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Lovastatin - Generic Drug Details

What are the generic sources for lovastatin and what is the scope of lovastatin patent protection?
Lovastatin is the generic ingredient in three branded drugs marketed by Covis Pharma Bv, Actavis Elizabeth, Apotex Inc, Carlsbad, Lupin, Mylan, Sandoz, Sun Pharm Industries, Teva, and Merck, and is included in twelve NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Lovastatin has seven patent family members in five countries.

There are thirty-three drug master file entries for lovastatin. Forty-two suppliers are listed for this compound.

Summary for lovastatin

International Patents:	7
US Patents:	1
Tradenames:	3
Applicants:	10
NDAs:	12
Drug Master File Entries:	33
Suppliers / Packagers:	42
Bulk Api Vendors:	81
Clinical Trials:	59
Patent Applications:	6,986
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for lovastatin
DailyMed Link:	lovastatin at DailyMed

Pharmacology for lovastatin

Drug Class	HMG-CoA Reductase Inhibitor
Mechanism of Action	Hydroxymethylglutaryl-CoA Reductase Inhibitors

Medical Subject Heading (MeSH) Categories for lovastatin

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Synonyms for lovastatin

(+)-mevinolin
(1S-(1alpha(R),3alpha,7beta,8beta(2S,4S*),8abeta))-2-Methylbutanoic acid 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,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 (S)-2-methyl-butyrate
(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 (S)-2-methylbutanoate
(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 (2S)-2-methylbutanoate
(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 (2S)-2-methylbutanoate
(2S)-(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-2-methyl butanoate
(2S)-2-Methylbutanoic 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
(2S)-2-methylbutanoic acid [(1S,3R,7S,8S,8aR)-8-[2-[(2R,4R)-4-hydroxy-6-oxo-2-oxanyl]ethyl]-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl] ester
(S)-((1S,3R,7S,8S,8AR)-8-(2-((2R,4R)-4-HYDROXY-6-OXO-TETRAHYDRO-2H-PYRAN-2-YL)ETHYL)-3,7-DIMETHYL-1,2,3,7,8,8A-HEXAHYDRONAPHTHALEN-1-YL) 2-METHYLBUTANOATE
(S)-2-Methyl-butyric acid (1S,3R,7S,8S,8aR)-8-[2-((3R,5R)-4-hydroxy-6-oxo-tetrahydro-pyran-2-yl)-ethyl]-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl ester
(S)-2-Methylbutyric 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
[(1S,3R,7S,8S,8aR)-3,7-dimethyl-8-[2-[(2R,4R)-4-oxidanyl-6-oxidanylidene-oxan-2-yl]ethyl]-1,2,3,7,8,8a-hexahydronaphthalen-1-yl] (2S)-2-methylbutanoate
[(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] (2S)-2-methylbutanoate
[(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] (2S)-2-methylbutanoate
1,2,6,7,8,8a-Hexahydro-beta,delta-dihydroxy-2,6-dimethyl-8-(2-methyl-1-oxobutyoxy)-1-naphthaleneheptanoic acid delta-lactone
117141-EP2272825A2
117141-EP2298776A1
1cqp
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 (2S)-2-methylbutanoate
2-Methyl-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 butanoic acid
28048-EP2269989A1
28048-EP2270011A1
28048-EP2272825A2
28048-EP2272841A1
28048-EP2277507A1
28048-EP2277865A1
28048-EP2280006A1
28048-EP2281813A1
28048-EP2284158A1
28048-EP2286795A1
28048-EP2287165A2
28048-EP2287166A2
28048-EP2289892A1
28048-EP2292620A2
28048-EP2295406A1
28048-EP2295409A1
28048-EP2298742A1
28048-EP2298745A1
28048-EP2298772A1
28048-EP2298776A1
28048-EP2298779A1
28048-EP2301923A1
28048-EP2301931A1
28048-EP2301936A1
28048-EP2305648A1
28048-EP2308839A1
28048-EP2311808A1
28048-EP2311829A1
28048-EP2314588A1
2beta,6alpha-Dimethyl-8alpha-(2-methyl-1-oxobutoxy)-mevinic acid lactone
330L755
6 alpha-Methylcompactin
6 Methylcompactin
6-alpha-Methylcompactin
6-Methylcompactin
6alpha-Methylcompactin
71949-96-7
74133-25-8
75330-75-5
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 (2S)-2-methylbutanoate
8-[2-(4-Hydroxy-6-oxotetrahydro-2H-pyran-2-yl)ethyl]-3,7-dimethyl-1,2,3,7,8,8a-hexahydro-1-naphthalenyl 2-methylbutanoate
81739-26-6
96638-EP2287163A1
96638-EP2305678A1
9LHU78OQFD
A838030
AB00052400_18
AB00052400_19
AB00052400-17
AB0108514
AC-13961
AC1L1EI6
AC1Q2C7T
ACon0_000534
ACon1_000390
ACT02620
Advicor (TN)
AKOS005267139
ALBB-027272
Altocor
Altocor (TN)
Altoprev
Altoprev (TN)
ANW-41686
AOB5269
ARONIS24208
Artein
BB_NC-01457
BB_NC-1457
BBL024473
BDBM34168
Belvas
BG0243
BIDD:GT0749
BIDD:PXR0113
BPBio1_000519
BRD-K09416995-001-06-8
BRN 3631989
BSPBio_000471
BSPBio_001265
BSPBio_003346
Butanoic acid, 2-methyl-, (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, (2S)-
Butanoic acid, 2-methyl-, (1S,3R,7S,8S,8aR)-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, (2S)-
butanoic acid, 2-methyl-, (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, (2S)-
Butanoic acid, 2-methyl-, 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(R),3alpha,7beta,8beta(2S,4S*),8abeta))-
Butanoic acid, 2-methyl-, 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-(R),3-alpha,7-beta,8-beta-(2S,4S*),8a-beta))-
Butanoic acid, 2-methyl-, 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(R),3alpha,7beta,8beta(2S,4S*),8abeta))-
Butanoic acid, 2-methyl-,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(R),3alpha,7beta,8beta(2S,4S*),8abeta))
C-21799
C07074
C24H36O5
CAS-75330-75-5
CC-30040
CC-30041
CCG-39627
CCRIS 8092
CHEBI:40303
CHEMBL503
Cholestra
cid_53232
CJ-10768
Closterol
Colevix
CPD000673570
CS-1990
CTK2H7081
D00359
D06WTZ
DB00227
DivK1c_001032
DR002391
DSSTox_CID_784
DSSTox_GSID_20784
DSSTox_RID_75788
DTXSID5020784
EBD2126857
EN300-52515
G226
GTPL2739
HE113887
HE386048
HE391445
Hipolip
Hipovastin
HMS1569H13
HMS1792O07
HMS1923O13
HMS1990O07
HMS2089M06
HMS2093O03
HMS2096H13
HMS2236F07
HMS3039N16
HMS3259F10
HMS3268C03
HMS3403O07
HMS503O05
HSDB 6534
HY-N0504
I06-1876
IDI1_001032
J10136
KBio1_001032
KBio3_002848
KS-1082
KSC377A8D
L-154803
L0214
Lestatin
Lipdip
Lipivas
Lipofren
Liposcler
lostatin
Lovalip
Lovalord
Lovastatin (Mevacor)
Lovastatin (MK-803)
Lovastatin (USP/INN)
Lovastatin [USAN:BAN:INN]
Lovastatin [USAN]
Lovastatin & Primycin
Lovastatin, (1 alpha(S*))-Isomer
Lovastatin, 1 alpha-Isomer (without R/S notation)
Lovastatin, 97% 5g
Lovastatina
Lovastatina [Spanish]
Lovastatine
Lovastatine [French]
Lovastatinum
Lovastatinum [Latin]
Lovasterol
Lovastin
Lozutin
LS-46359
MCULE-4740518260
MCULE-7087866108
MEGxm0_000398
Mevacor
Mevacor (TN)
Mevinacor
mevinolin
Mevinolin from Aspergillus sp.
Mevinolin from Aspergillus sp., >=98% (HPLC)
Mevinolin from Aspergillus sp., powder
Mevlor
MFCD00072164
MK 803
MK-803
MK803
ML-530B
MLS000069585
MLS001055358
MLS006011867
MolPort-001-739-990
Monacolin K
Monakolin K
MSD 803
N1632
NC00713
NCGC00023509-03
NCGC00023509-04
NCGC00023509-05
NCGC00023509-06
NCGC00023509-07
NCGC00023509-08
NCGC00023509-09
NCGC00023509-10
NCGC00023509-11
NCGC00023509-13
NCGC00023509-14
NCGC00254157-01
NCGC00259026-01
Nergadan
NINDS_001032
NSC-633781
NSC-758662
NSC633781
NSC758662
Opera_ID_1578
Paschol
PCZOHLXUXFIOCF-BXMDZJJMSA-N
Pharmakon1600-01503977
Prestwick_819
Prestwick0_000516
Prestwick1_000516
Prestwick2_000516
Prestwick3_000516
Rextat
Rodatin
Rovacor
RTR-031803
S-7779
s2061
SAM002589904
SAM002589963
SBB080686
SBI-0051881.P002
SC-11968
SCHEMBL14227102
SCHEMBL3136
Sivlor
SMR000058779
SMR000673570
SPBio_002392
SPECTRUM1503977
Spectrum3_001873
Spectrum5_001294
SR-01000000123
SR-01000000123-3
Statosan (TN)
STK801953
Taucor
Tecnolip
Teroltrat
Tox21_110888
Tox21_110888_1
Tox21_201475
Tox21_300268
UNII-9LHU78OQFD
Z1258578375
ZINC3812841

