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Last Updated: May 20, 2024

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, Chartwell, 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-two NDAs. There are six patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Fenofibrate has thirty-one patent family members in twelve 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:	31
US Patents:	6
Tradenames:	9
Applicants:	37
NDAs:	52
Drug Master File Entries:	42
Finished Product Suppliers / Packagers:	51
Raw Ingredient (Bulk) Api Vendors:	138
Clinical Trials:	179
Patent Applications:	6,968
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
Manal Ali Mahrous Hamouda Faculty of Pharmacy, Menufia University	Phase 2
Fedaa Abd El-monem Kamal El-deen Kotkata Faculty of Pharmacy, Tanta University	Phase 2
Tanta 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
Sun Pharm Inds Ltd	FENOFIBRATE	fenofibrate	TABLET;ORAL	076635-002	Oct 31, 2005		RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Austarpharma	FENOFIBRATE	fenofibrate	TABLET;ORAL	208476-002	Feb 10, 2021	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Dr Reddys Labs Sa	FENOFIBRATE (MICRONIZED)	fenofibrate	CAPSULE;ORAL	090859-002	Mar 1, 2012	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
Chartwell	FENOFIBRATE (MICRONIZED)	fenofibrate	CAPSULE;ORAL	211407-002	Jan 31, 2024	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Rising	FENOFIBRATE (MICRONIZED)	fenofibrate	CAPSULE;ORAL	202676-003	Oct 23, 2012		DISCN	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	021656-001	Nov 5, 2004	⤷ Try a Trial	⤷ Try a Trial
Skyepharma Ag	TRIGLIDE	fenofibrate	TABLET;ORAL	021350-001	May 7, 2005	⤷ 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	021695-001	Nov 30, 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
Russian Federation	2006115596	ТВЕРДЫЕ ДОЗИРОВАННЫЕ ФОРМЫ, ВКЛЮЧАЮЩИЕ ФИБРАТ И СТАТИН	⤷ Try a Trial
Brazil	PI0415121	material particulado, forma de dosagem sólida, método para fabricar a mesma, e, uso de um material particulado ou de uma forma de dosagem sólida	⤷ Try a Trial
Japan	2007508248		⤷ Try a Trial
Australia	2004279661	A solid dosage form comprising a fibrate and a statin	⤷ Try a Trial
Canada	2540984	FORME DE DOSE SOLIDE COMPRENANT UN FIBRATE (A SOLID DOSAGE FORM COMPRISING A FIBRATE)	⤷ Try a Trial
Mexico	PA06003813	FORMA SOLIDA DE DOSIFICACION QUE COMPRENDE UN FIBRATO Y UNA ESTATINA. (A SOLID DOSAGE FORM COMPRISING A FIBRATE AND A STATIN.)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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