EZETIMIBE AND SIMVASTATIN Drug Patent Profile

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Ezetimibe And Simvastatin is a drug marketed by Alkem Labs Ltd, Amneal Pharms Co, Ani Pharms, Aurobindo Pharma Usa, Dr Reddys Labs Sa, Glenmark Pharms Ltd, and Watson Labs Inc. and is included in seven NDAs.

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

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

US Patents:	0
Applicants:	7
NDAs:	7
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	107
Patent Applications:	234
Formulation / Manufacturing:	see details
DailyMed Link:	EZETIMIBE AND SIMVASTATIN at DailyMed

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

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

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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	202968-004	Apr 26, 2017	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Alkem Labs Ltd	EZETIMIBE AND SIMVASTATIN	ezetimibe; simvastatin	TABLET;ORAL	209222-001	Dec 22, 2017	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Dr Reddys Labs Sa	EZETIMIBE AND SIMVASTATIN	ezetimibe; simvastatin	TABLET;ORAL	200909-002	Apr 26, 2017	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Glenmark Pharms Ltd	EZETIMIBE AND SIMVASTATIN	ezetimibe; simvastatin	TABLET;ORAL	208699-004	Jun 27, 2019	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Amneal Pharms Co	EZETIMIBE AND SIMVASTATIN	ezetimibe; simvastatin	TABLET;ORAL	208831-003	Nov 21, 2017	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Alkem Labs Ltd	EZETIMIBE AND SIMVASTATIN	ezetimibe; simvastatin	TABLET;ORAL	209222-004	Dec 22, 2017	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Ani Pharms	EZETIMIBE AND SIMVASTATIN	ezetimibe; simvastatin	TABLET;ORAL	201890-004	Apr 26, 2017		DISCN	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