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Serving 500+ biopharmaceutical companies globally:

Cerilliant
Daiichi Sankyo
Moodys
Citi
Express Scripts
Merck
Argus Health
US Army
Boehringer Ingelheim
AstraZeneca

Generated: June 26, 2017

DrugPatentWatch Database Preview

Ezetimibe; simvastatin - Generic Drug Details

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What are the generic sources for ezetimibe; simvastatin and what is the scope of ezetimibe; simvastatin patent protection?

Ezetimibe; simvastatin
is the generic ingredient in two branded drugs marketed by Dr Reddys Labs Sa, Watson Labs Inc, Msd Intl, and Impax Labs Inc, and is included in four NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ezetimibe; simvastatin has forty-eight patent family members in thirty countries.

There are twenty-four drug master file entries for ezetimibe; simvastatin. Nine suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: ezetimibe; simvastatin

Tradenames:2
Patents:3
Applicants:4
NDAs:4
Drug Master File Entries: see list24
Suppliers / Packagers: see list9
Clinical Trials: see list580
Drug Prices:see low prices
DailyMed Link:ezetimibe; simvastatin at DailyMed

Pharmacology for Ingredient: ezetimibe; simvastatin

Tentative approvals for EZETIMIBE; SIMVASTATIN

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe10MG; 10MGTABLET; 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;ORAL021687-002Jul 23, 2004ABRXYesNoRE37721*PED► Subscribe ► Subscribe
Dr Reddys Labs Sa
EZETIMIBE AND SIMVASTATIN
ezetimibe; simvastatin
TABLET;ORAL200909-003Apr 26, 2017ABRXNoNo► Subscribe► Subscribe
Dr Reddys Labs Sa
EZETIMIBE AND SIMVASTATIN
ezetimibe; simvastatin
TABLET;ORAL200909-001Apr 26, 2017ABRXNoNo► Subscribe► Subscribe
Msd Intl
VYTORIN
ezetimibe; simvastatin
TABLET;ORAL021687-001Jul 23, 2004ABRXYesNoRE42461*PED► Subscribe ► Subscribe
Impax Labs Inc
EZETIMIBE AND SIMVASTATIN
ezetimibe; simvastatin
TABLET;ORAL201890-002Apr 26, 2017ABRXNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: ezetimibe; simvastatin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Msd Intl
VYTORIN
ezetimibe; simvastatin
TABLET;ORAL021687-001Jul 23, 2004RE42461*PED► Subscribe
Msd Intl
VYTORIN
ezetimibe; simvastatin
TABLET;ORAL021687-002Jul 23, 2004RE37721*PED► Subscribe
Msd Intl
VYTORIN
ezetimibe; simvastatin
TABLET;ORAL021687-003Jul 23, 2004RE42461*PED► Subscribe
Msd Intl
VYTORIN
ezetimibe; simvastatin
TABLET;ORAL021687-001Jul 23, 20044,444,784► Subscribe
Msd Intl
VYTORIN
ezetimibe; simvastatin
TABLET;ORAL021687-004Jul 23, 2004RE37721*PED► Subscribe
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Non-Orange Book Patents for Generic Ingredient: ezetimibe; simvastatin

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
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
5,767,115 Hydroxy-substituted azetidinone compounds useful as hypocholesterolemic agents► 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; simvastatin

Country Document Number Estimated Expiration
Netherlands300132► Subscribe
Poland313589► Subscribe
Luxembourg92544► Subscribe
Poland182617► Subscribe
Norway961133► 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; SIMVASTATIN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0040France► SubscribePRODUCT NAME: EZETIMIBE; SIMVASTATINE; NAT. REGISTRATION NO/DATE: NL 31849 20050728; FIRST REGISTRATION: DE - 58 878 00 00 20040402
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
0132Netherlands► Subscribe300132, 20140914, EXPIRES: 20171016
160Luxembourg► Subscribe91160, EXPIRES: 20190914
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
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Citi
Mallinckrodt
Medtronic
Harvard Business School
US Department of Justice
Novartis
Baxter
AstraZeneca
US Army
Fuji

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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