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Dienogest; estradiol valerate - Generic Drug Details

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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:4
Applicants:2
NDAs:2
Drug Master File Entries: see list7
Suppliers / Packaging: see list3
Formulation / Manufacturing:see details
Drug Prices:see low prices
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare
NATAZIA
dienogest; estradiol valerate
TABLET;ORAL022252-001May 6, 2010RXYes8,153,616► subscribe ► subscribe
Bayer Hlthcare
NATAZIA
dienogest; estradiol valerate
TABLET;ORAL022252-001May 6, 2010RXYes6,133,251► subscribeYY ► subscribe
Bayer Hlthcare
NATAZIA
dienogest; estradiol valerate
TABLET;ORAL022252-001May 6, 2010RXYes6,884,793► subscribeYY ► subscribe
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Expired Orange Book Patents for Generic Ingredient: dienogest; estradiol valerate

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

Country Document Number Estimated Expiration
Uruguay28863► subscribe
Poland186339► subscribe
Poland1937274► 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
09/012Ireland► subscribePRODUCT NAME: QLAIRA-ESTRADIOL VALERATE/DIENOGEST; NAT REGISTRATION NO/DATE: PA1410/58/1 20090109; FIRST REGISTRATION NO/DATE: BE327792 20081103
0770388/01Switzerland► subscribeFORMER REPRESENTATIVE: BOHEST AG, CH
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
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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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