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:	234
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

Anatomical Therapeutic Chemical (ATC) Classes for VYTORIN

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 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	021687-004	Jul 23, 2004
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	021687-001	Jul 23, 2004
Organon	VYTORIN	ezetimibe; simvastatin	TABLET;ORAL	021687-002	Jul 23, 2004

International Patents for VYTORIN

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

Country	Patent Number	Title	Estimated Expiration
New Zealand	200588	6(R)-(2-(8(S)-(2,2-DIMETHYLBUTYRYLOXY)-2(S),6(S)-DIMETHYL-1,2,3,4,4A(S),5,6,7,8,8A(S)-DECAHYDRONAPHTHYL-1(S))-ETHYL)-4(R)-HYDROXY-3,4,5,6-TETRAHYDRO-2H-PYRAN-2-ONE AND PHARMACEUTICAL COMPOSITIONS
Malaysia	8700745	6(R)-(2-8-ACYLOXY-2'-METHYL-6'METHYL(OR HYDROGEN)-POLYHYDRONAPTHYL-1')-ETHYL)-4(R)-HYDROXY-3,4,5,6-TETRAHYDRO-24-PYRAN-2-ONES, THE HYDROXY ACID FROM OF SAID PYRANONES, THE PARMACEUTICALLY ACCEPTABLE SATLS 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 PARMACEUTICAL ANTIHYPERCHOLESTEROLEMIC COMPOSITION CONTAINING THE SAME.
Slovakia	281067
China	1310643
Croatia	P930775

Supplementary Protection Certificates for VYTORIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0720599	CR 2014 00048	Denmark		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	10399001	Germany		PRODUCT NAME: EZETIMIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ HIERVON; REGISTRATION NO/DATE: 54486.00.00 20021017
0720599	122004000026	Germany		PRODUCT NAME: EZETIMIB ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON IN KOMBINATION MIT SIMVASTATIN; NAT. REGISTRATION NO/DATE: 58866.00.00 58866.01.00 58866.02.00 58866.03.00 58870.00.00 58870.01.00 58870.02.00 58870.03.00 58874.00.00 58874.01.00 58874.02.00 58874.03.00 58878.00.00 58878.01.00 58878.02.00 58878.03.00 20040402 FIRST REGISTRATION: DE 58866.00.00 - 58866.03.00 58870.00.00 - 58870.03.00 58874.00.00 - 58874.03.00 58878.00.00 - 58878.03.00 20040402
0720599	92545	Luxembourg		PRODUCT NAME: EZETIMIBE EN COMBINAISON AVEC ATORVASTATINE OU LEURS SELS PHARMACEUTIQUEMENT ACCEPTEES, Y COMPRIS ATORVASTATINE SOUS FORME D'ATORVASTATINE CALCIQUE TRIHYDRATEE; FIRST REGISTRATION: 20140910
0720599	CR 2014 00050	Denmark		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