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Serving leading biopharmaceutical companies globally:

Novartis
Baxter
UBS
Chinese Patent Office
Fish and Richardson
Merck
Medtronic
Colorcon
QuintilesIMS
Cerilliant

Generated: November 20, 2017

DrugPatentWatch Database Preview

Ezetimibe - Generic Drug Details

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What are the generic drug sources for ezetimibe and what is the scope of ezetimibe freedom to operate?

Ezetimibe
is the generic ingredient in four branded drugs marketed by Amneal Pharms Co, Ohm Labs Inc, Teva Pharms Usa, Sandoz Inc, Watson Labs Inc, Zydus Pharms Usa Inc, Apotex Inc, Aurobindo Pharma Ltd, Msd Intl Gmbh, Glenmark Pharms Ltd, Dr Reddys Labs Sa, Msd Intl, and Impax Labs Inc, and is included in fourteen NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ezetimibe has three hundred and six patent family members in forty-four countries and twenty supplementary protection certificates in nine countries.

There are twenty-four drug master file entries for ezetimibe. Twenty-one suppliers are listed for this compound. There are five tentative approvals for this compound.

Pharmacology for ezetimibe

Medical Subject Heading (MeSH) Categories for ezetimibe

Tentative approvals for EZETIMIBE

Applicant Application No. Strength Dosage Form
u► Subscribe10MGTABLET;ORAL
u► Subscribe10MG; 80MGTABLET; ORAL
u► Subscribe10MG; 40MGTABLET; ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Msd Intl
VYTORIN
ezetimibe; simvastatin
TABLET;ORAL021687-001Jul 23, 2004ABRXYesNo► Subscribe► Subscribe ► Subscribe
Msd Intl
VYTORIN
ezetimibe; simvastatin
TABLET;ORAL021687-002Jul 23, 2004ABRXYesNo► Subscribe► Subscribe ► Subscribe
Watson Labs Inc
EZETIMIBE
ezetimibe
TABLET;ORAL200831-001Jun 12, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Msd Intl
VYTORIN
ezetimibe; simvastatin
TABLET;ORAL021687-001Jul 23, 2004ABRXYesNo► Subscribe► Subscribe ► Subscribe
Dr Reddys Labs Sa
EZETIMIBE AND SIMVASTATIN
ezetimibe; simvastatin
TABLET;ORAL200909-002Apr 26, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Teva Pharms Usa
EZETIMIBE
ezetimibe
TABLET;ORAL078724-001Jun 12, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Impax Labs Inc
EZETIMIBE AND SIMVASTATIN
ezetimibe; simvastatin
TABLET;ORAL201890-003Apr 26, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Watson Labs Inc
EZETIMIBE AND SIMVASTATIN
ezetimibe; simvastatin
TABLET;ORAL202968-003Apr 26, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Dr Reddys Labs Sa
EZETIMIBE AND SIMVASTATIN
ezetimibe; simvastatin
TABLET;ORAL200909-004Apr 26, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Dr Reddys Labs Sa
EZETIMIBE AND SIMVASTATIN
ezetimibe; simvastatin
TABLET;ORAL200909-003Apr 26, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: ezetimibe

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Msd Intl Gmbh
ZETIA
ezetimibe
TABLET;ORAL021445-001Oct 25, 2002► Subscribe► Subscribe
Msd Intl Gmbh
ZETIA
ezetimibe
TABLET;ORAL021445-001Oct 25, 2002► Subscribe► Subscribe
Msd Intl Gmbh
ZETIA
ezetimibe
TABLET;ORAL021445-001Oct 25, 2002► Subscribe► Subscribe
Msd Intl Gmbh
ZETIA
ezetimibe
TABLET;ORAL021445-001Oct 25, 2002► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: ezetimibe

