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Last Updated: March 29, 2024

VYTORIN Drug Patent Profile


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Which patents cover Vytorin, and what generic alternatives are available?

Vytorin is a drug marketed by Organon and is included in one NDA.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Vytorin

A generic version of VYTORIN was approved as ezetimibe; simvastatin by DR REDDYS LABS SA on April 26th, 2017.

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Paragraph IV (Patent) Challenges for VYTORIN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
VYTORIN Tablets ezetimibe; simvastatin 10 mg/10 mg 10 mg/20 mg 10 mg/40 mg 10 mg/80 mg 021687 1 2009-07-27

US Patents and Regulatory Information for VYTORIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Organon VYTORIN ezetimibe; simvastatin TABLET;ORAL 021687-001 Jul 23, 2004 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Organon VYTORIN ezetimibe; simvastatin TABLET;ORAL 021687-004 Jul 23, 2004 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Organon VYTORIN ezetimibe; simvastatin TABLET;ORAL 021687-002 Jul 23, 2004 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for VYTORIN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon VYTORIN ezetimibe; simvastatin TABLET;ORAL 021687-004 Jul 23, 2004 ⤷  Try a Trial ⤷  Try a Trial
Organon VYTORIN ezetimibe; simvastatin TABLET;ORAL 021687-003 Jul 23, 2004 ⤷  Try a Trial ⤷  Try a Trial
Organon VYTORIN ezetimibe; simvastatin TABLET;ORAL 021687-001 Jul 23, 2004 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for VYTORIN

See the table below for patents covering VYTORIN around the world.

Country Patent Number Title Estimated Expiration
Ecuador SP941119 COMPUESTOS ANTIHIPERCOLESTEROLEMICOS ⤷  Try a Trial
Japan S56122375 NOVEL ANTIHYPERCHOLESTEREMIC COMPOUND* ITS INTERMEDIATE AND ITS MANUFACTURE ⤷  Try a Trial
Serbia 20080072 SASTAVI KOJI SADRŽE INHIBITOR APSORPCIJE HOLESTEROLA, INHIBITOR HMG-COA REDUKTAZE I STABILIZUJUĆI AGENS (COMPOSITIONS COMPRISING A CHOLESTEROL ABSORBTION INHIBITOR, AND HMG-COA REDUCTASE INHIBITOR AND STABILIZING AGENT) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VYTORIN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0720599 05C0040 France ⤷  Try a Trial PRODUCT NAME: EZETIMIBE; SIMVASTATINE; NAT. REGISTRATION NO/DATE: NL 31849 20050728; FIRST REGISTRATION: DE - 58 878 00 00 20040402
0720599 C300132 Netherlands ⤷  Try a Trial PRODUCT 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
0720599 300689 Netherlands ⤷  Try a Trial PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ATORVASTATINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER ATORVASTATINE CALCIUM TRIHYDRATE; NATIONAL REGISTRATION NO/DATE: RVG114373-114376 20141027; FIRST REGISTRATION: FR 2014091200122 20140912
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.