Viewing data from:

FLOLIPID

NDA

SIMVASTATIN | N206679 | SALERNO PHARMACEUTICALS

2 strengths2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Expiring < 1yr (1)Active (1)Today

2027

2028

2029

2030

Today

9597289

Feb. 23, 2030

10300041

Apr. 26, 2027

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 Flolipid (2023)

Total Spending

$5K

Total Claims

Beneficiaries

—

Avg Cost/Unit

$1.85

Spending Trend

$8K(2019)→$8K(2022)→$5K(2023)

YoY Change:+1.1%

5yr CAGR:+1.5%

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

API Supply Chain14 active DMFs27 inactive

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

TEVA PHARMACEUTICAL INDUSTRIES LTDSIMVASTATIN

DMF 145991999

ZHEJIANG HISUN PHARMACEUTICAL CO LTDSIMVASTATIN USP

DMF 163052002

LUPIN LTDSIMVASTATIN USP

DMF 179342004

BIOCON LTDSIMVASTATIN

DMF 184492005

JUBILANT PHARMOVA LTDSIMVASTATIN USP

DMF 187552005

SOUTHWEST SYNTHETIC PHARMACEUTICAL CORP LTDSIMVASTATIN USP

DMF 234252009

TEVA PHARMACEUTICAL INDUSTRIES LTDSIMVASTATIN (ETHANOL PROCESS)

DMF 250242011

ZHEJIANG JIANGBEI PHARMACEUTICAL CO LTDSIMVASTATIN

DMF 269712013

HENAN TOPFOND PHARMACEUTICAL CO LTDSIMVASTATIN AMMONIUM SALT(DRUG SUBSTANCE INTERMEDIATE)

DMF 278822014

ZHEJIANG JIANGBEI PHARMACEUTICAL CO LTDSIMVASTATIN (WITH 0.01% BHA)

DMF 285832014

HENAN TOPFOND SCI-TECH CO LTDSIMVASTATIN AMMONIUM SALT (DRUG SUBSTANCE INTERMEDIATE)

DMF 327862018

HENAN TOPFOND SCI-TECH CO LTDSIMVASTATIN (DRUG SUBSTANCE)

DMF 340892019

THEMIS MEDICARE LTD DBA ARTEMIS BIOTECHSIMVASTATIN AMMONIUM SALT

DMF 398672024

ZHEJIANG JIANGBEI NANHAI PHARMACEUTICAL CO LTDSIMVASTATIN

DMF 403842024

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveSIMVASTATIN USP

DMF 157222001

BIOCON LTDInactiveSIMVASTATIN USP

DMF 160942002

KREBS BIOCHEMICALS INDUSTRIES LTDInactiveSIMVASTATIN USP

DMF 171512004

LEK PHARMACEUTICALS DDInactiveSIMVASTATIN

DMF 175682004

APITORIA PHARMA PRIVATE LTDInactiveSIMVASTATIN USP

DMF 178292004

GLENMARK PHARMACEUTICALS LTDInactiveSIMVASTATIN

DMF 179592004

ZHEJIANG RUIBANG LABORATORIES INCInactiveSIMVASTATIN USP

DMF 181012005

CADILA HEALTHCARE LTDInactiveSIMVASTATIN

DMF 182232005

ZHEJIANG APELOA PHARMACEUTICAL CO LTDInactiveSIMVASTATIN USP BULK

DMF 183092005

SYNTHON BVInactiveSIMVASTATIN

DMF 183842005

ARTEMIS BIOTECHInactiveSIMVASTATIN USP

DMF 185222005

CONCORD BIOTECH LTDInactiveSIMVASTATIN USP

DMF 190442005

KREBS BIOCHEMICALS INDUSTRIES LTDInactiveSIMVASTATIN AMMONIUM SALT (INTERMEDIATE)

DMF 195362006

CADILA HEALTHCARE LTDInactiveSIMVASTATIN ( LOVASTATIN ROUTE)

DMF 201252007

CADILA HEALTHCARE LTDInactiveSIMVASTATIN (AMMONIUM SALT ROUTE)

DMF 203732007

MYLAN LABORATORIES LTDInactiveSIMVASTATIN USP

DMF 209032007

DR REDDYS LABORATORIES LTDInactiveSIMVASTATIN USP

DMF 212652008

SANDOZ INDUSTRIAL PRODUCTS SPAInactiveSIMVASTATIN

DMF 222832008

HETERO LABS LTDInactiveSIMVASTATIN

DMF 230122009

ZHEJIANG JIANGBEI PHARMACEUTICAL CO LTDInactiveSIMVASTATIN AMMONIUM SALT

DMF 249352011

SOUTHWEST SYNTHETIC PHARMACEUTICAL CO LTDInactiveSIMVASTATIN AMMONIUM SALT

DMF 249672011

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveSIMVASTATIN (BHA ADDED) USP

DMF 260482012

ZHEJIANG JIANGBEI PHARMACEUTICAL CO LTDInactiveSIMVASTATIN AMMONIUM SALT (ALTERNATIVE PROCESS)

DMF 260882012

HEC PHARM USA INCInactiveSIMVASTATIN NON-STERILE DRUG SUBSTANCE, BULK FORM

DMF 268432013

HEC PHARM CO LTDInactiveSIMVASTATIN NON-STERILE BULK DRUG SUBSTANCE

DMF 274382013

STERLING BIOTECH LTDInactiveSIMVASTATIN AMMONIUM SALT (INTERMEDIATE)

DMF 308362016

STERLING BIOTECH LTDInactiveSIMVASTATIN USP

DMF 308372016

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Sep 28, 2020	SUPPL -3	View Letter (PDF)
Oct 6, 2017	SUPPL -2	View Letter (PDF)
Apr 28, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 20MG/5ML

RLD

2 patents0 exclusivities▴

SUSPENSION;ORAL | Approved: Apr 21, 2016

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9597289	Feb 23, 2030	—	—	Yes	—	—
10300041	Apr 26, 2027	—	—	Yes	—	—

#002 — 40MG/5ML

RLD

2 patents0 exclusivities▾

SUSPENSION;ORAL | Approved: Apr 21, 2016