NATAZIA Drug Patent Profile
✉ Email this page to a colleague
Which patents cover Natazia, and when can generic versions of Natazia launch?
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 |
| 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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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.
Anatomical Therapeutic Chemical (ATC) Classes for NATAZIA
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
| 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
| 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: 73734
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.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| South Africa | 200609594 | MULTI-PHASE CONTRACEPTIVE PREPARATION BASED ON A ESTROGEN | ⤷ Try a Trial |
| Denmark | 1937274 | ⤷ Try a Trial | |
| Slovenia | 1740163 | ⤷ Try a Trial | |
| 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) | ⤷ Try a Trial |
| Portugal | 1740163 | ⤷ Try a Trial | |
| El Salvador | 2006002090 | PREPARADO POLIFASICO A BASE DE UN ESTRÓGENO NATURAL PARA LA CONTRACEPCION REF. P-SV-77.951/MSU | ⤷ Try a Trial |
| Taiwan | I328453 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for NATAZIA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 | CA 2009 00016 | Denmark | ⤷ Try a Trial | |
| 0770388 | PA2009004,C0770388 | 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 |
| 0770388 | 09C0018 | France | ⤷ Try a Trial | PRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 20081103 |
| 0770388 | 91643 | Luxembourg | ⤷ Try a Trial | 91643, EXPIRES: 20211022 |
| 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 | C00770388/01 | Switzerland | ⤷ Try a Trial | FORMER REPRESENTATIVE: BOHEST AG, CH |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2024 - 2025
NCE-1 Patent Challenge Dates 2024 - 2025
Trigger-based marketing for the life sciences
Get DrugPatentWatch Business Intelligence Reports at Amazon.com
DrugChatter - AI-based answers to questions about drugs
RxJam - HIPAA-ready chat for life sciences
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
See Primary Research Papers Citing DrugPatentWatch
Follow DrugPatentWatch:
