ZETIA Drug Patent Profile

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-seven 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 26^th, 2015.

Summary for ZETIA

International Patents:	235
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	113
Patent Applications:	4,136
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ZETIA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZETIA
What excipients (inactive ingredients) are in ZETIA?	ZETIA excipients list
DailyMed Link:	ZETIA at DailyMed

See drug prices for ZETIA

See drug sales revenues for ZETIA

Pharmacology for ZETIA

Drug Class	Dietary Cholesterol Absorption Inhibitor
Physiological Effect	Decreased Cholesterol Absorption

Anatomical Therapeutic Chemical (ATC) Classes for ZETIA

C10AX	Other lipid modifying agents
C10A	LIPID MODIFYING AGENTS, PLAIN
C10	LIPID MODIFYING AGENTS
C	Cardiovascular system

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					Y

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
Organon	ZETIA	ezetimibe	TABLET;ORAL	021445-001	Oct 25, 2002
Organon	ZETIA	ezetimibe	TABLET;ORAL	021445-001	Oct 25, 2002
Organon	ZETIA	ezetimibe	TABLET;ORAL	021445-001	Oct 25, 2002

International Patents for ZETIA

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

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2356550	КОМБИНАЦИИ АКТИВАТОРА (АКТИВАТОРОВ) РЕЦЕПТОРА, АКТИВИРУЕМОГО ПРОЛИФЕРАТОРОМ ПЕРОКСИСОМ (РАПП), И ИНГИБИТОРА (ИНГИБИТОРОВ) ВСАСЫВАНИЯ СТЕРИНА И ЛЕЧЕНИЕ ЗАБОЛЕВАНИЙ СОСУДОВ (COMBINED ACTIVATOR (ACTIVATORS) OF RECEPTOR ACTIVATED WITH PEROXISE PROLIFERATOR (RAPP), AND STEROL ABSORPTION INHIBITOR (INHIBITORS) AND TREATMENT OF VESSEL DISEASES)
Czech Republic	301871	Kombinace aktivátoru receptoru, aktivovaného proliferátorem peroxisomu fenofibrátu s inhibitorem vstrebávání sterolu ezetimibem pro použití pri cévních chorobách (Combinations of peroxisome proliferator-activated receptor activator phenofibrate with sterol absorption inhibitor ezetimibe for use in the treatment of vascular diseases)
Canada	2434504
China	1131416

Supplementary Protection Certificates for ZETIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0720599	SPC/GB05/010	United Kingdom		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	300688	Netherlands		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	300132	Netherlands		300132, 20140914, EXPIRES: 20171016
0720599	92544	Luxembourg		PRODUCT NAME: EZETIMIBE EN COMBINAISON AVEC ROSUVASTATINE OU LEURS SELS PHARMACEUTIQUEMENT ACCEPTEES, Y COMPRIS ROSUVASTATINE SOUD FORME DE SEL DE ZINC; FIRST REGISTRATION DATE: 20140724