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Generated: May 22, 2019

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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 freedom to operate?

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

Dienogest; estradiol valerate has eighty-six patent family members in thirty-eight countries.

There are seven drug master file entries for dienogest; estradiol valerate. Two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for DIENOGEST; ESTRADIOL VALERATE
Generic filers with tentative approvals for DIENOGEST; ESTRADIOL VALERATE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign UpN/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/ATABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

US Patents and Regulatory Information for DIENOGEST; ESTRADIOL VALERATE

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 DIENOGEST; ESTRADIOL VALERATE

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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Supplementary Protection Certificates for DIENOGEST; ESTRADIOL VALERATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0770388 SPC/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
0770388 2009/012 Ireland ➤ Sign Up PRODUCT NAME: QLAIRA-ESTRADIOL VALERATE/DIENOGEST; NAT REGISTRATION NO/DATE: PA1410/58/1 20090109; FIRST REGISTRATION NO/DATE: BE327792 20081103
0770388 09C0018 France ➤ Sign Up PRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 20081103
0770388 9/2009 Austria ➤ Sign Up PRODUCT NAME: KOMBINATION AUS ESTRADIOLVALERAT UND DIENOGEST; NAT. REGISTRATION NO/DATE: 1-28003 20090203; FIRST REGISTRATION: BE BE 327792 20081103
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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