Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Mallinckrodt
AstraZeneca
Dow
Moodys
Johnson and Johnson

Last Updated: October 18, 2019

DrugPatentWatch Database Preview

NATAZIA Drug Profile

See Plans and Pricing

« Back to Dashboard

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 eighty-seven 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.

Drug patent expirations by year for NATAZIA
Drug Prices for NATAZIA

See drug prices for NATAZIA

Drug Sales Revenue Trends for NATAZIA

See drug sales revenues for NATAZIA

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.

Recent Litigation for NATAZIA

Identify potential future generic entrants

District Court Litigation
Case NameDate
Bayer Pharma AG v. Watson Laboratories Inc.2012-12-18
Bayer Pharma AG v. Lupin Ltd.2012-11-28

See all NATAZIA litigation

Synonyms for NATAZIA
(17-hydroxy-3-oxoestra-4,9-dien-17beta-yl)acetonitrile
[(17?)-17-Hydroxy-3-oxoestra-4,9-dien-17-yl]acetonitrile
[(17beta)-17-hydroxy-3-oxoestra-4,9-dien-17-yl]acetonitrile
17 alpha-cyanomethyl-17 beta-hydroxy-13 beta-methylgona-4,9-dien-3-one
17 alpha-cyanomethyl-17 beta-hydroxyestra-4,9(10)-diene-3-one
17-alpha-Cyanomethyl-17-beta-hydroxy-estra-4,9(10)-dien-3-one
17-alpha-Cyanomethyl-17-beta-hydroxyestra-4,9(10)-diene-3-one
17-cyanomethyl-17-hydroxy-estra-4,9-dien-3-one
17-Hydroxy-3-oxo-19-nor-17alpha-pregna-4,9-diene-21-nitrile
17-Hydroxy-3-oxo-19-norpregna-4,9-diene-21-nitrile
17alpha-17-Hydroxy-3-oxo-19-norpregna-4,9-diene-21-nitrile
17alpha-Cyanomethyl-17beta-hydroxyestra-4,9(10)-dien-3-one
19-Norpregna-4,9-diene-21-nitrile, 17-hydroxy-3-oxo-, (17-alpha)-
19-Norpregna-4,9-diene-21-nitrile, 17-hydroxy-3-oxo-, (17alpha)-
2-((8S,13S,14S,17R)-17-hydroxy-13-methyl-3-oxo-2,3,6,7,8,11,12,13,14,15,16,17-dodecahydro-1H-cyclopenta[a]phenanthren-17-yl)acetonitrile
2-[(8S,13S,14S,17R)-17-hydroxy-13-methyl-3-oxo-1,2,6,7,8,11,12,14,15,16-decahydrocyclopenta[a]phenanthren-17-yl]acetonitrile
46M3EV8HHE
65928-58-7
928D587
AB01566807_01
AC-2166
AC1L2ALM
ACN-037291
AKOS015840152
AKOS015896680
AN-5182
API0000534
AZFLJNIPTRTECV-FUMNGEBKSA-N
BAY 86-5258
BAY86-5258
BCP22681
BRD-K50853363-001-02-3
CHEBI:70708
CHEMBL1201864
CS-1782
D03799
D5230
DB09123
Dienogest
Dienogest (JAN/USAN/INN)
Dienogest [INN]
Dienogest [USAN:INN:BAN]
Dienogest for system suitability, EuropePharmacopoeia (EP) Reference Standard
Dienogest, >=98% (HPLC)
Dienogest, EuropePharmacopoeia (EP) Reference Standard
Dienogestrel
Dienogestril
Dienogestum
Dienogestum [Latin]
Dinagest
Endometrion
Endometrion (TN)
FT-0666715
GTPL7654
HY-B0084
I06-2188
LS-97337
M 18575
M-18575
MJR-35
MolPort-006-393-664
s1251
SCHEMBL37293
SH-T00660AA
SR-01000942230
SR-01000942230-1
STS 557
STS-557
UNII-46M3EV8HHE
Visanne
X4651
ZINC4215629
ZK 37659
ZK-37659

US Patents and Regulatory Information for 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   Start Trial   Start Trial   Start Trial
Bayer Hlthcare NATAZIA dienogest; estradiol valerate TABLET;ORAL 022252-001 May 6, 2010 RX Yes Yes   Start Trial   Start Trial Y   Start 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   Start Trial   Start Trial
Bayer Hlthcare NATAZIA dienogest; estradiol valerate TABLET;ORAL 022252-001 May 6, 2010   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for NATAZIA
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 3 mg; 2 mg/2 mg; 2 mg/3 mg; 1 mg ➤ Subscribe   Start Trial

Supplementary Protection Certificates for NATAZIA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0770388 9/2009 Austria   Start Trial PRODUCT NAME: KOMBINATION AUS ESTRADIOLVALERAT UND DIENOGEST; NAT. REGISTRATION NO/DATE: 1-28003 20090203; FIRST REGISTRATION: BE BE 327792 20081103
0770388 2009/012 Ireland   Start Trial PRODUCT NAME: QLAIRA-ESTRADIOL VALERATE/DIENOGEST; NAT REGISTRATION NO/DATE: PA1410/58/1 20090109; FIRST REGISTRATION NO/DATE: BE327792 20081103
0770388 09C0018 France   Start Trial PRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 20081103
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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

Serving leading biopharmaceutical companies globally:

Dow
Medtronic
Johnson and Johnson
AstraZeneca
Colorcon
Merck

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 verifification 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.