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NATAZIA Drug Profile

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Natazia is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from three suppliers. There are four patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in NATAZIA is dienogest; estradiol valerate. There are seven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the dienogest; estradiol valerate profile page.

Summary for Tradename: NATAZIA

Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: see list3
Formulation / Manufacturing:see details
Drug Prices: :see details
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, 2010RXYes6,133,251► subscribeYY ► subscribe
Bayer Hlthcare
NATAZIA
dienogest; estradiol valerate
TABLET;ORAL022252-001May 6, 2010RXYes8,071,577► subscribeY ► subscribe
Bayer Hlthcare
NATAZIA
dienogest; estradiol valerate
TABLET;ORAL022252-001May 6, 2010RXYes6,884,793► subscribeYY ► subscribe
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Expired Patents for Tradename: NATAZIA

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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Paragraph IV activity for: NATAZIA

Drugname Dosage Strength RLD Submissiondate
estradiol valerate and dienogestTablets3 mg; 2 mg/2 mg; 2 mg/3 mg; 1 mgNatazia10/22/2010

International Patent Family for Tradename: NATAZIA

Country Document Number Estimated Expiration
Dominican RepublicP2006000221► subscribe
Japan3020880► subscribe
Peru05552007► 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: NATAZIA

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
2009Austria► subscribePRODUCT NAME: KOMBINATION AUS ESTRADIOLVALERAT UND DIENOGEST; NAT. REGISTRATION NO/DATE: 1-28003 20090203; FIRST REGISTRATION: BE BE 327792 20081103
643Luxembourg► subscribe91643, EXPIRES: 20211022
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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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