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Last Updated: November 29, 2023

Fenofibrate - Generic Drug Details

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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, 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, Amneal, Aurobindo Pharma, Austarpharma, Chartwell Rx, Cipla, Creekwood Pharms, Dr Reddys, Graviti Pharms, Hetero Labs Ltd Iii, Lupin Ltd, Mankind Pharma, Mylan, Prinston Inc, Sun Pharm, Valeant Pharms North, Salix, and Skyepharma Ag, and is included in fifty-one 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-two 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:	51
Drug Master File Entries:	42
Finished Product Suppliers / Packagers:	52
Raw Ingredient (Bulk) Api Vendors:	138
Clinical Trials:	179
Patent Applications:	6,855
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

Drug Sales Revenue Trends for fenofibrate

See drug sales revenues for fenofibrate

Recent Clinical Trials for fenofibrate

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

Sponsor	Phase
Tanta University	Phase 2
Eman Ibrahim Elberri, Faculty of Pharmacy, Tanta University	Phase 2
Manal Ali Mahrous Hamouda Faculty of Pharmacy, Menufia University	Phase 2

See all fenofibrate clinical trials

Generic filers with tentative approvals for FENOFIBRATE

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	130MG	CAPSULE; ORAL
⤷ Try a Trial	⤷ Try a Trial	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

Anatomical Therapeutic Chemical (ATC) Classes for fenofibrate

C10AB	Fibrates
C10A	LIPID MODIFYING AGENTS, PLAIN
C10	LIPID MODIFYING AGENTS
C	Cardiovascular system

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Salix	FENOGLIDE	fenofibrate	TABLET;ORAL	022118-001	Aug 10, 2007	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Prinston Inc	FENOFIBRATE	fenofibrate	TABLET;ORAL	211080-001	Aug 28, 2018	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mylan Pharms Inc	FENOFIBRATE	fenofibrate	TABLET;ORAL	204475-001	Jun 23, 2016	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Lupin Ltd	FENOFIBRATE	fenofibrate	TABLET;ORAL	204019-001	Aug 17, 2015	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sun Pharm Inds Ltd	FENOFIBRATE	fenofibrate	TABLET;ORAL	076635-003	Oct 31, 2005	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Creekwood Pharms	FENOFIBRATE	fenofibrate	TABLET;ORAL	217732-001	Sep 7, 2023	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Rhodes Pharms	FENOFIBRATE (MICRONIZED)	fenofibrate	CAPSULE;ORAL	075753-002	Apr 9, 2002	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for fenofibrate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	TRICOR	fenofibrate	TABLET;ORAL	021656-002	Nov 5, 2004	⤷ Try a Trial	⤷ Try a Trial
Abbvie	TRICOR	fenofibrate	TABLET;ORAL	021203-001	Sep 4, 2001	⤷ Try a Trial	⤷ Try a Trial
Cipher Pharms Inc	LIPOFEN	fenofibrate	CAPSULE;ORAL	021612-001	Jan 11, 2006	⤷ Try a Trial	⤷ Try a Trial
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-003	Nov 30, 2004	⤷ Try a Trial	⤷ Try a Trial
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-003	Nov 30, 2004	⤷ Try a Trial	⤷ Try a Trial
Abbvie	TRICOR	fenofibrate	TABLET;ORAL	021656-002	Nov 5, 2004	⤷ Try a Trial	⤷ Try a Trial
Abbvie	TRICOR	fenofibrate	TABLET;ORAL	021203-003	Sep 4, 2001	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for fenofibrate

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Country	Patent Number	Title	Estimated Expiration
Spain	2343405		⤷ Try a Trial
European Patent Office	1551457	COMPOSITIONS POUR DOSES LIQUIDES D'AGENTS ACTIFS NANOPARTICULAIRES STABLES (LIQUID DOSAGE COMPOSITIONS OF STABLE NANOPARTICULATE ACTIVE AGENTS)	⤷ Try a Trial
Japan	2010018604	BIOADHESIVE NANOPARTICLE COMPOSITION HAVING CATIONIC SURFACE STABILIZER	⤷ Try a Trial
Japan	4611641		⤷ Try a Trial
South Korea	20060085682	A SOLID DOSAGE FORM COMPRISING A FIBRATE AND A STATIN	⤷ Try a Trial
Spain	2298270		⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2006037347		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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