Ezetimibe - Generic Drug Details

What are the generic drug sources for ezetimibe and what is the scope of freedom to operate?

Ezetimibe is the generic ingredient in five branded drugs marketed by Accord Hlthcare, Alkem Labs Ltd, Amneal Pharms Co, Apotex, Aurobindo Pharma, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Ohm Labs Inc, Orient Pharma, Rising, Sandoz, Sciegen Pharms Inc, Teva Pharms Usa, Watson Labs Inc, Zydus Pharms, Organon, Althera Pharms, Ani Pharms, Aurobindo Pharma Usa, and Dr Reddys Labs Sa, and is included in twenty-five NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

There are twenty-four drug master file entries for ezetimibe. Twenty-six suppliers are listed for this compound.

Summary for ezetimibe

International Patents:	235
US Patents:	3
Tradenames:	5
Applicants:	20
NDAs:	25
Drug Master File Entries:	24
Finished Product Suppliers / Packagers:	26
Raw Ingredient (Bulk) Api Vendors:	113
Clinical Trials:	343
Patent Applications:	6,424
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for ezetimibe
Drug Sales Revenues:	Drug sales revenues for ezetimibe
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ezetimibe
What excipients (inactive ingredients) are in ezetimibe?	ezetimibe excipients list
DailyMed Link:	ezetimibe at DailyMed

See drug prices for ezetimibe

See drug sales revenues for ezetimibe

Recent Clinical Trials for ezetimibe

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
dotter	Phase 4
Novartis Pharmaceuticals	Phase 3
Iqvia Pty Ltd	Phase 4

See all ezetimibe clinical trials

Pharmacology for ezetimibe

Drug Class	Dietary Cholesterol Absorption Inhibitor
Physiological Effect	Decreased Cholesterol Absorption

Medical Subject Heading (MeSH) Categories for ezetimibe

Anticholesteremic Agents

Anatomical Therapeutic Chemical (ATC) Classes for ezetimibe

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

Paragraph IV (Patent) Challenges for EZETIMIBE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZETIA	Tablets	ezetimibe	10 mg	021445	1	2006-10-25

US Patents and Regulatory Information for ezetimibe

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal Pharms Co	EZETIMIBE AND SIMVASTATIN	ezetimibe; simvastatin	TABLET;ORAL	208831-002	Nov 21, 2017	AB	RX	No	No
Organon	VYTORIN	ezetimibe; simvastatin	TABLET;ORAL	021687-003	Jul 23, 2004	AB	RX	Yes	No
Althera Pharms	ROSZET	ezetimibe; rosuvastatin calcium	TABLET;ORAL	213072-002	Mar 23, 2021		DISCN	Yes	No			Y
Dr Reddys Labs Sa	EZETIMIBE AND SIMVASTATIN	ezetimibe; simvastatin	TABLET;ORAL	200909-001	Apr 26, 2017	AB	RX	No	No
Glenmark Pharms Ltd	EZETIMIBE	ezetimibe	TABLET;ORAL	078560-001	Jun 26, 2015	AB	RX	No	No
Organon	ZETIA	ezetimibe	TABLET;ORAL	021445-001	Oct 25, 2002	AB	RX	Yes	Yes					Y

Expired US Patents for ezetimibe

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 ezetimibe

Country	Patent Number	Title	Estimated Expiration
Serbia	51449	KOMBINACIJA AKTIVATORA PEROKSIZOM PROLIFERATOR-AKTIVIRANOG RECEPTORA (PPAR) I INHIBITORA APSORPCIJE STEROLA I LEČENJE VASKULARNIH INDIKACIJA (COMBINATIONS OF PEROXISOME PROLIFERATOR-ACTIVATED RECEPTOR (PPAR) ACTIVATOR(S) AND STEROL ABSORPTION INHIBITOR(S) AND TREATMENTS FOR VASCULAR INDICATIONS)
Denmark	1347987
Brazil	0206644
Cyprus	1107174
Norway	20033355
Japan	4351842

Supplementary Protection Certificates for ezetimibe

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0720599	C300172	Netherlands		PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN SIMVASTATINE; NAT. REGISTRATION NO/DATE: RVG 30927RVG 30928RVG 30929RVG 30930 2004221122; FIRST REGISTRATION: 58874.00.0058874.01.0058874.02.0058874.03.0058878.00.0058878.01.0058878.02.0058878.03.0058866.00.0058866.01.0058866.02.0058866.03.0058870.00.0058870.01.0058870.02.0058870.03.00 2004020402
0720599	CR 2014 00048	Denmark		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	C300132	Netherlands		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		PRODUCT NAME: EZETIMIBE; SIMVASTATINE; NAT. REGISTRATION NO/DATE: NL 31849 20050728; FIRST REGISTRATION: DE - 58 878 00 00 20040402
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	SPC/GB03/023	United Kingdom		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