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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Covington
McKinsey
McKesson
Express Scripts
Boehringer Ingelheim
Mallinckrodt
Daiichi Sankyo
Teva

Generated: July 15, 2018

DrugPatentWatch Database Preview

NATAZIA Drug Profile

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Which patents cover Natazia, and what generic alternatives are available?

Natazia is a drug marketed by Bayer Hlthcare and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has eighty-four patent family members in thirty-seven 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.
Drug patent expirations by year for NATAZIA
Generic Entry Opportunity Date for NATAZIA
Generic Entry Date for NATAZIA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage::
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for NATAZIA

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 ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Bayer Hlthcare NATAZIA dienogest; estradiol valerate TABLET;ORAL 022252-001 May 6, 2010 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
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 NATAZIA

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

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Paragraph IV (Patent) Challenges for NATAZIA
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 3 mg; 2 mg/2 mg; 2 mg/3 mg; 1 mg ➤ Subscribe ➤ Sign Up

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Supplementary Protection Certificates for NATAZIA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0018 France ➤ Sign Up PRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 20081103
2009 Austria ➤ Sign Up PRODUCT NAME: KOMBINATION AUS ESTRADIOLVALERAT UND DIENOGEST; NAT. REGISTRATION NO/DATE: 1-28003 20090203; FIRST REGISTRATION: BE BE 327792 20081103
09/012 Ireland ➤ Sign Up PRODUCT NAME: QLAIRA-ESTRADIOL VALERATE/DIENOGEST; NAT REGISTRATION NO/DATE: PA1410/58/1 20090109; FIRST REGISTRATION NO/DATE: BE327792 20081103
C/GB09/026 United Kingdom ➤ Sign Up 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Express Scripts
QuintilesIMS
Merck
Dow
Accenture
Colorcon
Farmers Insurance
Teva

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.