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Daiichi Sankyo
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Generated: September 24, 2018

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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.

Pharmacology for simvastatin
Medical Subject Heading (MeSH) Categories for simvastatin
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
➤ Try a Free Trial➤ Try a Free Trial80MGTABLET; ORAL
➤ Try a Free Trial➤ Try a Free Trial40MGTABLET; ORAL
➤ Try a Free Trial➤ Try a Free Trial20MGTABLET; 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 ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Ivax Sub Teva Pharms SIMVASTATIN simvastatin TABLET;ORAL 076052-001 Jun 23, 2006 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Accord Hlthcare SIMVASTATIN simvastatin TABLET;ORAL 078155-004 Feb 26, 2008 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Sun Pharm Inds Ltd SIMVASTATIN simvastatin TABLET;ORAL 076285-005 Jun 23, 2006 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Merck Sharp Dohme JUVISYNC simvastatin; sitagliptin phosphate TABLET;ORAL 202343-001 Oct 7, 2011 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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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 ➤ Try a Free Trial ➤ Try a Free Trial
Msd Merck Co ZOCOR simvastatin TABLET;ORAL 019766-001 Dec 23, 1991 ➤ Try a Free Trial ➤ Try a Free Trial
Msd Merck Co ZOCOR simvastatin TABLET;ORAL 019766-003 Dec 23, 1991 ➤ Try a Free Trial ➤ Try a Free Trial
Msd Merck Co ZOCOR simvastatin TABLET;ORAL 019766-003 Dec 23, 1991 ➤ Try a Free Trial ➤ Try a Free Trial
Msd Merck Co ZOCOR simvastatin TABLET;ORAL 019766-003 Dec 23, 1991 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for simvastatin

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0040 France ➤ Try a Free Trial PRODUCT NAME: EZETIMIBE; SIMVASTATINE; NAT. REGISTRATION NO/DATE: NL 31849 20050728; FIRST REGISTRATION: DE - 58 878 00 00 20040402
00172 Netherlands ➤ Try a Free Trial 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 ➤ Try a Free 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
2004000026 Germany ➤ Try a Free 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
C/GB05/010 United Kingdom ➤ Try a Free Trial 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Healthtrust
Covington
McKesson
Chinese Patent Office
Teva
Cantor Fitzgerald
Express Scripts
Argus Health

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