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Last Updated: November 14, 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 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-seven patent family members in thirty-nine 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
Recent Clinical Trials for DIENOGEST; ESTRADIOL VALERATE

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SponsorPhase
Suleymaniye Birth And Women's Health Education And Research HospitalPhase 4
Bagcilar Training and Research HospitalPhase 4
Kocaeli Derince Education and Research HospitalPhase 4

See all DIENOGEST; ESTRADIOL VALERATE clinical trials

Recent Litigation for DIENOGEST; ESTRADIOL VALERATE

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District Court Litigation
Case NameDate
Bayer Pharma AG v. Watson Laboratories Inc.2012-12-18
Bayer Pharma AG v. Lupin Ltd.2012-11-28

See all DIENOGEST; ESTRADIOL VALERATE litigation

Generic filers with tentative approvals for DIENOGEST; ESTRADIOL VALERATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start TrialN/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.

Paragraph IV (Patent) Challenges for DIENOGEST; ESTRADIOL VALERATE
Tradename Dosage Ingredient NDA Submissiondate
NATAZIA TABLET;ORAL dienogest; estradiol valerate 022252 2010-10-22

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   Start Trial   Start Trial Y   Start Trial
Bayer Hlthcare NATAZIA dienogest; estradiol valerate TABLET;ORAL 022252-001 May 6, 2010 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

Supplementary Protection Certificates for DIENOGEST; ESTRADIOL VALERATE

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

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