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

International Patents:	90
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Clinical Trials:	14
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for dienogest; estradiol valerate
DailyMed Link:	dienogest; estradiol valerate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for dienogest; estradiol valerate

Generic Entry Date for dienogest; estradiol valerate^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

Sponsor	Phase
Laboratorios Andromaco S.A.	Phase 1
Kocaeli Derince Education and Research Hospital	Phase 4
Bagcilar Training and Research Hospital	Phase 4

See all dienogest; estradiol valerate clinical trials

Generic filers with tentative approvals for DIENOGEST; ESTRADIOL VALERATE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A	TABLET;ORAL

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

Anatomical Therapeutic Chemical (ATC) Classes for dienogest; estradiol valerate

G03CA	Natural and semisynthetic estrogens, plain
G03C	ESTROGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

G03DB	Pregnadien derivatives
G03D	PROGESTOGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

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

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Glossary

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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

Expired US Patents for dienogest; estradiol valerate

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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

International Patents for dienogest; estradiol valerate

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Country	Patent Number	Title	Estimated Expiration
Germany	102004019743	Mehrphasenpräparat zur Kontrazeption auf der Basis eines natürlichen Estrogens	⤷ Sign Up
Germany	502005009904		⤷ Sign Up
Japan	4908399		⤷ Sign Up
Malaysia	143669	MULTIPHASE PRODUCT FOR CONTRACEPTION BASED ON A NATURAL OESTROGEN	⤷ Sign Up
New Zealand	550417	Multi-phase contraceptive preparation based on a natural estrogen	⤷ Sign Up
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	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for dienogest; estradiol valerate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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	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	09C0018	France	⤷ Sign Up	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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