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Serving leading biopharmaceutical companies globally:

US Department of Justice
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Covington
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Generated: December 18, 2017

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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, Impax Labs Inc, Watson Labs Inc, and Msd Intl, and is included in four NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ezetimibe; simvastatin has forty-nine patent family members in thirty countries and twenty supplementary protection certificates in nine 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 ezetimibe; simvastatin

Tentative approvals for EZETIMIBE; SIMVASTATIN

Applicant Application No. Strength Dosage Form
u► Subscribe10MG; 10MGTABLET; ORAL
u► Subscribe10MG; 80MGTABLET; ORAL
u► 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 IntlVYTORINezetimibe; simvastatinTABLET;ORAL021687-003Jul 23, 2004ABRXYesNo► Subscribe► SubscribeY► Subscribe
Msd IntlVYTORINezetimibe; simvastatinTABLET;ORAL021687-004Jul 23, 2004ABRXYesYes► Subscribe► SubscribeY► Subscribe
Watson Labs IncEZETIMIBE AND SIMVASTATINezetimibe; simvastatinTABLET;ORAL202968-002Apr 26, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Dr Reddys Labs SaEZETIMIBE AND SIMVASTATINezetimibe; simvastatinTABLET;ORAL200909-003Apr 26, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Dr Reddys Labs SaEZETIMIBE AND SIMVASTATINezetimibe; simvastatinTABLET;ORAL200909-004Apr 26, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Msd IntlVYTORINezetimibe; simvastatinTABLET;ORAL021687-002Jul 23, 2004ABRXYesNo► Subscribe► SubscribeY► Subscribe
Msd IntlVYTORINezetimibe; simvastatinTABLET;ORAL021687-002Jul 23, 2004ABRXYesNo► Subscribe► SubscribeY► Subscribe
Watson Labs IncEZETIMIBE AND SIMVASTATINezetimibe; simvastatinTABLET;ORAL202968-003Apr 26, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Watson Labs IncEZETIMIBE AND SIMVASTATINezetimibe; simvastatinTABLET;ORAL202968-004Apr 26, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Msd IntlVYTORINezetimibe; simvastatinTABLET;ORAL021687-004Jul 23, 2004ABRXYesYes► Subscribe► SubscribeY► 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 IntlVYTORINezetimibe; simvastatinTABLET;ORAL021687-002Jul 23, 2004► Subscribe► Subscribe
Msd IntlVYTORINezetimibe; simvastatinTABLET;ORAL021687-003Jul 23, 2004► Subscribe► Subscribe
Msd IntlVYTORINezetimibe; simvastatinTABLET;ORAL021687-004Jul 23, 2004► Subscribe► Subscribe
Msd IntlVYTORINezetimibe; simvastatinTABLET;ORAL021687-002Jul 23, 2004► Subscribe► Subscribe
Msd IntlVYTORINezetimibe; simvastatinTABLET;ORAL021687-001Jul 23, 2004► Subscribe► Subscribe
Msd IntlVYTORINezetimibe; simvastatinTABLET;ORAL021687-003Jul 23, 2004► Subscribe► Subscribe
Msd IntlVYTORINezetimibe; simvastatinTABLET;ORAL021687-003Jul 23, 2004► Subscribe► Subscribe
Msd IntlVYTORINezetimibe; simvastatinTABLET;ORAL021687-004Jul 23, 2004► Subscribe► Subscribe
Msd IntlVYTORINezetimibe; simvastatinTABLET;ORAL021687-003Jul 23, 2004► Subscribe► Subscribe
Msd IntlVYTORINezetimibe; simvastatinTABLET;ORAL021687-004Jul 23, 2004► Subscribe► 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
Netherlands300172► Subscribe
Luxembourg92544► Subscribe
Denmark0720599► Subscribe
Norway305902► Subscribe
Czech Republic288891► Subscribe
New Zealand274041► Subscribe
Slovakia281067► Subscribe
Luxembourg91050► Subscribe
Poland313589► Subscribe
Australia7795294► 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
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
C0028France► SubscribePRODUCT NAME: EZETIMIBE; NAT. REGISTRATION NO/DATE: NL28237 20030611; FIRST REGISTRATION: DE - 54486.00.00 A 54489.00.00 20021017
160Luxembourg► Subscribe91160, EXPIRES: 20190914
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
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
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
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
C0040France► SubscribePRODUCT NAME: EZETIMIBE; SIMVASTATINE; NAT. REGISTRATION NO/DATE: NL 31849 20050728; FIRST REGISTRATION: DE - 58 878 00 00 20040402
00688Netherlands► SubscribePRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ROSUVASTATINE; NAT. REGISTRATION NO/DATE: RVG114002-004RVG 114008-010 2014110811; FIRST REGISTRATION: 13-9663 - 9665 20140724
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
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Serving leading biopharmaceutical companies globally:

AstraZeneca
Healthtrust
Mallinckrodt
Johnson and Johnson
Medtronic
Harvard Business School
Daiichi Sankyo
Accenture
Covington
McKinsey

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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