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Dienogest; estradiol valerate - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for dienogest; estradiol valerate?

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

This ingredient has ninety-two patent family members in forty-two countries.

There are seven drug master file entries for dienogest; estradiol valerate. Three suppliers are listed for this compound.

Summary for Generic Name: dienogest; estradiol valerate

Tradenames:2
Patents:5
Applicants:2
NDAs:2
Drug Master File Entries: see list7
Suppliers / Packagers: see list3
Clinical Trials: see list266
Drug Prices:see low prices
DailyMed Link:dienogest; estradiol valerate at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date 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, 2010RXYesYes8,071,577► SubscribeY ► 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
Watson Labs Inc
ESTRADIOL VALERATE AND DIENOGEST
dienogest; estradiol valerate
TABLET;ORAL202349-001May 6, 2016RXNoNo► Subscribe► 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
Slovenia1937274► Subscribe
Norway20065292► Subscribe
Japan2007533681► Subscribe
Germany502005006837► Subscribe
Cyprus1111406► 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
C0018France► SubscribePRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 20081103
0770388/01Switzerland► SubscribeFORMER REPRESENTATIVE: BOHEST AG, CH
09/012Ireland► SubscribePRODUCT NAME: QLAIRA-ESTRADIOL VALERATE/DIENOGEST; NAT REGISTRATION NO/DATE: PA1410/58/1 20090109; FIRST REGISTRATION NO/DATE: BE327792 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
2009Austria► SubscribePRODUCT NAME: KOMBINATION AUS ESTRADIOLVALERAT UND DIENOGEST; NAT. REGISTRATION NO/DATE: 1-28003 20090203; FIRST REGISTRATION: BE BE 327792 20081103
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