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Last Updated: March 19, 2024

Dienogest; estradiol valerate - Generic Drug Details


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What are the generic drug 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 ninety patent family members in thirty-nine countries.

Two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for dienogest; estradiol valerate
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for dienogest; estradiol valerate
Generic Entry Date for dienogest; estradiol valerate*:
Constraining patent/regulatory exclusivity:
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.

Recent Clinical Trials for dienogest; estradiol valerate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Laboratorios Andromaco S.A.Phase 1
Kocaeli Derince Education and Research HospitalPhase 4
Bagcilar Training and Research HospitalPhase 4

See all dienogest; estradiol valerate clinical trials

Generic filers with tentative approvals for DIENOGEST; ESTRADIOL VALERATE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a 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 Strength NDA ANDAs Submitted Submissiondate
NATAZIA Tablets dienogest; estradiol valerate 3 mg;2 mg/2 mg; 2 mg/3 mg and 1 mg 022252 1 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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Bayer Hlthcare NATAZIA dienogest; estradiol valerate TABLET;ORAL 022252-001 May 6, 2010 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 ⤷  Try a Trial ⤷  Try a Trial
Bayer Hlthcare NATAZIA dienogest; estradiol valerate TABLET;ORAL 022252-001 May 6, 2010 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for dienogest; estradiol valerate

Country Patent Number Title Estimated Expiration
Canada 2623024 UTILISATION DE VALERATE D'ESTRADIOL OU D'ESTRADIOL COMBINE ADU DIENOGEST POUR TRAITER PAR VOIE ORALE LA MENOMETRORRAGIE SOUS FORME UNITAIRE AVEC UN CONTRACEPTIF ORAL (USE OF ESTRADIOL VALERATE OR ESTRADIOL COMBINED WITH DIENOGEST FOR THE ORAL THERAPY OF DYSFUNCTIONAL UTERINE BLEEDING IN THE FORM OF ORAL CONTRACEPTIVES) ⤷  Try a Trial
Poland 1787649 ⤷  Try a Trial
Portugal 1933843 ⤷  Try a Trial
Uruguay 29861 USO DE VALERATO DE ESTRADIOL EN COMBINACIÓN CON DIENOGEST PARA LA TERAPIA ORAL DE LA HEMORRAGIA UTERINA DISFUNCIONAL UNIDA CON UNA ANTICONCEPCION ORAL ⤷  Try a Trial
New Zealand 550417 Multi-phase contraceptive preparation based on a natural estrogen ⤷  Try a Trial
Japan 2013047269 USE OF ESTRADIOL VALERATE OR ESTRADIOL COMBINED WITH DIENOGEST FOR ORAL THERAPY OF DYSFUNCTIONAL UTERINE BLEEDING IN FORM OF ORAL CONTRACEPTIVE ⤷  Try a Trial
Hong Kong 1099701 MULTI-PHASE CONTRACEPTIVE PREPARATION BASED ON A NATURAL ESTROGEN ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for dienogest; estradiol valerate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0770388 9/2009 Austria ⤷  Try a Trial PRODUCT NAME: KOMBINATION AUS ESTRADIOLVALERAT UND DIENOGEST; NAT. REGISTRATION NO/DATE: 1-28003 20090203; FIRST REGISTRATION: BE BE 327792 20081103
0770388 SPC/GB09/026 United Kingdom ⤷  Try a Trial 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 09C0018 France ⤷  Try a Trial PRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 20081103
0770388 2009/012 Ireland ⤷  Try a Trial PRODUCT NAME: QLAIRA-ESTRADIOL VALERATE/DIENOGEST; NAT REGISTRATION NO/DATE: PA1410/58/1 20090109; FIRST REGISTRATION NO/DATE: BE327792 20081103
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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