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Last Updated: June 2, 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
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
⤷ Sign Up	⤷ Sign Up	130MG	CAPSULE; ORAL
⤷ Sign Up	⤷ Sign Up	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

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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
Dr Reddys Labs Sa	FENOFIBRATE (MICRONIZED)	fenofibrate	CAPSULE;ORAL	090859-002	Mar 1, 2012	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Impax Labs	FENOFIBRATE (MICRONIZED)	fenofibrate	CAPSULE;ORAL	075868-002	Oct 27, 2003		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan Pharms Inc	FENOFIBRATE (MICRONIZED)	fenofibrate	CAPSULE;ORAL	202579-002	Jan 10, 2013		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Valeant Pharms North	FENOFIBRATE	fenofibrate	TABLET;ORAL	090715-002	Apr 5, 2012	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm Inds Ltd	FENOFIBRATE	fenofibrate	CAPSULE;ORAL	201748-002	Oct 31, 2014	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ajanta Pharma Ltd	FENOFIBRATE (MICRONIZED)	fenofibrate	CAPSULE;ORAL	210705-001	Sep 10, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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	021203-003	Sep 4, 2001	⤷ Sign Up	⤷ Sign Up
Abbvie	TRICOR	fenofibrate	TABLET;ORAL	021656-002	Nov 5, 2004	⤷ Sign Up	⤷ Sign Up
Abbvie	TRICOR	fenofibrate	TABLET;ORAL	021203-003	Sep 4, 2001	⤷ Sign Up	⤷ Sign Up
Abbvie	TRICOR	fenofibrate	TABLET;ORAL	021203-001	Sep 4, 2001	⤷ Sign Up	⤷ Sign Up
Abbvie	TRICOR	fenofibrate	TABLET;ORAL	021203-001	Sep 4, 2001	⤷ Sign Up	⤷ Sign Up
Abbvie	TRICOR	fenofibrate	TABLET;ORAL	021656-001	Nov 5, 2004	⤷ Sign Up	⤷ Sign Up
>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
China	1874758	Compositions comprising fenofibrate and pravastatin	⤷ Sign Up
European Patent Office	1680086	FORME POSOLOGIQUE SOLIDE COMPRENANT UNE FIBRATE ET UNE STATINE (A SOLID DOSAGE FORM COMPRISING A FIBRATE AND A STATIN)	⤷ Sign Up
Japan	2007508248		⤷ Sign Up
Switzerland	707330	Composizioni farmaceutiche a dose ridotta di fenofibrato.	⤷ Sign Up
European Patent Office	1818049	Atorvastatin stabilisée (Stabilized Atorvastatin)	⤷ Sign Up
Canada	2540984	FORME DE DOSE SOLIDE COMPRENANT UN FIBRATE (A SOLID DOSAGE FORM COMPRISING A FIBRATE)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.