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Lovastatin - Generic Drug Details
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What are the generic sources for lovastatin and what is the scope of patent protection?
Lovastatin
is the generic ingredient in three branded drugs marketed by Covis Pharma Bv, Actavis Elizabeth, Apotex Inc, Beximco Pharms Usa, Carlsbad, Lupin, Mylan, Sandoz, Sun Pharm Industries, Teva, and Merck, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.There are thirty-three drug master file entries for lovastatin. Thirty-three suppliers are listed for this compound.
Summary for lovastatin
Recent Clinical Trials for lovastatin
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Coimbra | N/A |
Synthetic Biologics Inc. | Phase 2 |
Cedars-Sinai Medical Center | Phase 2 |
Recent Litigation for lovastatin
Identify potential future generic entrants
District Court Litigation
Case Name | Date |
---|---|
AstraZeneca Pharmaceuticals LP v. Sun Pharmaceutical Industries Ltd. | 2007-12-11 |
Pfizer Inc. v. Ranbaxy Laboratories Limited | 2007-03-09 |
Pharmacology for lovastatin
Drug Class | HMG-CoA Reductase Inhibitor |
Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for lovastatin
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)-1,2,3,7,8,8a-Hexahydro-8-(2-((4R,6R)-4-hydroxy-2-oxo-2H-pyran-6-yl)ethyl)-3,7-dimethylnaphtyl(S)-2-methylbutyrat |
(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)-((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-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-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 |
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 |
AKOS005267139 |
ALBB-027272 |
Altocor |
Altoprev |
ANW-41686 |
AOB5269 |
ARONIS24208 |
Artein |
BB_NC-01457 |
BBL024473 |
BDBM34168 |
Belvas |
BG0243 |
BIDD:GT0749 |
BIDD:PXR0113 |
BPBio1_000519 |
BRD-K09416995-001-06-8 |
BRD-K09416995-001-21-7 |
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 |
DB00227 |
DivK1c_001032 |
DSSTox_CID_784 |
DSSTox_GSID_20784 |
DSSTox_RID_75788 |
DTXSID5020784 |
EBD2126857 |
EC 616-212-7 |
EN300-52515 |
G226 |
GTPL2739 |
Hipolip |
Hipovastin |
HMS1569H13 |
HMS1792O07 |
HMS1923O13 |
HMS1990O07 |
HMS2089M06 |
HMS2093O03 |
HMS2096H13 |
HMS2236F07 |
HMS3039N16 |
HMS3259F10 |
HMS3268C03 |
HMS3403O07 |
HMS3713H13 |
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 |
Lovalip |
Lovalord |
Lovastatin (Mevacor) |
Lovastatin (Mevinolin) |
Lovastatin (MK-803) |
Lovastatin (USP/INN) |
Lovastatin [USAN:BAN:INN] |
Lovastatin [USAN:USP:INN:BAN] |
Lovastatin [USAN] |
Lovastatin & Primycin |
Lovastatin, 98% |
Lovastatin,(S) |
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., >=98% (HPLC) |
Mevinolin from Aspergillus sp., powder |
Mevlor |
MFCD00072164 |
MK 803 |
MK-803 |
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 |
NCGC00023509-16 |
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 |
SR-05000001880 |
SR-05000001880-1 |
SR-05000001880-2 |
STK801953 |
Taucor |
Tecnolip |
Teroltrat |
Tox21_110888 |
Tox21_110888_1 |
Tox21_201475 |
Tox21_300268 |
UNII-9LHU78OQFD |
US9115116, lovastatin |
US9353061, Lovastatina |
Z1258578375 |
ZINC3812841 |
US Patents and Regulatory Information for lovastatin
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mylan | LOVASTATIN | lovastatin | TABLET;ORAL | 075451-001 | Dec 17, 2001 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Merck | MEVACOR | lovastatin | TABLET;ORAL | 019643-002 | Mar 28, 1991 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
Sun Pharm Industries | LOVASTATIN | lovastatin | TABLET;ORAL | 077520-002 | Apr 14, 2006 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Lupin | LOVASTATIN | lovastatin | TABLET;ORAL | 078296-001 | Mar 14, 2008 | AB | RX | 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 lovastatin
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 | Start Trial | Start Trial |
Merck | MEVACOR | lovastatin | TABLET;ORAL | 019643-004 | Dec 14, 1988 | Start Trial | Start Trial |
Covis Pharma Bv | ALTOPREV | lovastatin | TABLET, EXTENDED RELEASE;ORAL | 021316-004 | Jun 26, 2002 | Start Trial | Start Trial |
Covis Pharma Bv | ALTOPREV | lovastatin | TABLET, EXTENDED RELEASE;ORAL | 021316-001 | Jun 26, 2002 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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