➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Last Updated: October 23, 2021

DrugPatentWatch Database Preview

Fenofibrate - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing

« Back to Dashboard

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, Austarpharma, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Impax Labs, Invagen Pharms, Mylan Pharms Inc, Novast Labs, Rhodes Pharms, Torrent, Abbvie, Cipher Pharms Inc, Adaptis, Alembic Labs, Amneal, Aurobindo Pharma Ltd, 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 forty-eight NDAs. There are nine patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

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

Summary for fenofibrate

International Patents:	235
US Patents:	9
Tradenames:	9
Applicants:	34
NDAs:	48
Drug Master File Entries:	42
Finished Product Suppliers / Packagers:	53
Raw Ingredient (Bulk) Api Vendors:	128
Clinical Trials:	160
Patent Applications:	6,945
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
University of Minnesota	Phase 2
Alessandro Doria	Phase 2
University of Michigan	Phase 2

See all fenofibrate clinical trials

Generic filers with tentative approvals for FENOFIBRATE

Applicant	Application No.	Strength	Dosage Form
⤷ Try it Free	⤷ Try it Free	130MG	CAPSULE; ORAL
⤷ Try it Free	⤷ Try it Free	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	NDA	Submissiondate
FENOGLIDE	TABLET;ORAL	fenofibrate	022118	2010-03-17
ANTARA (MICRONIZED)	CAPSULE;ORAL	fenofibrate	021695	2008-09-15
TRICOR	TABLET;ORAL	fenofibrate	021656	2008-07-01
TRICOR	TABLET;ORAL	fenofibrate	021656	2007-10-19
TRICOR	TABLET;ORAL	fenofibrate	021203
LIPIDIL	CAPSULE;ORAL	fenofibrate	019304
TRICOR (MICRONIZED)	CAPSULE;ORAL	fenofibrate	019304

US Patents and Regulatory Information for fenofibrate

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Try it Free
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Invagen Pharms	FENOFIBRATE (MICRONIZED)	fenofibrate	CAPSULE;ORAL	207378-003	Mar 28, 2017	AB	RX	No	No	⤷ Try it Free	⤷ Try it Free				⤷ Try it Free
Apotex	FENOFIBRATE (MICRONIZED)	fenofibrate	CAPSULE;ORAL	202252-002	Jul 26, 2013	AB	RX	No	No	⤷ Try it Free	⤷ Try it Free				⤷ Try it Free
Lupin Ltd	FENOFIBRATE	fenofibrate	TABLET;ORAL	204019-001	Aug 17, 2015	AB	RX	No	No	⤷ Try it Free	⤷ Try it Free				⤷ Try it Free
Austarpharma	FENOFIBRATE (MICRONIZED)	fenofibrate	CAPSULE;ORAL	207805-003	Nov 16, 2017	AB	RX	No	No	⤷ Try it Free	⤷ Try it Free				⤷ Try it Free
>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

Subscribe to access the full database, or Try it Free
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	TRICOR	fenofibrate	TABLET;ORAL	021656-002	Nov 5, 2004	⤷ Try it Free	⤷ Try it Free
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-002	Nov 30, 2004	⤷ Try it Free	⤷ Try it Free
Abbvie	TRICOR	fenofibrate	TABLET;ORAL	021656-002	Nov 5, 2004	⤷ Try it Free	⤷ Try it Free
Abbvie	TRICOR	fenofibrate	TABLET;ORAL	021656-001	Nov 5, 2004	⤷ Try it Free	⤷ Try it Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for fenofibrate

Subscribe to access the full database, or Try it Free
Country	Patent Number	Estimated Expiration
European Patent Office	1519715	⤷ Try it Free
Japan	2004509146	⤷ Try it Free
Portugal	1318788	⤷ Try it Free
European Patent Office	1117384	⤷ Try it Free
>Country	>Patent Number	>Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

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.