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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 lovastatin freedom to operate?

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.

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

Summary for lovastatin

US Patents:	1
Tradenames:	3
Applicants:	10
NDAs:	12
Drug Master File Entries:	33
Suppliers / Packagers:	39
Bulk Api Vendors:	83
Clinical Trials:	63
Patent Applications:	6,984
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for lovastatin
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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apotex Inc	LOVASTATIN	lovastatin	TABLET;ORAL	077748-002	Feb 28, 2007	AB	RX	No	No
Carlsbad	LOVASTATIN	lovastatin	TABLET;ORAL	075991-001	Jun 5, 2002	AB	RX	No	No
Covis Pharma Bv	ALTOPREV	lovastatin	TABLET, EXTENDED RELEASE;ORAL	021316-003	Jun 26, 2002		RX	Yes	No
Lupin	LOVASTATIN	lovastatin	TABLET;ORAL	078296-002	Nov 1, 2007	AB	RX	No	No

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
Covis Pharma Bv	ALTOPREV	lovastatin	TABLET, EXTENDED RELEASE;ORAL	021316-001	Jun 26, 2002
Covis Pharma Bv	ALTOPREV	lovastatin	TABLET, EXTENDED RELEASE;ORAL	021316-002	Jun 26, 2002
Covis Pharma Bv	ALTOPREV	lovastatin	TABLET, EXTENDED RELEASE;ORAL	021316-004	Jun 26, 2002

International Patents for lovastatin

Country	Document Number	Estimated Expiration
Canada	2324999
World Intellectual Property Organization (WIPO)	9948488
Japan	2002507564
Australia	759257