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-eight 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:	28
Raw Ingredient (Bulk) Api Vendors:	113
Clinical Trials:	349
Patent Applications:	6,424
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
Orient Pharma	EZETIMIBE	ezetimibe	TABLET;ORAL	215693-001	Sep 13, 2022	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Dr Reddys Labs Sa	EZETIMIBE AND SIMVASTATIN	ezetimibe; simvastatin	TABLET;ORAL	200909-002	Apr 26, 2017	AB	RX	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
Organon	VYTORIN	ezetimibe; simvastatin	TABLET;ORAL	021687-001	Jul 23, 2004	AB	RX	Yes	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
>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	230253	Peroxiszóma proliferátor-aktivált receptor (PPAR) aktivátor(ok) és szterin-abszorpció inhibitor(ok) kombinációi és alkalmazásuk vaszkuláris indikációk kezelésére (Combinations of peroxisome proliferator-activated receptor (ppar) activator(s) and sterol absorption inhibitor(s) and their use in the treatment of vascular indications)	⤷ Sign Up
Slovenia	1353694		⤷ Sign Up
Yugoslavia	58603		⤷ Sign Up
South Korea	20030063414		⤷ 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	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	CR 2014 00048	Denmark	⤷ Sign Up	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	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
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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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