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Serving 500+ biopharmaceutical companies globally:

Citi
Boehringer Ingelheim
Cerilliant
Julphar
Dow
McKesson
Fish and Richardson
Harvard Business School
Covington
Healthtrust

Generated: July 24, 2017

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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, Msd Intl Gmbh, Glenmark Pharms Ltd, Dr Reddys Labs Sa, Msd Intl, and Impax Labs Inc, and is included in thirteen NDAs. There are five 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. Sixteen suppliers are listed for this compound. There are five tentative approvals for this compound.

Summary for Generic Name: ezetimibe

Tradenames:4
Patents:5
Applicants:12
NDAs:13
Drug Master File Entries: see list24
Suppliers / Packagers: see list16
Bulk Api Vendors: see list61
Clinical Trials: see list242
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
Msd Intl
VYTORIN
ezetimibe; simvastatin
TABLET;ORAL021687-001Jul 23, 2004ABRXYesNo► Subscribe► Subscribe ► Subscribe
Sandoz Inc
EZETIMIBE
ezetimibe
TABLET;ORAL203931-001Jun 12, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Impax Labs Inc
EZETIMIBE AND SIMVASTATIN
ezetimibe; simvastatin
TABLET;ORAL201890-004Apr 26, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Msd Intl Gmbh
ZETIA
ezetimibe
TABLET;ORAL021445-001Oct 25, 2002ABRXYesYes► Subscribe► SubscribeY► Subscribe
Zydus Pharms Usa Inc
EZETIMIBE
ezetimibe
TABLET;ORAL204331-001Jun 12, 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
7,071,181Methods and therapeutic combinations for the treatment of diabetes using sterol absorption inhibitors► Subscribe
6,541,640 Process for the preparation of 4-haloalkylnicotinonitriles► Subscribe
6,982,251Substituted 2-azetidinones useful as hypocholesterolemic agents► Subscribe
5,846,966 Combinations of hydroxy-substituted azetidinone compounds and HMG CoA Reductase 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
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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
EcuadorSP034659► Subscribe
South Korea20040025890► Subscribe
China1736982► Subscribe
New Zealand531060► Subscribe
World Intellectual Property Organization (WIPO)02058732► 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
C/GB03/023United Kingdom► SubscribePRODUCT NAME: EZETIMIBE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: PL 19945/0001-0002 20021017; FIRST REGISTRATION: DE 54486.00.00, 54488.00.00, 54487.00.00, 54489.00.00 20021017
C001/2005Ireland► SubscribeSPC001/2005: 20050803, EXPIRES: 20190401
2005 00003Denmark► Subscribe
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
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:

US Department of Justice
Moodys
Federal Trade Commission
AstraZeneca
Fish and Richardson
UBS
Daiichi Sankyo
Colorcon
McKesson
Mallinckrodt

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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