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Ezetimibe; simvastatin - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for ezetimibe; simvastatin?

Ezetimibe; simvastatin is the generic ingredient in one branded drug marketed by Msd Intl and is included in one NDA. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has forty-eight patent family members in thirty countries.

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

Summary for Generic Name: ezetimibe; simvastatin

Tradenames:1
Patents:2
Applicants:1
NDAs:1
Drug Master File Entries: see list24
Suppliers / Packagers: see list5
Clinical Trials: see list197
Drug Prices:see low prices
DailyMed Link:ezetimibe; simvastatin at DailyMed

Pharmacology for Ingredient: ezetimibe; simvastatin

Tentative approvals for EZETIMIBE; SIMVASTATIN

Applicant Application No. Form Dosage
► Subscribe► SubscribeTABLET; ORAL10MG; 10MG
► Subscribe► SubscribeTABLET; ORAL10MG; 20MG
► Subscribe► SubscribeTABLET; ORAL10MG; 40MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Msd Intl
VYTORIN
ezetimibe; simvastatin
TABLET;ORAL021687-004Jul 23, 2004RXYesYesRE37721*PED► Subscribe ► Subscribe
Msd Intl
VYTORIN
ezetimibe; simvastatin
TABLET;ORAL021687-002Jul 23, 2004RXYesNoRE42461*PED► Subscribe ► Subscribe
Msd Intl
VYTORIN
ezetimibe; simvastatin
TABLET;ORAL021687-002Jul 23, 2004RXYesNoRE37721*PED► Subscribe ► Subscribe
Msd Intl
VYTORIN
ezetimibe; simvastatin
TABLET;ORAL021687-001Jul 23, 2004RXYesNoRE37721*PED► Subscribe ► Subscribe
Msd Intl
VYTORIN
ezetimibe; simvastatin
TABLET;ORAL021687-003Jul 23, 2004RXYesNoRE42461*PED► 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, 20044,444,784► Subscribe
Msd Intl
VYTORIN
ezetimibe; simvastatin
TABLET;ORAL021687-004Jul 23, 20044,444,784► Subscribe
Msd Intl
VYTORIN
ezetimibe; simvastatin
TABLET;ORAL021687-003Jul 23, 20044,444,784► Subscribe
Msd Intl
VYTORIN
ezetimibe; simvastatin
TABLET;ORAL021687-003Jul 23, 20045,846,966*PED► Subscribe
Msd Intl
VYTORIN
ezetimibe; simvastatin
TABLET;ORAL021687-004Jul 23, 20045,846,966*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
5,846,966 Combinations of hydroxy-substituted azetidinone compounds and HMG CoA Reductase Inhibitors► Subscribe
5,767,115 Hydroxy-substituted azetidinone compounds useful as hypocholesterolemic agents► Subscribe
5,631,365 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
China1050830► Subscribe
Norway961133► Subscribe
Denmark0720599► Subscribe
JapanH08509989► Subscribe
Israel110956► 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
C/GB05/010United Kingdom► SubscribePRODUCT NAME: EZETIMIBE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH SIMVASTATIN; REGISTERED: DE 58874.00.00 20040402; DE 58874.01.00 20040402; DE 58874.02.00 20040402; DE 58874.03.00 20040402; DE 58878.00.00 20040402; DE 58878.01.00 20040402; DE 58878.02.00 20040402; DE 58878.03.00 20040402; DE 58866.00.00 20040402; DE 58866.01.00 20040402; DE 58866.02.00 20040402; DE 58866.03.00 20040402; DE 58870.00.00 20040402; DE 58870.01.00 20040402; DE 58870.02.00 20040402; DE 58870.03.00 20040402; UK PL 19945/0003 20041118; UK PL 19945/0004 20041118; UK PL 19945/0005 20041118; UK PL 19945/0006 20041118; UK PL 19945/0007 20041118; UK PL 19945/0008 20041118; UK PL 19945/0009 200411
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
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
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
0720599/02Switzerland► SubscribeFORMER OWNER: SCHERING CORPORATION, US
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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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