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Last Updated: November 21, 2024

EZETIMIBE Drug Patent Profile

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When do Ezetimibe patents expire, and when can generic versions of Ezetimibe launch?

Ezetimibe is a drug 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, Ani Pharms, Aurobindo Pharma Usa, and Dr Reddys Labs Sa. and is included in twenty-three NDAs.

The generic ingredient in EZETIMIBE is ezetimibe; simvastatin. There are twenty-four drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the ezetimibe; simvastatin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ezetimibe

A generic version of EZETIMIBE was approved as ezetimibe; simvastatin by DR REDDYS LABS SA on April 26^th, 2017.

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Summary for EZETIMIBE

US Patents:	0
Applicants:	19
NDAs:	23
Finished Product Suppliers / Packagers:	27
Raw Ingredient (Bulk) Api Vendors:	113
Clinical Trials:	349
Patent Applications:	4,136
Drug Prices:	Drug price information for EZETIMIBE
Drug Sales Revenues:	Drug sales revenues for EZETIMIBE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EZETIMIBE
DailyMed Link:	EZETIMIBE at DailyMed

Drug patent expirations by year for EZETIMIBE

Drug Prices for EZETIMIBE

Recent Clinical Trials for EZETIMIBE

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

Sponsor	Phase
Hillerod Hospital, Denmark	N/A
Rigshospitalet, Denmark	N/A
Regionshospitalet Horsens	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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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	202968-001	Apr 26, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma Usa	EZETIMIBE AND SIMVASTATIN	ezetimibe; simvastatin	TABLET;ORAL	200082-004	Dec 17, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ani Pharms	EZETIMIBE AND SIMVASTATIN	ezetimibe; simvastatin	TABLET;ORAL	201890-004	Apr 26, 2017		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Dr Reddys Labs Sa	EZETIMIBE AND SIMVASTATIN	ezetimibe; simvastatin	TABLET;ORAL	200909-001	Apr 26, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ 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
Accord Hlthcare	EZETIMIBE	ezetimibe	TABLET;ORAL	211550-001	Oct 26, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alkem Labs Ltd	EZETIMIBE AND SIMVASTATIN	ezetimibe; simvastatin	TABLET;ORAL	209222-002	Dec 22, 2017	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

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