VYTORIN Drug Patent Profile

When do Vytorin patents expire, and what generic alternatives are available?

Vytorin is a drug marketed by Organon and is included in one NDA.

The generic ingredient in VYTORIN 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 Vytorin

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

Summary for VYTORIN

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	41
Patent Applications:	206
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for VYTORIN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VYTORIN
What excipients (inactive ingredients) are in VYTORIN?	VYTORIN excipients list
DailyMed Link:	VYTORIN at DailyMed

See drug prices for VYTORIN

See drug sales revenues for VYTORIN

Recent Clinical Trials for VYTORIN

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

Sponsor	Phase
Samsung Medical Center	Phase 4
Cairo University	N/A
Aswan Heart Centre	N/A

See all VYTORIN clinical trials

Pharmacology for VYTORIN

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

Paragraph IV (Patent) Challenges for VYTORIN

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 VYTORIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon	VYTORIN	ezetimibe; simvastatin	TABLET;ORAL	021687-001	Jul 23, 2004	AB	RX	Yes	No
Organon	VYTORIN	ezetimibe; simvastatin	TABLET;ORAL	021687-004	Jul 23, 2004	AB	RX	Yes	Yes
Organon	VYTORIN	ezetimibe; simvastatin	TABLET;ORAL	021687-002	Jul 23, 2004	AB	RX	Yes	No
Organon	VYTORIN	ezetimibe; simvastatin	TABLET;ORAL	021687-003	Jul 23, 2004	AB	RX	Yes	No

Expired US Patents for VYTORIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	VYTORIN	ezetimibe; simvastatin	TABLET;ORAL	021687-003	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	021687-002	Jul 23, 2004
Organon	VYTORIN	ezetimibe; simvastatin	TABLET;ORAL	021687-004	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

International Patents for VYTORIN

See the table below for patents covering VYTORIN around the world.

Country	Patent Number	Title	Estimated Expiration
Malaysia	148689	PHARMACEUTICAL FORMULATION
Canada	1199322	COMPOSES ANTIHYPERCHOLESTEROLEMIQUES (ANTIHYPERCHOLESTEROLEMIC COMPOUNDS)
Hong Kong	16488	6(R)-(2-(8'-ACYLOXY-2'-METHYL-6-METHYL(OR HYDROGEN)-POLYHYDRONAPHTHYL-1')-ETHYL)-4-(R)-HYDROXY-3,4,5,6-TETRAHYDRO-2H-PYRAN-2-ONES,THE HYDROXY ACID FORM OF SAID PYRANONES,THE PHARMACEUTICALLY ACCEPTABLE SALTS OF SAID HYDROXY ACIDS,AND THE LOWER ALKYL,AND PHENYL,DIMETHYLAMINO OR ACETYLAMINO SUBSTITUTED LOWER ALKYL ESTERS OF SAID HYDROXY ACID,PROCESSES FOR PREPARING THE SAME,AND A PHARMACEUTICAL ANTIHYPERCHOLESTEROLEMIC COMPOSITION CONTAINING THE SAME
Australia	681445
Montenegro	P30808	SASTAV KOJI NE POSJEDUJE ASKORBINSKU KISJELINU I KOJI SADRŽI INHIBITOR APSORPCIJE HOLESTEROLA, INHIBITOR HMG-COA REDUKTAZE I STABILIZUJUĆI AGENS (COMPOSITION COMPRISING A CHOLESTEROL ABSORPTION INHIBITOR, AN HMGCOA REDUCTASE INHIBITOR AND A STABILIZING AGENT)
Japan	2005538104
Zimbabwe	2681	NEW ANTIHYPERCHOLESTEROLEMIC COMPOUNDS INTERMEDIATES AND PROCESSES

Supplementary Protection Certificates for VYTORIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0720599	SPC/GB03/023	United Kingdom		PRODUCT NAME: EZETIMIBE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: DE 54486.00.00 20021017; DE 54488.00.00 20021017; DE 54487.00.00 20021017; DE 54489.00.00 20021017; UK PL 19945/0001 20030404; UK PL 19945/0002 20030404
0720599	122014000088	Germany		PRODUCT NAME: EZETIMIB ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON IN KOMBINATION MIT ATORVASTATIN ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON, INSBESONDERE ATORVASTATIN ALS ATORVASTATINCALCIUMTRIHYDRAT; NAT. REGISTRATION NO/DATE: 90223.00.00 20141113; FIRST REGISTRATION: FRANKREICH CIS: 6 928 917 6 20140912
0720599	300172	Netherlands		300172, 20140914, EXPIRES: 20190401
0720599	CA 2005 00003	Denmark
0720599	SZ 26/2005	Austria
0720599	20/2003	Austria		PRODUCT NAME: EZETIMIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; NAT. REGISTRATION NO/DATE: 1-24902 1-24904 20030415; FIRST REGISTRATION: DE 54486.00.00 - 54489.00.00 20021017
0720599	C300132	Netherlands		PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; NATL REGISTRATION: RVG 28626 20030418; FIRST REGISTRATION: DE 54486.00.00, 54487.00.00, 54488.00.00, 54489.00.00 20021017