Simvastatin - Generic Drug Details

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

Simvastatin is the generic ingredient in four branded drugs marketed by Tcg Fluent Pharma, Synthon Pharms, Accord Hlthcare, Aurobindo Pharma, Biocon Pharma, Chartwell Rx, Dr Reddys Labs Inc, Hetero Labs Ltd Iii, Invagen Pharms, Ivax Sub Teva Pharms, Lupin, Micro Labs, Mylan Pharms Inc, Oxford Pharms, Sun Pharm Inds Ltd, Watson Labs Teva, Zydus Pharms Usa, Organon, and Merck Sharp Dohme, and is included in nineteen NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Simvastatin has twelve patent family members in twelve countries.

There are forty drug master file entries for simvastatin. Thirty-six suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for simvastatin

International Patents:	12
US Patents:	3
Tradenames:	4
Applicants:	19
NDAs:	19
Drug Master File Entries:	40
Finished Product Suppliers / Packagers:	36
Raw Ingredient (Bulk) Api Vendors:	113
Clinical Trials:	581
Patent Applications:	8,116
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for simvastatin
Drug Sales Revenues:	Drug sales revenues for simvastatin
What excipients (inactive ingredients) are in simvastatin?	simvastatin excipients list
DailyMed Link:	simvastatin at DailyMed

See drug prices for simvastatin

See drug sales revenues for simvastatin

Recent Clinical Trials for simvastatin

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

Sponsor	Phase
State University of New York - Downstate Medical Center	Phase 1/Phase 2
United States Department of Defense	Early Phase 1
National Cancer Institute, Naples	Phase 2

See all simvastatin clinical trials

Generic filers with tentative approvals for SIMVASTATIN

Applicant	Application No.	Strength	Dosage Form
		80MG	TABLET; ORAL
		40MG	TABLET; ORAL
		20MG	TABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for simvastatin

Drug Class	HMG-CoA Reductase Inhibitor
Mechanism of Action	Hydroxymethylglutaryl-CoA Reductase Inhibitors

Medical Subject Heading (MeSH) Categories for simvastatin

Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Hypolipidemic Agents

Anatomical Therapeutic Chemical (ATC) Classes for simvastatin

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

US Patents and Regulatory Information for simvastatin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hetero Labs Ltd Iii	SIMVASTATIN	simvastatin	TABLET;ORAL	200895-005	Nov 25, 2014	AB	RX	No	No
Mylan Pharms Inc	SIMVASTATIN	simvastatin	TABLET;ORAL	090868-003	Jun 8, 2010		DISCN	No	No
Mylan Pharms Inc	SIMVASTATIN	simvastatin	TABLET;ORAL	090868-004	Jun 8, 2010		DISCN	No	No
Lupin	SIMVASTATIN	simvastatin	TABLET;ORAL	078103-001	May 11, 2007	AB	RX	No	No
Sun Pharm Inds Ltd	SIMVASTATIN	simvastatin	TABLET;ORAL	076285-001	Dec 20, 2006		DISCN	No	No
Accord Hlthcare	SIMVASTATIN	simvastatin	TABLET;ORAL	078155-001	Feb 26, 2008	AB	RX	No	No
Watson Labs Teva	SIMVASTATIN	simvastatin	TABLET;ORAL	076685-005	Dec 20, 2006		DISCN	No	No

Expired US Patents for simvastatin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	ZOCOR	simvastatin	TABLET;ORAL	019766-003	Dec 23, 1991
Organon	ZOCOR	simvastatin	TABLET;ORAL	019766-003	Dec 23, 1991
Organon	ZOCOR	simvastatin	TABLET;ORAL	019766-001	Dec 23, 1991
Organon	ZOCOR	simvastatin	TABLET;ORAL	019766-001	Dec 23, 1991
Organon	ZOCOR	simvastatin	TABLET;ORAL	019766-002	Dec 23, 1991
Organon	ZOCOR	simvastatin	TABLET;ORAL	019766-002	Dec 23, 1991
Organon	ZOCOR	simvastatin	TABLET;ORAL	019766-004	Dec 23, 1991

International Patents for simvastatin

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2007125339
Denmark	2018153
China	101431982	Liquid oral compositions
Portugal	2018153
Spain	2385752
Australia	2007245410	Liquid oral compositions
Poland	2018153

Supplementary Protection Certificates for simvastatin

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	26/2005	Austria		PRODUCT NAME: EZETIMIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON KOMBINIERT MIT SIMVASTATIN; NAT. REGISTRATION NO/DATE: 1-25673 - 1-25676 20041228; FIRST REGISTRATION: DE 58874.00.00 - 58874.03.00; 58878.00.00 - 20040402
0720599	05C0040	France		PRODUCT NAME: EZETIMIBE; SIMVASTATINE; NAT. REGISTRATION NO/DATE: NL 31849 20050728; FIRST REGISTRATION: DE - 58 878 00 00 20040402
0720599	SPC/GB05/010	United Kingdom		PRODUCT NAME: EZETIMIBE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH SIMVASTATIN; REGISTERED: DE 58874.00.00 20040402; DE 58874.01.00 20040402; DE 58874.02.00 20040402; DE 58874.03.00 20040402; DE 58878.00.00 20040402; DE 58878.01.00 20040402; DE 58878.02.00 20040402; DE 58878.03.00 20040402; DE 58866.00.00 20040402; DE 58866.01.00 20040402; DE 58866.02.00 20040402; DE 58866.03.00 20040402; DE 58870.00.00 20040402; DE 58870.01.00 20040402; DE 58870.02.00 20040402; DE 58870.03.00 20040402; UK PL 19945/0003 20041118; UK PL 19945/0004 20041118; UK PL 19945/0005 20041118; UK PL 19945/0006 20041118; UK PL 19945/0007 20041118; UK PL 19945/0008 20041118; UK PL 19945/0009 200411
0720599	C300172	Netherlands		PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN SIMVASTATINE; NAT. REGISTRATION NO/DATE: RVG 30927RVG 30928RVG 30929RVG 30930 2004221122; FIRST REGISTRATION: 58874.00.0058874.01.0058874.02.0058874.03.0058878.00.0058878.01.0058878.02.0058878.03.0058866.00.0058866.01.0058866.02.0058866.03.0058870.00.0058870.01.0058870.02.0058870.03.00 2004020402