ZETIA Drug Patent Profile

Which patents cover Zetia, and when can generic versions of Zetia launch?

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 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
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
Poland	368653
Brazil	0206639
Israel	156488
European Patent Office	1413331	Combinaisons de l'activateur du récepteur du peroxisome (PPAR) fenofibrate avec l'inhibiteur d'absorption de stérol ezetimibe pour des indications vasculaires (Combinations of the peroxisome proliferator-activated receptor (PPAR) activator fenofibrate with sterol absorption inhibitor ezetimibe for vascular indications)
Japan	2004521893
Hungary	0401501
Australia	2002237927

Supplementary Protection Certificates for ZETIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0720599	122004000026	Germany		PRODUCT NAME: EZETIMIB ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON IN KOMBINATION MIT SIMVASTATIN; NAT. REGISTRATION NO/DATE: 58866.00.00 58866.01.00 58866.02.00 58866.03.00 58870.00.00 58870.01.00 58870.02.00 58870.03.00 58874.00.00 58874.01.00 58874.02.00 58874.03.00 58878.00.00 58878.01.00 58878.02.00 58878.03.00 20040402 FIRST REGISTRATION: DE 58866.00.00 - 58866.03.00 58870.00.00 - 58870.03.00 58874.00.00 - 58874.03.00 58878.00.00 - 58878.03.00 20040402
0720599	300689	Netherlands		PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ATORVASTATINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER ATORVASTATINE CALCIUM TRIHYDRATE; NATIONAL REGISTRATION NO/DATE: RVG114373-114376 20141027; FIRST REGISTRATION: FR 2014091200122 20140912
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	05C0040	France		PRODUCT NAME: EZETIMIBE; SIMVASTATINE; NAT. REGISTRATION NO/DATE: NL 31849 20050728; FIRST REGISTRATION: DE - 58 878 00 00 20040402
0720599	20/2003	Austria		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	SZ 20/2003	Austria		PRODUCT NAME: EZETIMIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON
0720599	26/2005	Austria		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