Simvastatin - Generic Drug Details

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What are the generic drug sources for simvastatin and what is the scope of patent protection?

Simvastatin is the generic ingredient in four branded drugs marketed by Salerno Pharms, 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:	583
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

Drug Sales Revenue Trends for simvastatin

See drug sales revenues for simvastatin

Recent Clinical Trials for simvastatin

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

Sponsor	Phase
International Bio service	Phase 1
State University of New York - Downstate Medical Center	Phase 1/Phase 2
United States Department of Defense	Early Phase 1

See all simvastatin clinical trials

Generic filers with tentative approvals for SIMVASTATIN

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	10MG	TABLET; ORAL
⤷ Sign Up	⤷ Sign Up	5MG	TABLET; ORAL
⤷ Sign Up	⤷ Sign Up	80MG	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

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Glossary

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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
Mylan Pharms Inc	SIMVASTATIN	simvastatin	TABLET;ORAL	090868-003	Jun 8, 2010		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Accord Hlthcare	SIMVASTATIN	simvastatin	TABLET;ORAL	078155-002	Feb 26, 2008	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Watson Labs Teva	SIMVASTATIN	simvastatin	TABLET;ORAL	076685-003	Dec 20, 2006		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for simvastatin

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	ZOCOR	simvastatin	TABLET;ORAL	019766-002	Dec 23, 1991	⤷ Sign Up	⤷ Sign Up
Organon	ZOCOR	simvastatin	TABLET;ORAL	019766-005	Jul 10, 1998	⤷ Sign Up	⤷ Sign Up
Organon	ZOCOR	simvastatin	TABLET;ORAL	019766-004	Dec 23, 1991	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for simvastatin

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Country	Patent Number	Title	Estimated Expiration
Poland	2018153		⤷ Sign Up
Portugal	2018153		⤷ Sign Up
Slovenia	2018153		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for simvastatin

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0720599	C300172	Netherlands	⤷ Sign Up	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
0720599	122004000026	Germany	⤷ Sign Up	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	05C0040	France	⤷ Sign Up	PRODUCT NAME: EZETIMIBE; SIMVASTATINE; NAT. REGISTRATION NO/DATE: NL 31849 20050728; FIRST REGISTRATION: DE - 58 878 00 00 20040402
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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