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Last Updated: May 27, 2022

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 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.

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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

ZETIA is protected by one US patents.

Patents protecting ZETIA

Sterol absorption inhibitor compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Organon ZETIA ezetimibe TABLET;ORAL 021445-001 Oct 25, 2002 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Organon ZETIA ezetimibe TABLET;ORAL 021445-001 Oct 25, 2002 See Plans and Pricing See Plans and Pricing
Organon ZETIA ezetimibe TABLET;ORAL 021445-001 Oct 25, 2002 See Plans and Pricing See Plans and Pricing
Organon ZETIA ezetimibe TABLET;ORAL 021445-001 Oct 25, 2002 See Plans and Pricing See Plans and Pricing
>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
Finland 961300 See Plans and Pricing
Portugal 1385548 See Plans and Pricing
Canada 2460344 See Plans and Pricing
Mexico PA04002572 METODOS PARA EL TRATAMIENTO O PREVENCION DE INFLAMACION VASCULAR USANDO INHIBIDORES DE ABSORCION DE ESTEROL. (METHODS FOR TREATING OR PREVENTING VASCULAR INFLAMMATION USING STEROL ABSORPTION INHIBITOR(S).) See Plans and Pricing
Taiwan 200744638 See Plans and Pricing
South Korea 186853 See Plans and Pricing
Slovakia 9482003 Combinations of peroxisome proliferator-activated receptor (PPAR) activator(s) and sterol absorption inhibitor(s) and treatments for vascular indications See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ZETIA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0720599 122014000088 Germany See Plans and Pricing PRODUCT NAME: EZETIMIB ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON IN KOMBINATION MIT ATORVASTATIN ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON, INSBESONDERE ATORVASTATIN ALS ATORVASTATINCALCIUMTRIHYDRAT; NAT. REGISTRATION NO/DATE: 90223.00.00 20141113; FIRST REGISTRATION: FRANKREICH CIS: 6 928 917 6 20140912
0720599 10399001 Germany See Plans and Pricing PRODUCT NAME: EZETIMIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ HIERVON; REGISTRATION NO/DATE: 54486.00.00 20021017
0720599 CR 2014 00048 Denmark See Plans and Pricing 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 26/2005 Austria See Plans and Pricing 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 See Plans and Pricing 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 SZ 26/2005 Austria See Plans and Pricing
0720599 CR 2014 00050 Denmark See Plans and Pricing 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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Serving leading biopharmaceutical companies globally:

Express Scripts
Moodys
McKesson
Mallinckrodt
Boehringer Ingelheim
Colorcon

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