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Simvastatin - Generic Drug Details

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

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

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

Summary for simvastatin

US Patents:	8
Tradenames:	4
Applicants:	19
NDAs:	19
Drug Master File Entries:	40
Suppliers / Packagers:	62
Bulk Api Vendors:	91
Clinical Trials:	451
Patent Applications:	7,358
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for simvastatin
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for simvastatin
DailyMed Link:	simvastatin at DailyMed

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

Synonyms for simvastatin

(+)-Simvastatin

(1S,3R,7S,8S,8aR)-1,2,3,7,8,8a-Hexahydro-3,7-dimethyl-8-[2-[(2R,4R)-tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl]ethyl]-1-naphthalenyly-2,2-dimethyl butanoate

(1S,3R,7S,8S,8aR)-8-(2-((2R,4R)-4-Hydroxy-6-oxotetrahydro-2H-pyran-2-yl)ethyl)-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl 2,2-dimethylbu

(1S,3R,7S,8S,8aR)-8-(2-((2R,4R)-4-Hydroxy-6-oxotetrahydro-2H-pyran-2-yl)ethyl)-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl 2,2-dimethylbutanoate

(1S,3R,7S,8S,8aR)-8-{2-[(2R,4R)-4-hydroxy-6-oxooxan-2-yl]ethyl}-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl 2,2-dimethylbutanoate

(1S,3R,7S,8S,8aR)-8-{2-[(2R,4R)-4-hydroxy-6-oxotetrahydro-2H-pyran-2-yl]ethyl}-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl 2,2-dimethylbutanoate

(1S,7S,8S,8aR)-8-{2-[(2R,4R)-4-hydroxy-6-oxooxan-2-yl]ethyl}-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl 2,2-dimethylbutanoate

[(1S,3R,7S,8S,8aR)-8-[2-[(2R,4R)-4-hydroxy-6-oxo-tetrahydropyran-2-yl]ethyl]-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl] 2,2-dimethylbutanoate

[(1S,3R,7S,8S,8aR)-8-[2-[(2R,4R)-4-hydroxy-6-oxooxan-2-yl]ethyl]-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl] 2,2-dimethylbutanoate

2,?2-?DIMETHYL-?1S,?2,?3R,?7S,?8S,?8AR-?HEXAHYDRO-?3,?7-?DIMETHYL-?8-?[2-?[(2R,?4R)-?TETRAHYDRO-?4-?HYDROXY-?6-?OXO-?2H-?PYRAN-?2-?YL]ETHYL]-?1-?NAPHTHALENYL ESTER,? BUTANOIC ACID

2,2-Dimethylbutanoic acid (1S,3R,7S,8S,8aR)-1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-[(2R,4R)-tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl]ethyl]-1-naphthalenyl ester

2,2-Dimethylbutyric acid, 8-ester with (4R,6R)-6-(2-((1S,2S,6R,8S,8aR)-1,2,6,7,8,8a-hexahydro-8-hydroxy-2,6-dimethyl-1-naphthyl)ethyl)tetrahydro-4-hydroxy-2H-pyran-2-one

28049-EP2269989A1

28049-EP2269990A1

28049-EP2270011A1

28049-EP2270505A1

28049-EP2272825A2

28049-EP2272841A1

28049-EP2277865A1

28049-EP2280001A1

28049-EP2280006A1

28049-EP2281813A1

28049-EP2284158A1

28049-EP2287165A2

28049-EP2287166A2

28049-EP2292620A2

28049-EP2295406A1

28049-EP2295409A1

28049-EP2295417A1

28049-EP2295422A2

28049-EP2298731A1

28049-EP2298742A1

28049-EP2298745A1

28049-EP2298769A1

28049-EP2298772A1

28049-EP2298776A1

28049-EP2298779A1

28049-EP2301923A1

28049-EP2301931A1

28049-EP2301936A1

28049-EP2305219A1

28049-EP2305648A1

28049-EP2308839A1

28049-EP2308878A2

28049-EP2314588A1

79902-63-9

8-[2-((2R,4R)-4-hydroxy-6-oxo(2H-3,4,5-trihydropyran-2-yl))ethyl](1S,7S,8S,3R, 8aR)-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthyl 2,2-dimethylbutanoate

