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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Questions you can ask:
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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 |
| 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
*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 ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bayer Hlthcare | NATAZIA | dienogest; estradiol valerate | TABLET;ORAL | 022252-001 | May 6, 2010 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 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 | ⤷ 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 NATAZIA
See the table below for patents covering NATAZIA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Spain | 2382459 | ⤷ Sign Up | |
| Cyprus | 1112775 | ⤷ Sign Up | |
| European Patent Office | 0770388 | Préparation contraceptive à plusieures phases, basée sur des oestrogènes naturels (Multiphase contraceptive preparation based on natural estrogens) | ⤷ Sign Up |
| Spain | 2116804 | ⤷ Sign Up | |
| Luxembourg | 91643 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for NATAZIA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0770388 | 09C0018 | France | ⤷ Sign Up | PRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 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 | PA2009004 | Lithuania | ⤷ Sign Up | 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 | C00770388/01 | Switzerland | ⤷ Sign Up | FORMER REPRESENTATIVE: BOHEST AG, CH |
| 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 |
| >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.
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