Ezetimibe - Generic Drug Details

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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, Macleods Pharms Ltd, 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-six 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-seven suppliers are listed for this compound.

Summary for ezetimibe

International Patents:	235
US Patents:	3
Tradenames:	5
Applicants:	21
NDAs:	26
Drug Master File Entries:	24
Finished Product Suppliers / Packagers:	27
Raw Ingredient (Bulk) Api Vendors:	113
Clinical Trials:	347
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
Bispebjerg Hospital	N/A
Regionshospitalet Silkeborg	N/A
Nykøbing Falster County Hospital	N/A

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma	EZETIMIBE	ezetimibe	TABLET;ORAL	209838-001	Aug 25, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Althera Pharms	ROSZET	ezetimibe; rosuvastatin calcium	TABLET;ORAL	213072-004	Mar 23, 2021		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Aurobindo Pharma Usa	EZETIMIBE AND SIMVASTATIN	ezetimibe; simvastatin	TABLET;ORAL	200082-001	Dec 17, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rising	EZETIMIBE	ezetimibe	TABLET;ORAL	201790-001	Apr 26, 2019		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Macleods Pharms Ltd	EZETIMIBE	ezetimibe	TABLET;ORAL	211159-001	Apr 29, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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 ezetimibe

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	ZETIA	ezetimibe	TABLET;ORAL	021445-001	Oct 25, 2002	⤷ Sign Up	⤷ Sign Up
Organon	ZETIA	ezetimibe	TABLET;ORAL	021445-001	Oct 25, 2002	⤷ Sign Up	⤷ Sign Up
Organon	ZETIA	ezetimibe	TABLET;ORAL	021445-001	Oct 25, 2002	⤷ Sign Up	⤷ Sign Up
Organon	ZETIA	ezetimibe	TABLET;ORAL	021445-001	Oct 25, 2002	⤷ Sign Up	⤷ Sign Up
Organon	ZETIA	ezetimibe	TABLET;ORAL	021445-001	Oct 25, 2002	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for ezetimibe

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Country	Patent Number	Title	Estimated Expiration
New Zealand	525722	Sugar-substituted 2-azetidinones useful as hypocholesterolemic agents	⤷ Sign Up
Japan	2004521893		⤷ Sign Up
Argentina	035611	2 -AZETIDINONAS SUSTITUIDAS CON AZUCARES, COMPOSICION FARMACEUTICA, UN KIT, USO DE DICHOS COMPUESTOS PARA LA FABRICACION DE MEDICAMENTOS UTILES COMO AGENTES HIPOCOLESTEROLEMICOS.	⤷ Sign Up
Portugal	1593670		⤷ Sign Up
Slovenia	1363668		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ezetimibe

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0720599	C300688	Netherlands	⤷ Sign Up	PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ROSUVASTATINE; NAT. REGISTRATION NO/DATE: RVG114002-004RVG 114008-010 2014110811; FIRST REGISTRATION: 13-9663 - 9665 20140724
0720599	03C0028	France	⤷ Sign Up	PRODUCT NAME: EZETIMIBE; NAT. REGISTRATION NO/DATE: NL28237 20030611; FIRST REGISTRATION: DE - 54486.00.00 A 54489.00.00 20021017
0720599	CR 2014 00050	Denmark	⤷ Sign Up	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
0720599	92544	Luxembourg	⤷ Sign Up	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
0720599	C300172	Netherlands	⤷ Sign Up	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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