8-[2-(4-hydroxy-6-oxotetrahydro-2H-pyran-2-yl)ethyl]-3,7-dimethyl-1,2,3,7,8,8a-hexahydro-1-naphthalenyl 2,2-dimethylbutanoate

902S639

96639-EP2287163A1

96639-EP2305678A1

99548-EP2270011A1

99548-EP2298779A1

99548-EP2301923A1

99548-EP2301931A1

AB00053395_11

AB00053395_13

AB00053395-07

AB00053395-08

AB00053395-10

AB0069097

AC-1530

AC1L1H1F

AGG2FN16EV

AJ-45588

AK-48916

AKOS005111006

AKOS015842733

AN-7250

ARONIS24119

AT-7048

BBL024390

BC203244

BCBcMAP01_000007

BDBM50139181

BIDD:GT0769

Bio-0672

BPBio1_001001

BRD-K22134346-001-05-8

BRD-K22134346-001-15-7

BRN 4768037

BSPBio_000909

BSPBio_002337

Butanoic acid, 2,2-dimethyl-, (1S,3R,7S,8S,*aR)-1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-(2-((2R,4R)-tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)ethyl)-1-naphthalenyl ester

Butanoic acid, 2,2-dimethyl-, (1S,3R,7S,8S,8aR)-1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-(2-((2R,4R)-tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)ethyl)-1-naphthalenyl ester

Butanoic acid, 2,2-dimethyl-, (1S,3R,7S,8S,8aR)-1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-[(2R,4R)-tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl]ethyl]-1-naphthalenyl ester

Butanoic acid, 2,2-dimethyl-, 1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-(2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)ethyl)-1-naphthalenyl ester, (1S-(1alpha,3alpha,7beta,8beta(2S*,4S*),8abeta))-

butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1 alpha,3 alpha,7 beta,8 beta(2S*,4S*),-8a beta

C25H38O5

CAS-79902-63-9

CCG-39069

CCRIS 7558

CHEBI:9150

CHEMBL1064

Cholestat

Coledis

Colemin

Corolin

CPD000718785

CS-2269

D00434

D0H0ND

DB00641

Denan

DivK1c_006991

DR002559

DRG-0320

DSSTox_CID_3581

DSSTox_GSID_23581

DSSTox_RID_77090

DTXSID0023581

Eucor

GTPL2955

HE153298

HE390056

HMS1570N11

HMS1922H13

HMS2089D12

HMS2093E06

HMS2097N11

HMS2231N22

HMS3259B12

HSDB 7208

HY-17502

inactive simvastatin

InChI=1/C25H38O5/c1-6-25(4,5)24(28)30-21-12-15(2)11-17-8-7-16(3)20(23(17)21)10-9-19-13-18(26)14-22(27)29-19/h7-8,11,15-16,18-21,23,26H,6,9-10,12-14H2,1-5H3/t15-,16-,18+,19+,20-,21-,23-/m0/s1

J10128

KBio1_001935

KBio2_002197

KBio2_004765

KBio2_007333

KBio3_001557

KBioGR_001244

KBioSS_002197

Kolestevan

KS-1113

L 644128-000U

Labistatin

Lipex

Lipinorm

Lipovas

Lodales

LS-46264

MCULE-8390617062

Medipo

MFCD00072007

MK 0733

MK 733

MK-0733

MK-733

MK733

MLS001304029

MLS001333077

MLS001333078

MLS002154038

MLS006011866

Modutrol

MolPort-002-507-345

MRF-0000729

NC00719

NCGC00016940-01

NCGC00017324-01

NCGC00017324-02

NCGC00017324-03

NCGC00017324-04

NCGC00017324-05

NCGC00017324-07

NCGC00017324-08

NCGC00254418-01

Nivelipol

Nor-Vastina

NSC-633782

NSC-758706

NSC633782

NSC758706

Pantok

Pharmakon1600-01504236

Prestwick_171

Prestwick0_000865

Prestwick1_000865

Prestwick2_000865

Prestwick3_000865

Rechol

Rendapid

RYMZZMVNJRMUDD-HGQWONQESA-

RYMZZMVNJRMUDD-HGQWONQESA-N

s1792

SAM002589969

SBB080618

SBI-0206773.P001

SC-12666

SCHEMBL2471

Simcard

Simcard (TN)

