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Last Updated: March 19, 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
>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 021687-002 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 021687-004 Jul 23, 2004 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for VYTORIN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 SZ 26/2005 Austria ⤷  Try a Trial
0720599 SPC/GB05/010 United Kingdom ⤷  Try a Trial PRODUCT 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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