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NATAZIA Drug Patent Profile

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 ninety patent family members in thirty-nine countries.

The generic ingredient in NATAZIA is dienogest; estradiol valerate. There are seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the dienogest; estradiol valerate profile page.

DrugPatentWatch^® Generic Entry Outlook for Natazia

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 13, 2026. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (dienogest; estradiol valerate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for NATAZIA

International Patents:	90
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	71
Drug Prices:	Drug price information for NATAZIA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NATAZIA
What excipients (inactive ingredients) are in NATAZIA?	NATAZIA excipients list
DailyMed Link:	NATAZIA at DailyMed

See drug prices for NATAZIA

See drug sales revenues for NATAZIA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for NATAZIA

NDA:

022252

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.

Paragraph IV (Patent) Challenges for NATAZIA

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 NATAZIA

NATAZIA is protected by two US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting 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
Bayer Hlthcare	NATAZIA	dienogest; estradiol valerate	TABLET;ORAL	022252-001	May 6, 2010		RX	Yes	Yes			Y

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
Bayer Hlthcare	NATAZIA	dienogest; estradiol valerate	TABLET;ORAL	022252-001	May 6, 2010

International Patents for NATAZIA

See the table below for patents covering NATAZIA around the world.

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)
Argentina	056694	USO DE VALERATO DE ESTRADIOL EN COMBINACION CON DIENOGEST PARA LA TERAPIA ORAL DE LA HEMORRAGIA UTERINA DISFUNCIONAL UNIDA CON UNA ANTICONCEPCION ORAL
Taiwan	I351960
China	1946383	Multi-phase contraceptive preparation based on a natural estrogen
Montenegro	01056	UPOTREBA ESTRADIOLVALERATA I DIENOGESTA ZA ORALNO LIJEČENJE DISFUNKCIONALNOG UTERINOG KRVARENJA U KONTRACEPCIJSKOM METODU (USE OF ESTRADIOLVALERATE AND DIENOGEST FOR ORAL TREATMENT OF DYSFUNCTIONAL UTERINE BLEEDING IN A CONTRACEPTIVE METHOD)
Denmark	0770388
Ukraine	83915	МНОГОФАЗНЫЙ ПРЕПАРАТ ДЛЯ КОНТРАЦЕПЦИИ НА ОСНОВЕ НАТУРАЛЬНОГО ЭСТРОГЕНА;БАГАТОФАЗНИЙ ПРЕПАРАТ ДЛЯ КОНТРАЦЕПЦІЇ НА ОСНОВІ НАТУРАЛЬНОГО ЕСТРОГЕНУ (MULTI-PHASE CONTRACEPTIVE PREPARATION BASED ON A NATURAL ESTROGEN)

Supplementary Protection Certificates for NATAZIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0770388	CA 2009 00016	Denmark
0770388	9/2009	Austria		PRODUCT NAME: KOMBINATION AUS ESTRADIOLVALERAT UND DIENOGEST; NAT. REGISTRATION NO/DATE: 1-28003 20090203; FIRST REGISTRATION: BE BE 327792 20081103
0770388	2009/012	Ireland		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		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	427	Finland
0770388	PA2009004,C0770388	Lithuania		PRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103
0770388	09C0018	France		PRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 20081103