Simlup

Simlup (TN)

Simovil

Simvacor

Simvacor (TN)

Simvast CR

Simvastatin (JAN/USP/INN)

Simvastatin (JP17/USP/INN)

Simvastatin (Zocor)

Simvastatin [USAN:INN:BAN]

Simvastatin [USAN:USP:INN:BAN]

Simvastatin & Primycin

Simvastatin for peak identification, European Pharmacopoeia (EP) Reference Standard

Simvastatin lactone

simvastatin predrug

Simvastatin, >=97% (HPLC), solid

Simvastatin, analytical standard

Simvastatin, British Pharmacopoeia (BP) Reference Standard

Simvastatin, Compactin

Simvastatin, European Pharmacopoeia (EP) Reference Standard

Simvastatin, pharmaceutical secondary standard; traceable to USP, PhEur, BP

Simvastatin, United States Pharmacopeia (USP) Reference Standard

Simvastatina

Simvastatina [Spanish]

Simvastatine

Simvastatine [French]

Simvastatinum

Simvastatinum [Latin]

simvastol

Simvoget

Simvotin

Sinvacor

Sinvascor

Sivastin

SMR000718785

SPBio_001881

SPBio_002830

SpecPlus_000895

Spectrum_001717

SPECTRUM1504236

Spectrum2_001671

Spectrum3_000669

Spectrum4_000632

Spectrum5_001428

SR-05000001894

SR-05000001894-1

ST057168

ST2407853

STK801938

Synvinolin

TNP00259

Tox21_110696

Tox21_110696_1

Tox21_300400

UNII-AGG2FN16EV

Valemia

Vasotenal

Velostatin

W-3044

Z1741982918

ZINC3780893

Zocor

Zocor (TN)

Zocor, Simlup, Simcard, Simvacor, Simvoget, Zorced, Simvastatin

Zocord

Zorced

Zosta

Tentative approvals for SIMVASTATIN

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

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
Yaopharma Co Ltd	SIMVASTATIN	simvastatin	TABLET;ORAL	077766-002	Dec 20, 2006		DISCN	No	No
Ivax Sub Teva Pharms	SIMVASTATIN	simvastatin	TABLET;ORAL	076052-001	Jun 23, 2006	AB	RX	No	No
Accord Hlthcare	SIMVASTATIN	simvastatin	TABLET;ORAL	078155-004	Feb 26, 2008	AB	RX	No	No
Sun Pharm Inds Ltd	SIMVASTATIN	simvastatin	TABLET;ORAL	076285-005	Jun 23, 2006		DISCN	No	No
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-001	Oct 7, 2011		DISCN	Yes	No

Expired US Patents for simvastatin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Msd Merck Co	ZOCOR	simvastatin	TABLET;ORAL	019766-005	Jul 10, 1998
Msd Merck Co	ZOCOR	simvastatin	TABLET;ORAL	019766-001	Dec 23, 1991
Msd Merck Co	ZOCOR	simvastatin	TABLET;ORAL	019766-003	Dec 23, 1991
Msd Merck Co	ZOCOR	simvastatin	TABLET;ORAL	019766-003	Dec 23, 1991
Msd Merck Co	ZOCOR	simvastatin	TABLET;ORAL	019766-003	Dec 23, 1991

International Patents for simvastatin

Country	Document Number	Estimated Expiration
Portugal	2018153
Spain	2385752
Australia	2007245410
Cyprus	1112917
World Intellectual Property Organization (WIPO)	2007125339

Supplementary Protection Certificates for simvastatin

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C0040	France		PRODUCT NAME: EZETIMIBE; SIMVASTATINE; NAT. REGISTRATION NO/DATE: NL 31849 20050728; FIRST REGISTRATION: DE - 58 878 00 00 20040402
00172	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
/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
2004000026	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
C/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