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Last Updated: November 14, 2019

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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 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, Micro Labs, Mylan Pharms Inc, Oxford Pharms, Sun Pharm Inds Ltd, Watson Labs Teva, Yaopharma Co Ltd, Zydus Pharms Usa, Msd Merck Co, and Merck Sharp Dohme, and is included in nineteen NDAs. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Simvastatin has eleven patent family members in eleven countries.

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

Summary for simvastatin

International Patents:	11
US Patents:	9
Tradenames:	4
Applicants:	19
NDAs:	19
Drug Master File Entries:	40
Suppliers / Packagers:	43
Bulk Api Vendors:	100
Clinical Trials:	484
Patent Applications:	7,051
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for simvastatin
Drug Sales Revenues:	Drug sales revenues for simvastatin
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for simvastatin
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
Rigshospitalet, Denmark	Phase 4
Copenhagen University Hospital, Hvidovre	Phase 4
Aarhus University Hospital	Phase 4

See all simvastatin clinical trials

Recent Litigation for simvastatin

Identify potential future generic entrants

District Court Litigation

Case Name	Date
AstraZeneca UK Limited v. Watson Pharmaceuticals Inc.	2010-10-26
AstraZeneca Pharmaceuticals LP v. Aurobindo Pharma Limited Inc.	2008-06-24
TEVA PHARMACEUTICALS USA, INC. v. LEAVITT	2008-03-04

See all simvastatin litigation

Generic filers with tentative approvals for SIMVASTATIN

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

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-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
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
BPBio1_001001
BRD-K22134346-001-05-8
BRD-K22134346-001-11-6
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
DB00641
Denan
DivK1c_006991
DRG-0320
DSSTox_CID_3581
DSSTox_GSID_23581
DSSTox_RID_77090
DTXSID0023581
Eucor
GTPL2955
HMS1570N11
HMS1922H13
HMS2089D12
HMS2093E06
HMS2097N11
HMS2231N22
HMS3259B12
HMS3714N11
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-0733
MK-733
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
NCGC00017324-09
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
Simlup
Simovil
Simvacor
Simvast CR
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, 98%
Simvastatin, analytical standard
Simvastatin, British Pharmacopoeia (BP) Reference Standard
Simvastatin, Compactin
Simvastatin, European Pharmacopoeia (EP) Reference Standard
Simvastatin, Pharmaceutical Secondary Standard; Certified Reference Material
Simvastatin, United States Pharmacopeia (USP) Reference Standard
Simvastatin,(S)
Simvastatina
Simvastatina [Spanish]
Simvastatine
Simvastatine [French]
Simvastatinum
Simvastatinum [Latin]
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
SR-05000001894-2
ST057168
ST2407853
STK801938
Synvinolin
TNP00259
Tox21_110696
Tox21_110696_1
Tox21_300400
UNII-AGG2FN16EV
Valemia
Vasotenal
Velostatin
W-3044
Z1741982918
ZINC3780893
Zocor
Zocor (TN)
Zocord
Zorced
Zosta

Paragraph IV (Patent) Challenges for SIMVASTATIN

Tradename	Dosage	Ingredient	NDA	Submissiondate
ZOCOR	TABLET;ORAL	simvastatin	019766

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
Yaopharma Co Ltd	SIMVASTATIN	simvastatin	TABLET;ORAL	077766-004	Dec 20, 2006		DISCN	No	No	Start Trial	Start Trial				Start Trial
Hisun Pharm Hangzhou	SIMVASTATIN	simvastatin	TABLET;ORAL	206557-003	Nov 13, 2017		DISCN	No	No	Start Trial	Start Trial				Start Trial
Sun Pharm Inds Ltd	SIMVASTATIN	simvastatin	TABLET;ORAL	076285-003	Dec 20, 2006		DISCN	No	No	Start Trial	Start Trial				Start Trial
>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	Start Trial	Start Trial
Msd Merck Co	ZOCOR	simvastatin	TABLET;ORAL	019766-001	Dec 23, 1991	Start Trial	Start Trial
Msd Merck Co	ZOCOR	simvastatin	TABLET;ORAL	019766-002	Dec 23, 1991	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for simvastatin

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Country	Patent Number	Estimated Expiration
Australia	2007245410	Start Trial
European Patent Office	2018153	Start Trial
China	101431982	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for simvastatin

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0720599	05C0040	France	Start Trial	PRODUCT NAME: EZETIMIBE; SIMVASTATINE; NAT. REGISTRATION NO/DATE: NL 31849 20050728; FIRST REGISTRATION: DE - 58 878 00 00 20040402
0720599	26/2005	Austria	Start Trial	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	122004000026	Germany	Start Trial	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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