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Last Updated: April 16, 2024

EZETIMIBE - Generic Drug Details

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What are the generic drug sources for ezetimibe and what is the scope of patent protection?

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-seven 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:	27
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
Organon and Co	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

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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
Glenmark Pharms Ltd	EZETIMIBE AND SIMVASTATIN	ezetimibe; simvastatin	TABLET;ORAL	208699-001	Jun 27, 2019	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Althera Pharms	ROSZET	ezetimibe; rosuvastatin calcium	TABLET;ORAL	213072-002	Mar 23, 2021		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Teva Pharms Usa	EZETIMIBE	ezetimibe	TABLET;ORAL	078724-001	Jun 12, 2017		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Alkem Labs Ltd	EZETIMIBE AND SIMVASTATIN	ezetimibe; simvastatin	TABLET;ORAL	209222-002	Dec 22, 2017	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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	⤷ Try a Trial	⤷ Try a Trial
Organon	ZETIA	ezetimibe	TABLET;ORAL	021445-001	Oct 25, 2002	⤷ Try a Trial	⤷ Try a Trial
Organon	ZETIA	ezetimibe	TABLET;ORAL	021445-001	Oct 25, 2002	⤷ Try a Trial	⤷ Try a Trial
Organon	ZETIA	ezetimibe	TABLET;ORAL	021445-001	Oct 25, 2002	⤷ Try a Trial	⤷ Try a Trial
>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
Hungary	0303917		⤷ Try a Trial
Cyprus	1107045		⤷ Try a Trial
Cyprus	1110894		⤷ Try a Trial
World Intellectual Property Organization (WIPO)	0250090		⤷ Try a Trial
>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	300689	Netherlands	⤷ Try a Trial	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/GB03/023	United Kingdom	⤷ Try a Trial	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
0720599	05C0040	France	⤷ Try a Trial	PRODUCT NAME: EZETIMIBE; SIMVASTATINE; NAT. REGISTRATION NO/DATE: NL 31849 20050728; FIRST REGISTRATION: DE - 58 878 00 00 20040402
0720599	92544	Luxembourg	⤷ Try a Trial	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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