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Simvastatin - Generic Drug Details

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 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:	60
Bulk Api Vendors:	91
Clinical Trials:	465
Patent Applications:	7,398
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
➤ Sign Up	➤ Sign Up	40MG	TABLET; ORAL
➤ Sign Up	➤ Sign Up	20MG	TABLET; ORAL
➤ Sign Up	➤ Sign Up	10MG	TABLET; ORAL

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
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-001	Oct 7, 2011		DISCN	Yes	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-002	Oct 7, 2011		DISCN	Yes	No	➤ Sign Up	➤ Sign Up	Y	Y		➤ Sign Up
Biocon Limited	SIMVASTATIN	simvastatin	TABLET;ORAL	078034-002	Dec 20, 2006	AB	RX	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Yaopharma Co Ltd	SIMVASTATIN	simvastatin	TABLET;ORAL	077766-001	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
Msd Merck Co	ZOCOR	simvastatin	TABLET;ORAL	019766-003	Dec 23, 1991	➤ Sign Up	➤ Sign Up
Msd Merck Co	ZOCOR	simvastatin	TABLET;ORAL	019766-001	Dec 23, 1991	➤ Sign Up	➤ Sign Up
Msd Merck Co	ZOCOR	simvastatin	TABLET;ORAL	019766-002	Dec 23, 1991	➤ Sign Up	➤ Sign Up
Msd Merck Co	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	Document Number	Estimated Expiration
Australia	2007245410	➤ Sign Up
European Patent Office	2018153	➤ Sign Up
China	101431982	➤ Sign Up
Japan	2009534459	➤ Sign Up
Country	Document Number	Estimated Expiration

Supplementary Protection Certificates for simvastatin

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Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C0040	France	➤ Sign Up	PRODUCT NAME: EZETIMIBE; SIMVASTATINE; NAT. REGISTRATION NO/DATE: NL 31849 20050728; FIRST REGISTRATION: DE - 58 878 00 00 20040402
/2005	Austria	➤ Sign Up	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
00172	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
2004000026	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
Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description