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,541,640 Process for the preparation of 4-haloalkylnicotinonitriles► Subscribe
7,053,080Methods and therapeutic combinations for the treatment of obesity using sterol absorption inhibitors► Subscribe
7,056,906Combinations of hormone replacement therapy composition(s) and sterol absorption inhibitor(s) and treatments for vascular conditions in post-menopausal women► Subscribe
5,767,115 Hydroxy-substituted azetidinone compounds useful as hypocholesterolemic agents► Subscribe
5,631,365 Hydroxy-substituted azetidinone compounds useful as hypocholesterolemic agents► Subscribe
5,846,966 Combinations of hydroxy-substituted azetidinone compounds and HMG CoA Reductase Inhibitors► Subscribe
7,071,181Methods and therapeutic combinations for the treatment of diabetes using sterol absorption inhibitors► Subscribe
6,982,251Substituted 2-azetidinones useful as hypocholesterolemic agents► Subscribe
6,864,385 Process for the preparation of 4-haloalkylnicotinonitriles► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: ezetimibe

Country Document Number Estimated Expiration
Russian Federation2003122520► Subscribe
MexicoPA03006725► Subscribe
Australia2002247019► Subscribe
Israel191417► Subscribe
Portugal1413331► Subscribe
Spain2287826► Subscribe
Australia2002335770► Subscribe
Poland363237► Subscribe
Denmark1363668► Subscribe
South Africa200304586► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: EZETIMIBE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C014/2003Ireland► SubscribeSPC014/2003: 20050803, EXPIRES: 20171016
00172Netherlands► SubscribePRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN SIMVASTATINE; NAT. REGISTRATION NO/DATE: RVG 30927RVG 30928RVG 30929RVG 30930 2004221122; FIRST REGISTRATION: 58874.00.0058874.01.0058874.02.0058874.03.0058878.00.0058878.01.0058878.02.0058878.03.0058866.00.0058866.01.0058866.02.0058866.03.0058870.00.0058870.01.0058870.02.0058870.03.00 2004020402
545Luxembourg► SubscribePRODUCT NAME: EZETIMIBE EN COMBINAISON AVEC ATORVASTATINE OU LEURS SELS PHARMACEUTIQUEMENT ACCEPTEES, Y COMPRIS ATORVASTATINE SOUS FORME D'ATORVASTATINE CALCIQUE TRIHYDRATEE; FIRST REGISTRATION: 20140910
C0028France► SubscribePRODUCT NAME: EZETIMIBE; NAT. REGISTRATION NO/DATE: NL28237 20030611; FIRST REGISTRATION: DE - 54486.00.00 A 54489.00.00 20021017
2014 00050Denmark► SubscribePRODUCT NAME: EZETIMIBE AND ATORVASTATIN OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING ATORVASTATIN AS ATORVASTATIN CALCIUM TRIHYDRATE; REG. NO/DATE: DE/H/3895-3898/001-004/DC 20140910
00132Netherlands► SubscribePRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; NATL REGISTRATION: RVG 28626 20030418; FIRST REGISTRATION: DE 54486.00.00, 54487.00.00, 54488.00.00, 54489.00.00 20021017
0172Netherlands► Subscribe300172, 20140914, EXPIRES: 20190401
2014 00048Denmark► SubscribePRODUCT NAME: KOMBINATION AF ROSUVASTATIN OG EZETIMIBE ELLER FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER ROSUVASTATIN SOM ZINK; NAT. REG. NO/DATE: 52921, 52922, 52923 20140820; FIRST REG. NO/DATE: NO 13-9663, 13-9664, 13-9665 20140724
0720599/02Switzerland► SubscribeFORMER OWNER: SCHERING CORPORATION, US
544Luxembourg► SubscribePRODUCT NAME: EZETIMIBE EN COMBINAISON AVEC ROSUVASTATINE OU LEURS SELS PHARMACEUTIQUEMENT ACCEPTEES, Y COMPRIS ROSUVASTATINE SOUD FORME DE SEL DE ZINC; FIRST REGISTRATION DATE: 20140724
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Covington
McKinsey
Julphar
UBS
US Department of Justice
Johnson and Johnson
Chinese Patent Office
Argus Health
Fuji
AstraZeneca

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.

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ISSN: 2162-2639

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