NATAZIA Drug Patent Profile

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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

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Summary for NATAZIA

International Patents:	90
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	71
Formulation / Manufacturing:	see details
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

Drug patent expirations by year for NATAZIA

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

Generic Entry Date for NATAZIA^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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.

Anatomical Therapeutic Chemical (ATC) Classes for NATAZIA

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 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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of NATAZIA is ⤷ Try a Trial.

This potential generic entry date is based on patent ⤷ Try a Trial.
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

Multi-phase contraceptive preparation based on a natural estrogen
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: PREVENTION OF PREGNANCY

Combination preparation for oral contraception and oral therapy of dysfunctional uterine bleeding containing estradiol valerate and dienogest and method of using same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HEAVY MENSTRUAL BLEEDING IN WOMEN WITHOUT ORGANIC PATHOLOGY WHO CHOOSE TO USE AN ORAL CONTRACEPTIVE AS THEIR METHOD OF CONTRACEPTION

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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	⤷ Try a Trial	⤷ Try a Trial				⤷ 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	Y			⤷ 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 NATAZIA

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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	⤷ 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 NATAZIA

When does loss-of-exclusivity occur for NATAZIA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 8830
Estimated Expiration: ⤷ Try a Trial

Patent: 4229
Estimated Expiration: ⤷ Try a Trial

Australia

Patent: 05235418
Estimated Expiration: ⤷ Try a Trial

Austria

Patent: 3734
Estimated Expiration: ⤷ Try a Trial

Brazil

Patent: 0510005
Estimated Expiration: ⤷ Try a Trial

Canada

Patent: 61839
Estimated Expiration: ⤷ Try a Trial

China

Patent: 46383
Estimated Expiration: ⤷ Try a Trial

Costa Rica

Patent: 95
Estimated Expiration: ⤷ Try a Trial

Croatia

Patent: 0100513
Estimated Expiration: ⤷ Try a Trial

Cyprus

Patent: 11292
Estimated Expiration: ⤷ Try a Trial

Denmark

Patent: 40163
Estimated Expiration: ⤷ Try a Trial

Ecuador

Patent: 067000
Estimated Expiration: ⤷ Try a Trial

El Salvador

Patent: 06002090
Estimated Expiration: ⤷ Try a Trial

Eurasian Patent Organization

Patent: 0313
Estimated Expiration: ⤷ Try a Trial

Patent: 0601844
Estimated Expiration: ⤷ Try a Trial

European Patent Office

Patent: 40163
Estimated Expiration: ⤷ Try a Trial

Germany

Patent: 2004019743
Estimated Expiration: ⤷ Try a Trial

Patent: 2005009904
Estimated Expiration: ⤷ Try a Trial

Guatemala

Patent: 0500093
Estimated Expiration: ⤷ Try a Trial

Hong Kong

Patent: 99701
Estimated Expiration: ⤷ Try a Trial

Israel

Patent: 8510
Estimated Expiration: ⤷ Try a Trial

Japan

Patent: 08399
Estimated Expiration: ⤷ Try a Trial

Patent: 07533681
Estimated Expiration: ⤷ Try a Trial

Malaysia

Patent: 3669
Estimated Expiration: ⤷ Try a Trial

Mexico

Patent: 06012213
Estimated Expiration: ⤷ Try a Trial

Montenegro

Patent: 183
Estimated Expiration: ⤷ Try a Trial

New Zealand

Patent: 0417
Estimated Expiration: ⤷ Try a Trial

Norway

Patent: 4098
Estimated Expiration: ⤷ Try a Trial

Patent: 065292
Estimated Expiration: ⤷ Try a Trial

Panama

Patent: 30901
Estimated Expiration: ⤷ Try a Trial

Peru

Patent: 060308
Estimated Expiration: ⤷ Try a Trial

Poland

Patent: 40163
Estimated Expiration: ⤷ Try a Trial

Portugal

Patent: 40163
Estimated Expiration: ⤷ Try a Trial

Serbia

Patent: 434
Estimated Expiration: ⤷ Try a Trial

Slovenia

Patent: 40163
Estimated Expiration: ⤷ Try a Trial

South Africa

Patent: 0609594
Estimated Expiration: ⤷ Try a Trial

South Korea

Patent: 060134168
Estimated Expiration: ⤷ Try a Trial

Spain

Patent: 48038
Estimated Expiration: ⤷ Try a Trial

Taiwan

Patent: 51960
Estimated Expiration: ⤷ Try a Trial

Patent: 0534860
Estimated Expiration: ⤷ Try a Trial

Ukraine

Patent: 915
Estimated Expiration: ⤷ Try a Trial

Uruguay

Patent: 863
Estimated Expiration: ⤷ Try a Trial

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

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

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Country	Patent Number	Title	Estimated Expiration
Japan	2009511526		⤷ Try a Trial
Spain	2360302		⤷ Try a Trial
Norway	20065292		⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2005102247		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for NATAZIA

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0770388	427	Finland	⤷ Try a Trial
0770388	C00770388/01	Switzerland	⤷ Try a Trial	FORMER REPRESENTATIVE: BOHEST AG, CH
0770388	PA2009004	Lithuania	⤷ Try a Trial	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Indicators of Generic Entry

Summary for NATAZIA

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

Anatomical Therapeutic Chemical (ATC) Classes for NATAZIA

Paragraph IV (Patent) Challenges for NATAZIA

Patents protecting NATAZIA

When does loss-of-exclusivity occur for NATAZIA?

Make Better Decisions: Try a trial or see plans & pricing

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