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Last Updated: April 25, 2024

ZETIA Drug Patent Profile


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

Zetia is a drug marketed by Organon and is included in one NDA. There is one patent 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-six 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.

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Paragraph IV (Patent) Challenges for ZETIA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ZETIA Tablets ezetimibe 10 mg 021445 1 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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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 ZETIA

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

International Patents for ZETIA

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

Country Patent Number Title Estimated Expiration
Russian Federation 2003126185 ⤷  Try a Trial
Israel 156445 COMPOSITION OF STEROL ABSORPTION INHIBITOR OR THERAPEUTIC COMBINATION THEREOF WITH CHOLESTEROL BIOSYNTHESIS INHIBITOR, WHICH MAY FURTHER COMPRISE PEROXISOME PROLIFERATOR ACTIVATED RECEPTOR (PPAR) ACTIVATOR ⤷  Try a Trial
Slovenia 1347987 ⤷  Try a Trial
Finland 110321 ⤷  Try a Trial
Japan 2012087149 COMBINATIONS OF PEROXISOME PROLIFERATOR-ACTIVATED RECEPTOR (PPAR) ACTIVATORS AND STEROL ABSORPTION INHIBITORS AND TREATMENTS FOR VASCULAR INDICATIONS ⤷  Try a Trial
Japan 4777602 ⤷  Try a Trial
Denmark 0720599 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ZETIA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0720599 03C0028 France ⤷  Try a Trial PRODUCT NAME: EZETIMIBE; NAT. REGISTRATION NO/DATE: NL28237 20030611; FIRST REGISTRATION: DE - 54486.00.00 A 54489.00.00 20021017
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 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 SZ 20/2003 Austria ⤷  Try a Trial PRODUCT NAME: EZETIMIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON
0720599 SPC/GB03/023 United Kingdom ⤷  Try a 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 20/2003 Austria ⤷  Try a Trial PRODUCT NAME: EZETIMIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; NAT. REGISTRATION NO/DATE: 1-24902 1-24904 20030415; FIRST REGISTRATION: DE 54486.00.00 - 54489.00.00 20021017
0720599 300172 Netherlands ⤷  Try a Trial 300172, 20140914, EXPIRES: 20190401
>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.