Viewing data from:

LOVASTATIN

ANDA

LOVASTATIN | A075300 | CHARTWELL RX SCIENCES LLC

3 strengths0 unique patents0 unique exclusivities

Medicare Part D Spending

CMS annual spending data for Lovastatin (2023)

Total Spending

$38.3M

Total Claims

2,738,960

Beneficiaries

681,080

Avg Cost/Unit

$0.17

Spending Trend

$50.9M(2019)→$44.5M(2020)→$36.1M(2021)→$34.0M(2022)→$38.3M(2023)

YoY Change:+22.6%

5yr CAGR:+0.0%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

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

1 letter from Drugs@FDA

Date	Submission	Document
Jun 28, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 10MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Dec 17, 2001

No patent or exclusivity listings for this strength.

#002 — 20MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 17, 2001

#003 — 40MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 17, 2001