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FIBRICOR

NDA

FENOFIBRIC ACID | N022418 | ROSEMONT PHARMACEUTICALS LLC

2 strengths4 unique patents0 unique exclusivities

Patent Timeline

4 unique patents by expiration date

Active (4)Today

2027

Today

Aug. 20, 2027

Aug. 20, 2027

Aug. 20, 2027

Aug. 20, 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

API Supply Chain4 active DMFs

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

OLON SPAFENOFIBRIC ACID

DMF 199952006

ALEMBIC PHARMACEUTICALS LTDFENOFIBRIC ACID CHOLINE SALT USP (CHOLINE FENOFIBRATE)

DMF 230472009

HARMAN FINOCHEM LTDFENOFIBRIC ACID

DMF 238552010

ALEMBIC PHARMACEUTICALS LTDFENOFIBRIC ACID

DMF 242772010

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 -20	View Letter (PDF)
Jun 7, 2021	SUPPL -19	View Letter (PDF)
Oct 1, 2019	SUPPL -16	View Letter (PDF)
May 24, 2018	SUPPL -14	View Letter (PDF)
Jan 7, 2014	SUPPL -11	View Letter (PDF)
Mar 19, 2013	SUPPL -10	View Letter (PDF)
Dec 19, 2012	SUPPL -9	View Letter (PDF)
Dec 19, 2012	SUPPL -8	View Letter (PDF)
Mar 19, 2012	SUPPL -7	View Letter (PDF)
Jan 17, 2012	SUPPL -6	View Letter (PDF)
Aug 21, 2009	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 35MG

RLD

4 patents0 exclusivities▴

TABLET;ORAL | Approved: Aug 14, 2009

Patents (4)

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
7569612	Aug 20, 2027	—	—	—	—
7741373	Aug 20, 2027	—	—	—	—
7741374	Aug 20, 2027	—	—	—	—
7915247	Aug 20, 2027	—	—	—	—

#002 — 105MG

RLD

4 patents0 exclusivities▾

TABLET;ORAL | Approved: Aug 14, 2009