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Last Updated: January 27, 2023

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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Drug patent expirations by year for NATAZIA
Drug Prices for NATAZIA

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Drug Sales Revenue Trends for NATAZIA

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DrugPatentWatch® Estimated Generic Entry Opportunity Date for NATAZIA
Generic Entry Date for NATAZIA*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of NATAZIA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HEAVY MENSTRUAL BLEEDING IN WOMEN WITHOUT ORGANIC PATHOLOGY WHO CHOOSE TO USE AN ORAL CONTRACEPTIVE AS THEIR METHOD OF CONTRACEPTION

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bayer Hlthcare NATAZIA dienogest; estradiol valerate TABLET;ORAL 022252-001 May 6, 2010 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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

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 See Plans and Pricing See Plans and Pricing
Bayer Hlthcare NATAZIA dienogest; estradiol valerate TABLET;ORAL 022252-001 May 6, 2010 See Plans and Pricing See Plans and Pricing
>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: See Plans and Pricing

Patent: 4229
Estimated Expiration: See Plans and Pricing

Australia

Patent: 05235418
Estimated Expiration: See Plans and Pricing

Austria

Patent: 3734
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0510005
Estimated Expiration: See Plans and Pricing

Canada

Patent: 61839
Estimated Expiration: See Plans and Pricing

China

Patent: 46383
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 95
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0100513
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 11292
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 40163
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 067000
Estimated Expiration: See Plans and Pricing

El Salvador

Patent: 06002090
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 0313
Estimated Expiration: See Plans and Pricing

Patent: 0601844
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 40163
Estimated Expiration: See Plans and Pricing

Germany

Patent: 2004019743
Estimated Expiration: See Plans and Pricing

Patent: 2005009904
Estimated Expiration: See Plans and Pricing

Guatemala

Patent: 0500093
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 99701
Estimated Expiration: See Plans and Pricing

Israel

Patent: 8510
Estimated Expiration: See Plans and Pricing

Japan

Patent: 08399
Estimated Expiration: See Plans and Pricing

Patent: 07533681
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 3669
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 06012213
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 183
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 0417
Estimated Expiration: See Plans and Pricing

Norway

Patent: 4098
Estimated Expiration: See Plans and Pricing

Patent: 065292
Estimated Expiration: See Plans and Pricing

Panama

Patent: 30901
Estimated Expiration: See Plans and Pricing

Peru

Patent: 060308
Estimated Expiration: See Plans and Pricing

Poland

Patent: 40163
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 40163
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 434
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 40163
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0609594
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 060134168
Estimated Expiration: See Plans and Pricing

Spain

Patent: 48038
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 51960
Estimated Expiration: See Plans and Pricing

Patent: 0534860
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 915
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 863
Estimated Expiration: See Plans and Pricing

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.

Country Patent Number Title Estimated Expiration
Russian Federation 2113849 КОМБИНИРОВАННЫЙ ПРЕПАРАТ ДЛЯ КОНТРАЦЕПЦИИ НА БАЗЕПРИРОДНЫХ ЭСТРОГЕНОВ (MIXED PREPARATION BASED ON NATURAL ESTROGENS FOR CONTRACEPTION) See Plans and Pricing
Spain 2360302 See Plans and Pricing
New Zealand 550417 Multi-phase contraceptive preparation based on a natural estrogen See Plans and Pricing
South Africa 200609594 MULTI-PHASE CONTRACEPTIVE PREPARATION BASED ON A ESTROGEN See Plans and Pricing
Denmark 1787649 See Plans and Pricing
Denmark 1933843 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for NATAZIA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0770388 C00770388/01 Switzerland See Plans and Pricing FORMER REPRESENTATIVE: BOHEST AG, CH
0770388 PA2009004 Lithuania See Plans and Pricing 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 91643 Luxembourg See Plans and Pricing 91643, EXPIRES: 20211022
0770388 09C0018 France See Plans and Pricing PRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 20081103
0770388 9/2009 Austria See Plans and Pricing PRODUCT NAME: KOMBINATION AUS ESTRADIOLVALERAT UND DIENOGEST; NAT. REGISTRATION NO/DATE: 1-28003 20090203; FIRST REGISTRATION: BE BE 327792 20081103
0770388 CA 2009 00016 Denmark See Plans and Pricing
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.