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Last Updated: March 28, 2024

VYTORIN Drug Patent Profile


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When do Vytorin patents expire, 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
Organon VYTORIN ezetimibe; simvastatin TABLET;ORAL 021687-003 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
Organon VYTORIN ezetimibe; simvastatin TABLET;ORAL 021687-003 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
Japan H08509989 ⤷  Try a Trial
Israel 62044 POLYHYDRONAPHTHYLETHYL TETRAHYDRO-2H-PYRAN-2-ONE DERIVATIVES AND HYDROXY ACIDS AND ESTERS THEREOF,THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM ⤷  Try a Trial
European Patent Office 0720599 COMPOSES D'AZETIDINONE HYDROXY-SUBSTITUES EFFICACES EN TANT QU'AGENTS HYPOCHOLESTEROLEMIQUES (HYDROXY-SUBSTITUTED AZETIDINONE COMPOUNDS USEFUL AS HYPOCHOLESTEROLEMIC AGENTS) ⤷  Try a Trial
Taiwan 200906388 Pharmaceutical formulation ⤷  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 122004000026 Germany ⤷  Try a Trial PRODUCT NAME: EZETIMIB ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON IN KOMBINATION MIT SIMVASTATIN; NAT. REGISTRATION NO/DATE: 58866.00.00 58866.01.00 58866.02.00 58866.03.00 58870.00.00 58870.01.00 58870.02.00 58870.03.00 58874.00.00 58874.01.00 58874.02.00 58874.03.00 58878.00.00 58878.01.00 58878.02.00 58878.03.00 20040402 FIRST REGISTRATION: DE 58866.00.00 - 58866.03.00 58870.00.00 - 58870.03.00 58874.00.00 - 58874.03.00 58878.00.00 - 58878.03.00 20040402
0720599 300688 Netherlands ⤷  Try a Trial PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ROSUVASTATINE; NATIONAL REGISTRATION NO/DATE: RVG114002-004 20140811; FIRST REGISTRATION: NO 13-9663 - 9665 20140724
0720599 2003/014 Ireland ⤷  Try a Trial PRODUCT NAME: EZETIMIBE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NAT REGISTRATION NO/DATE: 1091/1/1 00040127; FIRST REGISTRATION NO/DATE: EU: DE 54489.00.00 54486.00.00 54488.00.00 54487.00.00 20021017; PAEDIATRIC INVESTIGATION PLAN: P/0061/2012
0720599 CR 2014 00050 Denmark ⤷  Try a Trial PRODUCT 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
>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.