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Serving leading biopharmaceutical companies globally:

McKesson
US Army
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Queensland Health
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Generated: December 11, 2017

DrugPatentWatch Database Preview

VYTORIN Drug Profile

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Which patents cover 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.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Msd IntlVYTORINezetimibe; simvastatinTABLET;ORAL021687-001Jul 23, 2004ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Msd IntlVYTORINezetimibe; simvastatinTABLET;ORAL021687-004Jul 23, 2004ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Msd IntlVYTORINezetimibe; simvastatinTABLET;ORAL021687-002Jul 23, 2004ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Msd IntlVYTORINezetimibe; simvastatinTABLET;ORAL021687-004Jul 23, 2004ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Msd IntlVYTORINezetimibe; simvastatinTABLET;ORAL021687-001Jul 23, 2004ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Msd IntlVYTORINezetimibe; simvastatinTABLET;ORAL021687-002Jul 23, 2004ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Msd IntlVYTORINezetimibe; simvastatinTABLET;ORAL021687-003Jul 23, 2004ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Msd IntlVYTORINezetimibe; simvastatinTABLET;ORAL021687-003Jul 23, 2004ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
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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
Luxembourg91160► Subscribe
New Zealand274041► Subscribe
Hungary221185► Subscribe
Austria180249► Subscribe
Poland182617► Subscribe
HungaryT73852► Subscribe
Norway961133► Subscribe
Czech Republic288891► Subscribe
South Africa9407086► 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
C0028France► SubscribePRODUCT NAME: EZETIMIBE; NAT. REGISTRATION NO/DATE: NL28237 20030611; FIRST REGISTRATION: DE - 54486.00.00 A 54489.00.00 20021017
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
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
0720599/02Switzerland► SubscribeFORMER OWNER: SCHERING CORPORATION, US
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
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
00132Netherlands► SubscribePRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; NATL REGISTRATION: RVG 28626 20030418; FIRST REGISTRATION: DE 54486.00.00, 54487.00.00, 54488.00.00, 54489.00.00 20021017
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Serving leading biopharmaceutical companies globally:

Medtronic
Express Scripts
Teva
Dow
Fuji
Citi
Julphar
US Army
Cipla
Accenture

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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