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

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
Watson Labs Inc	EZETIMIBE AND SIMVASTATIN	ezetimibe; simvastatin	TABLET;ORAL	202968-003	Apr 26, 2017	AB	RX	No	No
Amneal Pharms Co	EZETIMIBE AND SIMVASTATIN	ezetimibe; simvastatin	TABLET;ORAL	208831-003	Nov 21, 2017	AB	RX	No	No
Alkem Labs Ltd	EZETIMIBE AND SIMVASTATIN	ezetimibe; simvastatin	TABLET;ORAL	209222-002	Dec 22, 2017	AB	RX	No	No

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

International Patents for ezetimibe

Country	Patent Number	Title	Estimated Expiration
Portugal	1593670
World Intellectual Property Organization (WIPO)	02058685
China	1483039

Supplementary Protection Certificates for ezetimibe

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	2003/014	Ireland		PRODUCT NAME: EZETIMIBE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NAT REGISTRATION NO/DATE: 1091/1/1 00040127; FIRST REGISTRATION NO/DATE: EU: DE 54489.00.00 54486.00.00 54488.00.00 54487.00.00 20021017; PAEDIATRIC INVESTIGATION PLAN: P/0061/2012