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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Daiichi Sankyo
Deloitte
Cantor Fitzgerald
Accenture
Teva
AstraZeneca
Chubb
Fuji
McKesson

Generated: October 17, 2017

DrugPatentWatch Database Preview

VYTORIN Drug Profile

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What is the patent landscape for Vytorin, and when can generic versions of Vytorin launch?

Vytorin is a drug marketed by Msd Intl and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has forty-nine patent family members in thirty countries and twenty supplementary protection certificates in nine countries.

The generic ingredient in VYTORIN is ezetimibe; simvastatin. There are twenty-four drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the ezetimibe; simvastatin profile page.

Summary for Tradename: VYTORIN

US Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list5
Clinical Trials: see list37
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:VYTORIN at DailyMed
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;ORAL021687-004Jul 23, 2004ABRXYesYes► Subscribe► Subscribe ► Subscribe
Msd Intl
VYTORIN
ezetimibe; simvastatin
TABLET;ORAL021687-002Jul 23, 2004ABRXYesNo► Subscribe► Subscribe ► Subscribe
Msd Intl
VYTORIN
ezetimibe; simvastatin
TABLET;ORAL021687-004Jul 23, 2004ABRXYesYes► Subscribe► Subscribe ► Subscribe
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
Msd Intl
VYTORIN
ezetimibe; simvastatin
TABLET;ORAL021687-003Jul 23, 2004ABRXYesNo► Subscribe► Subscribe ► Subscribe
Msd Intl
VYTORIN
ezetimibe; simvastatin
TABLET;ORAL021687-003Jul 23, 2004ABRXYesNo► Subscribe► Subscribe ► Subscribe
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Expired Patents for Tradename: VYTORIN

Paragraph IV (Patent) Challenges for VYTORIN

Drugname Dosage Strength RLD Submissiondate
ezetimibe and simvastatinTablets10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mgVytorin7/27/2009

Non-Orange Book Patents for Tradename: VYTORIN

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 Tradename: VYTORIN

Country Document Number Estimated Expiration
European Patent Office0720599► Subscribe
Norway2003007► Subscribe
Netherlands300172► Subscribe
Russian Federation2138480► Subscribe
Australia681445► Subscribe
Georgia, Republic ofP20043149► Subscribe
Finland961300► Subscribe
Norway305902► Subscribe
China1050830► Subscribe
Greece3030312► 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: VYTORIN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0720599/02Switzerland► SubscribeFORMER OWNER: SCHERING CORPORATION, US
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
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
90018-0Sweden► SubscribePRODUCT NAME: EZETIMIB
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
2005 00003Denmark► Subscribe
0172Netherlands► Subscribe300172, 20140914, EXPIRES: 20190401
/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
0132Netherlands► Subscribe300132, 20140914, EXPIRES: 20171016
160Luxembourg► Subscribe91160, EXPIRES: 20190914
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Serving leading biopharmaceutical companies globally:

Medtronic
Argus Health
Boehringer Ingelheim
US Army
Mallinckrodt
Cerilliant
Deloitte
Chubb
Fuji
Chinese Patent Office

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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