Viewing data from:

ALTOPREV

NDA

LOVASTATIN | N021316 | AZURITY PHARMACEUTICALS SWITZERLAND GMBH

4 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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Altoprev (2023)

Total Spending

$762K

Total Claims

508

Beneficiaries

182

Avg Cost/Unit

$37.11

Spending Trend

$1.7M(2019)→$1.8M(2020)→$1.7M(2021)→$1.6M(2022)→$762K(2023)

YoY Change:+1.8%

5yr CAGR:+4.5%

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

13 letters from Drugs@FDA

Date	Submission	Document
Sep 28, 2020	SUPPL -36	View Letter (PDF)
Mar 2, 2018	SUPPL -35	View Letter (PDF)
Aug 8, 2017	SUPPL -34	View Letter (PDF)
May 1, 2014	SUPPL -31	View Letter (PDF)
Dec 27, 2012	SUPPL -28	View Letter (PDF)
Nov 5, 2012	SUPPL -29	View Letter (PDF)
May 2, 2012	SUPPL -26	View Letter (PDF)
Feb 12, 2007	SUPPL -18	View Letter (PDF)
Jul 21, 2004	SUPPL -10	View Letter (PDF)
May 28, 2004	SUPPL -1	View Letter (PDF)
Sep 30, 2003	SUPPL -6	View Letter (PDF)
Aug 28, 2003	SUPPL -5	View Letter (PDF)
Jun 26, 2002	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 10MG

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Jun 26, 2002

No patent or exclusivity listings for this strength.

#002 — 20MG

RLD

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Jun 26, 2002

#003 — 40MG

RLD

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Jun 26, 2002

#004 — 60MG

RLD

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Jun 26, 2002