Ezetimibe; simvastatin - Generic Drug Details

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

Ezetimibe; simvastatin is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Amneal Pharms Co, Ani Pharms, Aurobindo Pharma Usa, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Watson Labs Inc, and Organon, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

Thirteen suppliers are listed for this compound.

Summary for ezetimibe; simvastatin

US Patents:	0
Tradenames:	2
Applicants:	8
NDAs:	8
Finished Product Suppliers / Packagers:	13
Clinical Trials:	107
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ezetimibe; simvastatin
DailyMed Link:	ezetimibe; simvastatin at DailyMed

Recent Clinical Trials for ezetimibe; simvastatin

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

Sponsor	Phase
The University of Hong Kong	Phase 4
Aswan Heart Centre	N/A
Cairo University	N/A

See all ezetimibe; simvastatin clinical trials

Pharmacology for ezetimibe; simvastatin

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 ezetimibe; simvastatin

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

Paragraph IV (Patent) Challenges for EZETIMIBE; SIMVASTATIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VYTORIN	Tablets	ezetimibe; simvastatin	10 mg/10 mg 10 mg/20 mg 10 mg/40 mg 10 mg/80 mg	021687	1	2009-07-27

US Patents and Regulatory Information for ezetimibe; simvastatin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ani Pharms	EZETIMIBE AND SIMVASTATIN	ezetimibe; simvastatin	TABLET;ORAL	201890-002	Apr 26, 2017		DISCN	No	No
Ani Pharms	EZETIMIBE AND SIMVASTATIN	ezetimibe; simvastatin	TABLET;ORAL	201890-001	Apr 26, 2017		DISCN	No	No
Amneal Pharms Co	EZETIMIBE AND SIMVASTATIN	ezetimibe; simvastatin	TABLET;ORAL	208831-002	Nov 21, 2017	AB	RX	No	No
Amneal Pharms Co	EZETIMIBE AND SIMVASTATIN	ezetimibe; simvastatin	TABLET;ORAL	208831-004	Nov 21, 2017	AB	RX	No	No
Alkem Labs Ltd	EZETIMIBE AND SIMVASTATIN	ezetimibe; simvastatin	TABLET;ORAL	209222-002	Dec 22, 2017	AB	RX	No	No
Dr Reddys Labs Sa	EZETIMIBE AND SIMVASTATIN	ezetimibe; simvastatin	TABLET;ORAL	200909-003	Apr 26, 2017	AB	RX	No	No
Glenmark Pharms Ltd	EZETIMIBE AND SIMVASTATIN	ezetimibe; simvastatin	TABLET;ORAL	208699-002	Jun 27, 2019	AB	RX	No	No

Expired US Patents for ezetimibe; simvastatin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	VYTORIN	ezetimibe; simvastatin	TABLET;ORAL	021687-004	Jul 23, 2004
Organon	VYTORIN	ezetimibe; simvastatin	TABLET;ORAL	021687-003	Jul 23, 2004
Organon	VYTORIN	ezetimibe; simvastatin	TABLET;ORAL	021687-003	Jul 23, 2004
Organon	VYTORIN	ezetimibe; simvastatin	TABLET;ORAL	021687-001	Jul 23, 2004
Organon	VYTORIN	ezetimibe; simvastatin	TABLET;ORAL	021687-004	Jul 23, 2004
Organon	VYTORIN	ezetimibe; simvastatin	TABLET;ORAL	021687-001	Jul 23, 2004
Organon	VYTORIN	ezetimibe; simvastatin	TABLET;ORAL	021687-001	Jul 23, 2004