol valerate
TABLET;ORAL022252-001May 6, 20106,133,251► Subscribe
Bayer Hlthcare
NATAZIA
dienogest; estradiol valerate
TABLET;ORAL022252-001May 6, 20106,884,793► Subscribe
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International Patent Family for Ingredient: dienogest; estradiol valerate

Country Document Number Estimated Expiration
Germany19540253► Subscribe
Argentina084229► Subscribe
Japan4908399► Subscribe
Malaysia143669► Subscribe
Guatemala200500093► Subscribe
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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: DIENOGEST; ESTRADIOL VALERATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2009004Lithuania► SubscribePRODUCT 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
C/GB09/026United Kingdom► SubscribePRODUCT 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
09/012Ireland► SubscribePRODUCT NAME: QLAIRA-ESTRADIOL VALERATE/DIENOGEST; NAT REGISTRATION NO/DATE: PA1410/58/1 20090109; FIRST REGISTRATION NO/DATE: BE327792 20081103
2009 00016Denmark► Subscribe
643Luxembourg► Subscribe91643, EXPIRES: 20211022
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

US Department of Justice
AstraZeneca
Moodys
McKesson
Healthtrust
Boehringer Ingelheim
QuintilesIMS
Medtronic
UBS
Colorcon

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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