Viewing data from:

LIPOFEN

NDA

FENOFIBRATE | N021612 | CIPHER PHARMACEUTICALS 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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Lipofen (2023)

Total Spending

$205K

Total Claims

363

Beneficiaries

Avg Cost/Unit

$9.05

Spending Trend

$34K(2021)→$224K(2022)→$205K(2023)

YoY Change:+12.8%

5yr CAGR:+10.4%

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

API Supply Chain15 active DMFs16 inactive

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

VANAMALI ORGANICS PVT LTDFENOFIBRATE

DMF 111941994

CORDEN PHARMA CHENOVEFENOFIBRATE

DMF 120781996

OLON SPAFENOFIBRATE

DMF 138011998

OLON SPAFENOFIBRATE

DMF 154382001

ALEMBIC PHARMACEUTICALS LTDFENOFIBRATE USP

DMF 162082002

CORDEN PHARMA CHENOVEFENOFIBRATE INTERMEDIATE DRUG SUBSTANCE

DMF 207252007

LUPIN LTDFENOFIBRATE USP

DMF 215512008

HARMAN FINOCHEM LTDFENOFIBRATE USP

DMF 232812009

TEVA PHARMACEUTICAL INDUSTRIES LTDFENOFIBRATE CHOLINE

DMF 235402010

DERIVADOS QUIMICOS SAUFENOFIBRATE

DMF 240322010

UNICHEM LABORATORIES LTDFENOFIBRATE USP

DMF 243932010

JIANGSU NHWA PHARMACEUTICAL CO LTDFENOFIBRATE

DMF 244532010

ZHEJIANG YONGTAI PHARMACEUTICAL CO LTDFENOFIBRATE USP

DMF 289992015

IOL CHEMICALS AND PHARMACEUTICALS LTDFENOFIBRATE USP

DMF 365352022

SURAJ LABORATORIES PRIVATE LTDFENOFIBRATE USP

DMF 409382024

EPROVA AGInactiveFENOFIBRATE (PROCETOFEN)

DMF 64561986

LABORATOIRES FOURNIER SAInactiveFENOFIBRATE CAPSULES

DMF 69521987

PLAISTOW LTDInactiveFENOFIBRATE

DMF 72741987

CHEMICAL PHARMACEUTICAL RESEARCH INSTITUTE NIHFI LTDInactiveFENOFIBRATE

DMF 106741993

ORGAPHARMInactiveFENOFIBRATE DRUG SUBSTANCE

DMF 141571999

COPRIMA SAInactiveFENOFIBRATE

DMF 154692001

PCASInactiveFENOFIBRATE

DMF 160652002

ABBOTT LABORATORIESInactiveFENOFIBRATE SPRAY GRANULATION INTERMEDIATE

DMF 168982003

ANONIMA MATERIE SINTETICHE AND AFFINI (AMSA) SPAInactiveFENOFIBRATE

DMF 169712003

LABORATOIRES FOURNIER SAInactiveFENOFIBRATE SPRAY GRANULATION INTERMEDIATE

DMF 190182005

IPCA LABORATORIES LTDInactiveFENOFIBRATE USP

DMF 216772008

MOEHS IBERICA SLInactiveFENOFIBRATE

DMF 232502009

SMRUTHI ORGANICS LTDInactiveFENOFIBRATE USP

DMF 239402010

DK PHARMA CHEM PVT LTDInactiveFENOFIBRATE USP

DMF 250342011

FINORGA SASInactiveFENOFIBRATE

DMF 254742011

D K PHARMACHEM PVT LTDInactiveFENOFIBRATE USP (PROCESS B)

DMF 279772014

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

Approval Letters

11 letters from Drugs@FDA

Date	Submission	Document
Jun 9, 2025	SUPPL -26	View Letter (PDF)
Jun 7, 2021	SUPPL -24	View Letter (PDF)
May 16, 2019	SUPPL -20	View Letter (PDF)
Nov 15, 2018	SUPPL -17	View Letter (PDF)
May 21, 2018	SUPPL -18	View Letter (PDF)
Jan 23, 2013	SUPPL -14	View Letter (PDF)
Jan 23, 2013	SUPPL -15	View Letter (PDF)
Nov 2, 2011	SUPPL -7	View Letter (PDF)
Dec 19, 2008	SUPPL -4	View Letter (PDF)
Dec 19, 2008	SUPPL -2	View Letter (PDF)
Jan 24, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 50MG

RLD

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Jan 11, 2006

No patent or exclusivity listings for this strength.

#002 — 100MG

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Jan 11, 2006

#003 — 150MG

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Jan 11, 2006