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MEVACOR

NDA

LOVASTATIN | N019643 | MERCK RESEARCH LABORATORIES DIV MERCK CO INC

3 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov, 1 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
Interventions for Reading Disabilities in NF1 NCT02964884	Phase 2	Active	Vanderbilt University	120	2016-11 → 2027-01

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain10 active DMFs19 inactive

8 active API suppliers hold Drug Master Files for this ingredient.

TEVA PHARMACEUTICAL INDUSTRIES LTDLOVASTATIN USP

DMF 115021995

ZHEJIANG HISUN PHARMACEUTICAL CO LTDLOVASTATIN USP

DMF 121331996

LUPIN LTDLOVASTATIN USP

DMF 173532004

CONCORD BIOTECH LTDLOVASTATIN USP

DMF 173932004

LUPIN LTDLOVASTATIN TECHNICAL

DMF 177372004

LIVZON GROUP (NINGXIA) PHARMACEUTICAL CO LTDLOVASTATIN (NON-STERILE, BULK FORM)

DMF 185392005

ZHEJIANG APELOA KANGYU PHARMACEUTICAL CO LTDLOVASTATIN USP, NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT

DMF 192172006

CHONGQING DAXIN PHARMACEUTICAL CO LTDLOVASTATIN

DMF 200612006

STERLING BIOTECH LTDLOVASTATIN(API)

DMF 248592011

CHONGQING DAXIN PHARMACEUTICAL CO LTDLOVASTATIN

DMF 354312020

ANTIBIOTIC COInactiveLOVASTATIN

DMF 113361996

ZHEJIANG RUIBANG LABORATORIES INCInactiveLOVASTATIN

DMF 124001997

SYNGEN BIOTECH CO LTDInactiveLOVASTATIN

DMF 124811997

RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPAInactiveLOVASTATIN

DMF 139171998

YUNG SHIN PHARMACEUTICAL INDUSTRIES CO LTDInactiveLOVASTATIN

DMF 140491999

LEK PHARMACEUTICAL AND CHEMICAL CO DDInactiveLOVASTATIN ACTIVE DRUG SUBSTANCE

DMF 144021999

RANBAXY LABORATORIES LTDInactiveLOVASTATIN USP

DMF 144701999

RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPAInactiveLOVASTATIN

DMF 147842000

BIOCON LTDInactiveLOVASTATIN USP

DMF 149122000

BIOCON INDIA LTDInactiveLOVASTATIN TECHNICAL(SFP)

DMF 160952002

ERCROS INDUSTRIAL SA FYSEInactiveLOVASTATIN (TECHNICAL GRADE)

DMF 169012003

ERCROS SAInactiveLOVASTATIN

DMF 170692004

KREBS BIOCHEMICALS INDUSTRIES LTDInactiveLOVASTATIN USP

DMF 171742004

LUPIN LTDInactiveLOVASTATIN

DMF 173102004

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDInactiveLOVASTATIN

DMF 174982004

LEK PHARMACEUTICALS DDInactiveLOVASTATIN

DMF 176622004

ZHEJIANG RUIBANG LABORATORIES INCInactiveLOVASTATIN USP

DMF 181882005

SANDOZ INDUSTRIAL PRODUCTS SPAInactiveLOVASTATIN DRUG SUBSTANCE INTERMEDIATE

DMF 193992006

ALEMBIC LTDInactiveLOVASTATIN USP

DMF 280582014

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

17 letters from Drugs@FDA

Date	Submission	Document
Feb 28, 2014	SUPPL -88	View Letter (PDF)
Nov 5, 2012	SUPPL -87	View Letter (PDF)
Nov 5, 2012	SUPPL -86	View Letter (PDF)
Feb 28, 2012	SUPPL -85	View Letter (PDF)
Jun 17, 2011	SUPPL -82	View Letter (PDF)
Feb 7, 2011	SUPPL -84	View Letter (PDF)
Jul 2, 2010	SUPPL -81	View Letter (PDF)
Mar 11, 2009	SUPPL -80	View Letter (PDF)
Jan 9, 2008	SUPPL -79	View Letter (PDF)
Jun 4, 2007	SUPPL -78	View Letter (PDF)
Apr 25, 2007	SUPPL -61	View Letter (PDF)
Nov 18, 2005	SUPPL -76	View Letter (PDF)
Jun 14, 2005	SUPPL -77	View Letter (PDF)
Apr 12, 2005	SUPPL -75	View Letter (PDF)
Sep 20, 2002	SUPPL -71	View Letter (PDF)
Feb 14, 2002	SUPPL -67	View Letter (PDF)
Mar 11, 1999	SUPPL -55	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#002 — 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Mar 28, 1991

No patent or exclusivity listings for this strength.

#003 — 20MG **Federal Register notice that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Aug 31, 1987

#004 — 40MG **Federal Register notice that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 14, 1988