US Patents and Regulatory Information for lovastatin

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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
Sandoz	LOVASTATIN	lovastatin	TABLET;ORAL	075300-003	Dec 17, 2001	AB	RX	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Mylan	LOVASTATIN	lovastatin	TABLET;ORAL	075935-001	Dec 17, 2001		DISCN	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Sandoz	LOVASTATIN	lovastatin	TABLET;ORAL	075636-002	Dec 17, 2001	AB	RX	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Covis Pharma Bv	ALTOPREV	lovastatin	TABLET, EXTENDED RELEASE;ORAL	021316-004	Jun 26, 2002		RX	Yes	Yes	➤ 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

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Expired US Patents for lovastatin

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Covis Pharma Bv	ALTOPREV	lovastatin	TABLET, EXTENDED RELEASE;ORAL	021316-003	Jun 26, 2002	➤ Sign Up	➤ Sign Up
Covis Pharma Bv	ALTOPREV	lovastatin	TABLET, EXTENDED RELEASE;ORAL	021316-001	Jun 26, 2002	➤ Sign Up	➤ Sign Up
Covis Pharma Bv	ALTOPREV	lovastatin	TABLET, EXTENDED RELEASE;ORAL	021316-001	Jun 26, 2002	➤ Sign Up	➤ Sign Up
Covis Pharma Bv	ALTOPREV	lovastatin	TABLET, EXTENDED RELEASE;ORAL	021316-002	Jun 26, 2002	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

Non-Orange Book US Patents for lovastatin

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

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Patent No.	Title	Estimated Patent Expiration
6,440,387	Methods for determining risk of Alzheimer's disease	➤ Sign Up
Patent No.	Title	Estimated Patent Expiration