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Last Updated: November 28, 2021

DrugPatentWatch Database Preview

ZETIA Drug Patent Profile


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When do Zetia patents expire, and what generic alternatives are available?

Zetia is a drug marketed by Organon and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and thirty-five patent family members in thirty-eight countries.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Zetia

A generic version of ZETIA was approved as ezetimibe by GLENMARK PHARMS LTD on June 26th, 2015.

  Free Forever Trial

Paragraph IV (Patent) Challenges for ZETIA
Tradename Dosage Ingredient NDA Submissiondate
ZETIA TABLET;ORAL ezetimibe 021445 2006-10-25

US Patents and Regulatory Information for ZETIA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Organon ZETIA ezetimibe TABLET;ORAL 021445-001 Oct 25, 2002 AB RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Organon ZETIA ezetimibe TABLET;ORAL 021445-001 Oct 25, 2002 AB RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever 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 ZETIA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon ZETIA ezetimibe TABLET;ORAL 021445-001 Oct 25, 2002 ⤷  Free Forever Trial ⤷  Free Forever Trial
Organon ZETIA ezetimibe TABLET;ORAL 021445-001 Oct 25, 2002 ⤷  Free Forever Trial ⤷  Free Forever Trial
Organon ZETIA ezetimibe TABLET;ORAL 021445-001 Oct 25, 2002 ⤷  Free Forever Trial ⤷  Free Forever Trial
Organon ZETIA ezetimibe TABLET;ORAL 021445-001 Oct 25, 2002 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ZETIA

Country Patent Number Estimated Expiration
Japan 2007211031 ⤷  Free Forever Trial
Japan H08509989 ⤷  Free Forever Trial
World Intellectual Property Organization (WIPO) 02058732 ⤷  Free Forever Trial
Austria 369851 ⤷  Free Forever Trial
Australia 7795294 ⤷  Free Forever Trial
Poland 364178 ⤷  Free Forever Trial
World Intellectual Property Organization (WIPO) 02058731 ⤷  Free Forever Trial
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for ZETIA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0720599 SPC/GB03/023 United Kingdom ⤷  Free Forever Trial PRODUCT NAME: EZETIMIBE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: DE 54486.00.00 20021017; DE 54488.00.00 20021017; DE 54487.00.00 20021017; DE 54489.00.00 20021017; UK PL 19945/0001 20030404; UK PL 19945/0002 20030404
0720599 CR 2014 00048 Denmark ⤷  Free Forever Trial PRODUCT 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 SPC/GB05/010 United Kingdom ⤷  Free Forever 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
0720599 26/2005 Austria ⤷  Free Forever Trial PRODUCT NAME: EZETIMIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON KOMBINIERT MIT SIMVASTATIN; NAT. REGISTRATION NO/DATE: 1-25673 - 1-25676 20041228; FIRST REGISTRATION: DE 58874.00.00 - 58874.03.00; 58878.00.00 - 20040402
0720599 92545 Luxembourg ⤷  Free Forever Trial PRODUCT NAME: EZETIMIBE EN COMBINAISON AVEC ATORVASTATINE OU LEURS SELS PHARMACEUTIQUEMENT ACCEPTEES, Y COMPRIS ATORVASTATINE SOUS FORME D'ATORVASTATINE CALCIQUE TRIHYDRATEE; FIRST REGISTRATION: 20140910
0720599 10399001 Germany ⤷  Free Forever Trial PRODUCT NAME: EZETIMIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ HIERVON; REGISTRATION NO/DATE: 54486.00.00 20021017
0720599 2003/014 Ireland ⤷  Free Forever 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Dow
Mallinckrodt
Moodys
Colorcon
McKesson
AstraZeneca

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