ATORVASTATIN CALCIUM; EZETIMIBE - Generic Drug Details

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What are the generic sources for atorvastatin calcium; ezetimibe and what is the scope of freedom to operate?

Atorvastatin calcium; ezetimibe is the generic ingredient in two branded drugs marketed by Organon and Althera Pharms, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for ATORVASTATIN CALCIUM; EZETIMIBE

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Clinical Trials:	3
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ATORVASTATIN CALCIUM; EZETIMIBE
DailyMed Link:	ATORVASTATIN CALCIUM; EZETIMIBE at DailyMed

Recent Clinical Trials for ATORVASTATIN CALCIUM; EZETIMIBE

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

Sponsor	Phase
Chong Kun Dang Pharmaceutical	Phase 1
Merck Sharp & Dohme Corp.	Phase 3

See all ATORVASTATIN CALCIUM; EZETIMIBE clinical trials

Pharmacology for ATORVASTATIN CALCIUM; EZETIMIBE

Drug Class	Dietary Cholesterol Absorption Inhibitor HMG-CoA Reductase Inhibitor
Mechanism of Action	Hydroxymethylglutaryl-CoA Reductase Inhibitors
Physiological Effect	Decreased Cholesterol Absorption

Anatomical Therapeutic Chemical (ATC) Classes for ATORVASTATIN CALCIUM; EZETIMIBE

C10AA	HMG CoA reductase inhibitors
C10A	LIPID MODIFYING AGENTS, PLAIN
C10	LIPID MODIFYING AGENTS
C	Cardiovascular system

C10AX	Other lipid modifying agents
C10A	LIPID MODIFYING AGENTS, PLAIN
C10	LIPID MODIFYING AGENTS
C	Cardiovascular system

US Patents and Regulatory Information for ATORVASTATIN CALCIUM; 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
Althera Pharms	LYPQOZET	atorvastatin calcium; ezetimibe	TABLET;ORAL	206084-004	Apr 26, 2017		RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Organon	LIPTRUZET	atorvastatin calcium; ezetimibe	TABLET;ORAL	200153-002	May 3, 2013		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Althera Pharms	LYPQOZET	atorvastatin calcium; ezetimibe	TABLET;ORAL	206084-002	Apr 26, 2017		RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Althera Pharms	LYPQOZET	atorvastatin calcium; ezetimibe	TABLET;ORAL	206084-003	Apr 26, 2017		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 ATORVASTATIN CALCIUM; EZETIMIBE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	LIPTRUZET	atorvastatin calcium; ezetimibe	TABLET;ORAL	200153-001	May 3, 2013	⤷ Sign Up	⤷ Sign Up
Organon	LIPTRUZET	atorvastatin calcium; ezetimibe	TABLET;ORAL	200153-003	May 3, 2013	⤷ Sign Up	⤷ Sign Up
Organon	LIPTRUZET	atorvastatin calcium; ezetimibe	TABLET;ORAL	200153-001	May 3, 2013	⤷ Sign Up	⤷ Sign Up
Organon	LIPTRUZET	atorvastatin calcium; ezetimibe	TABLET;ORAL	200153-004	May 3, 2013	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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