Fenofibrate - Generic Drug Details

What are the generic drug sources for fenofibrate and what is the scope of freedom to operate?

Fenofibrate is the generic ingredient in nine branded drugs marketed by Lupin, Sun Pharm Inds Ltd, Ajanta Pharma Ltd, Alembic Pharms Ltd, Ani Pharms, Apotex, Aurobindo Pharma Ltd, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Impax Labs, Invagen Pharms, Mylan Pharms Inc, Novast Labs, Reyoung, Rhodes Pharms, Rising, Torrent, Abbvie, Cipher Pharms Inc, Alembic Labs, Amneal, Aurobindo Pharma, Austarpharma, Cipla, Dr Reddys, Graviti Pharms, Hetero Labs Ltd Iii, Lupin Ltd, Mankind Pharma, Mylan, Prinston Inc, Sun Pharm, Valeant Pharms North, Salix, Abbvie Inc, and Skyepharma Ag, and is included in fifty NDAs. There are eight patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Fenofibrate has one hundred and ninety-five patent family members in thirty countries.

There are forty-two drug master file entries for fenofibrate. Fifty-one suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for fenofibrate

International Patents:	195
US Patents:	8
Tradenames:	9
Applicants:	36
NDAs:	50
Drug Master File Entries:	42
Finished Product Suppliers / Packagers:	51
Raw Ingredient (Bulk) Api Vendors:	135
Clinical Trials:	173
Patent Applications:	6,916
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for fenofibrate
Drug Sales Revenues:	Drug sales revenues for fenofibrate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for fenofibrate
What excipients (inactive ingredients) are in fenofibrate?	fenofibrate excipients list
DailyMed Link:	fenofibrate at DailyMed

See drug prices for fenofibrate

See drug sales revenues for fenofibrate

Recent Clinical Trials for fenofibrate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 4
University of Colorado, Denver	Phase 4
Mario Luca Morieri	N/A

See all fenofibrate clinical trials

Generic filers with tentative approvals for FENOFIBRATE

Applicant	Application No.	Strength	Dosage Form
		130MG	CAPSULE; ORAL
		43MG	CAPSULE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for fenofibrate

Drug Class

Peroxisome Proliferator Receptor alpha Agonist

Medical Subject Heading (MeSH) Categories for fenofibrate

Hypolipidemic Agents

Paragraph IV (Patent) Challenges for FENOFIBRATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FENOGLIDE	Tablets	fenofibrate	40 mg and 120 mg	022118	1	2010-03-17
ANTARA (MICRONIZED)	Capsules	fenofibrate	43 mg and 130 mg	021695	1	2008-09-15
TRICOR	Tablets	fenofibrate	48 mg	021656	1	2008-07-01
TRICOR	Tablets	fenofibrate	145 mg	021656	1	2007-10-19

US Patents and Regulatory Information for fenofibrate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dr Reddys Labs Sa	FENOFIBRATE (MICRONIZED)	fenofibrate	CAPSULE;ORAL	090859-002	Mar 1, 2012	AB	RX	No	No
Abbvie	TRICOR (MICRONIZED)	fenofibrate	CAPSULE;ORAL	019304-002	Feb 9, 1998		DISCN	Yes	No
Mylan	FENOFIBRATE	fenofibrate	TABLET;ORAL	076520-002	Dec 29, 2005		DISCN	No	No
Salix	FENOGLIDE	fenofibrate	TABLET;ORAL	022118-001	Aug 10, 2007	AB	RX	Yes	No			Y
Prinston Inc	FENOFIBRATE	fenofibrate	TABLET;ORAL	211080-002	Aug 28, 2018	AB	RX	No	No

Expired US Patents for fenofibrate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie Inc	TRICOR	fenofibrate	TABLET;ORAL	021203-001	Sep 4, 2001
Cipher Pharms Inc	LIPOFEN	fenofibrate	CAPSULE;ORAL	021612-003	Jan 11, 2006
Abbvie	TRICOR	fenofibrate	TABLET;ORAL	021656-001	Nov 5, 2004
Abbvie Inc	TRICOR	fenofibrate	TABLET;ORAL	021203-003	Sep 4, 2001
Cipher Pharms Inc	LIPOFEN	fenofibrate	CAPSULE;ORAL	021612-001	Jan 11, 2006

International Patents for fenofibrate

Country	Patent Number	Title	Estimated Expiration
Taiwan	200403079	Nanoparticulate fibrate formulations
China	1867321	A solid dosage form comprising a fibrate
World Intellectual Property Organization (WIPO)	2005034920
Japan	2010280685	NANOPARTICULATE COMPOSITION OF MAP KINASE INHIBITOR
Canada	2719811	FORMES GALENIQUES DE FENOFIBRATE (FENOFIBRATE DOSAGE FORMS)