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Serving 500+ biopharmaceutical companies globally:

Chinese Patent Office
UBS
Julphar
Cantor Fitzgerald
Accenture
Healthtrust
US Department of Justice
McKesson
Dow
Daiichi Sankyo

Generated: September 23, 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 two hundred and eighty-one patent family members in forty-four countries.

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

Summary for Generic Name: ezetimibe

Tradenames:4
Patents:4
Applicants:13
NDAs:14
Drug Master File Entries: see list24
Suppliers / Packagers: see list19
Bulk Api Vendors: see list61
Clinical Trials: see list244
Patent Applications: see list5,375
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:ezetimibe at DailyMed

Pharmacology for Ingredient: ezetimibe

Tentative approvals for EZETIMIBE

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe10MGTABLET;ORAL
► Subscribe► Subscribe10MG; 80MGTABLET; ORAL
► Subscribe► 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
Watson Labs Inc
EZETIMIBE AND SIMVASTATIN
ezetimibe; simvastatin
TABLET;ORAL202968-004Apr 26, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Watson Labs Inc
EZETIMIBE AND SIMVASTATIN
ezetimibe; simvastatin
TABLET;ORAL202968-003Apr 26, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Ohm Labs Inc
EZETIMIBE
ezetimibe
TABLET;ORAL207311-001Jun 12, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Impax Labs Inc
EZETIMIBE AND SIMVASTATIN
ezetimibe; simvastatin
TABLET;ORAL201890-001Apr 26, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Msd Intl
VYTORIN
ezetimibe; simvastatin
TABLET;ORAL021687-002Jul 23, 2004ABRXYesNo► Subscribe► Subscribe ► Subscribe
Dr Reddys Labs Sa
EZETIMIBE AND SIMVASTATIN
ezetimibe; simvastatin
TABLET;ORAL200909-004Apr 26, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Watson Labs Inc
EZETIMIBE
ezetimibe
TABLET;ORAL200831-001Jun 12, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Zydus Pharms Usa Inc
EZETIMIBE
ezetimibe
TABLET;ORAL204331-001Jun 12, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Dr Reddys Labs Sa
EZETIMIBE AND SIMVASTATIN
ezetimibe; simvastatin
TABLET;ORAL200909-001Apr 26, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Aurobindo Pharma Ltd
EZETIMIBE
ezetimibe
TABLET;ORAL209838-001Aug 25, 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
7,056,906Combinations of hormone replacement therapy composition(s) and sterol absorption inhibitor(s) and treatments for vascular conditions in post-menopausal women► Subscribe
7,053,080Methods and therapeutic combinations for the treatment of obesity using sterol absorption inhibitors► Subscribe
6,982,251Substituted 2-azetidinones useful as hypocholesterolemic agents► Subscribe
5,767,115 Hydroxy-substituted azetidinone compounds useful as hypocholesterolemic agents► Subscribe
5,846,966 Combinations of hydroxy-substituted azetidinone compounds and HMG CoA Reductase Inhibitors► Subscribe
6,864,385 Process for the preparation of 4-haloalkylnicotinonitriles► Subscribe
5,631,365 Hydroxy-substituted azetidinone compounds useful as hypocholesterolemic agents► Subscribe
7,071,181Methods and therapeutic combinations for the treatment of diabetes using sterol absorption inhibitors► 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
South Africa200305694► Subscribe
Australia2002241903► Subscribe
Slovenia1413331► Subscribe
Spain2286233► Subscribe
Japan2004525091► Subscribe
Hong Kong1056735► Subscribe
South Korea20080067717► Subscribe
Luxembourg91160► Subscribe
China1915429► Subscribe
Slovakia288217► 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
C0028France► SubscribePRODUCT NAME: EZETIMIBE; NAT. REGISTRATION NO/DATE: NL28237 20030611; FIRST REGISTRATION: DE - 54486.00.00 A 54489.00.00 20021017
90018-0Sweden► SubscribePRODUCT NAME: EZETIMIB
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
C014/2003Ireland► SubscribeSPC014/2003: 20050803, EXPIRES: 20171016
2005 00003Denmark► Subscribe
/2005Austria► SubscribePRODUCT NAME: EZETIMIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON KOMBINIERT MIT SIMVASTATIN; NAT. REGISTRATION NO/DATE: 1-25673 - 1-25676 20041228; FIRST REGISTRATION: DE 58874.00.00 - 58874.03.00; 58878.00.00 - 20040402
0172Netherlands► Subscribe300172, 20140914, EXPIRES: 20190401
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
C0040France► SubscribePRODUCT NAME: EZETIMIBE; SIMVASTATINE; NAT. REGISTRATION NO/DATE: NL 31849 20050728; FIRST REGISTRATION: DE - 58 878 00 00 20040402
0132Netherlands► Subscribe300132, 20140914, EXPIRES: 20171016
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Merck
Accenture
Argus Health
Cerilliant
Baxter
Harvard Business School
Farmers Insurance
Boehringer Ingelheim
Cipla
US Department of Justice

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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