FENOFIBRATE - Generic Drug Details

✉ Email this page to a colleague

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, Norvium Bioscience, Novast Labs, Reyoung, Rhodes Pharms, Rising, Torrent, Abbvie, Cipher Pharms Inc, Amneal, Aurobindo Pharma, Austarpharma, Chartwell Rx, Cipla, Creekwood Pharms, Dr Reddys, Hetero Labs Ltd Iii, Lupin Ltd, Mankind Pharma, Mylan, Mylan Pharms Inc, Prinston Inc, Sun Pharm, Valeant Pharms North, Yichang Humanwell, Salix, and Skyepharma Ag, and is included in fifty-three 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-four suppliers are listed for this compound.

Summary for FENOFIBRATE

International Patents:	31
US Patents:	6
Tradenames:	9
Applicants:	38
NDAs:	53
Drug Master File Entries:	42
Finished Product Suppliers / Packagers:	54
Raw Ingredient (Bulk) Api Vendors:	138
Clinical Trials:	182
Patent Applications:	7,206
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
Lindsay Ferguson, MD	Phase 1
Tanta University	Phase 4
Han Ying	Phase 2/Phase 3

See all FENOFIBRATE clinical trials

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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cipla	FENOFIBRATE	fenofibrate	TABLET;ORAL	208709-001	Dec 15, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Dr Reddys	FENOFIBRATE	fenofibrate	TABLET;ORAL	210670-001	Sep 6, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma	FENOFIBRATE	fenofibrate	TABLET;ORAL	216798-002	Sep 27, 2022	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

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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
Salix	FENOGLIDE	fenofibrate	TABLET;ORAL	022118-001	Aug 10, 2007	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for FENOFIBRATE

Subscribe to access the full database, or Sign Up
Country	Patent Number	Title	Estimated Expiration
China	1874758	Compositions comprising fenofibrate and pravastatin	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2005034908		⤷ Sign Up
Russian Federation	2343905	ТВЕРДЫЕ ДОЗИРОВАННЫЕ ФОРМЫ, ВКЛЮЧАЮЩИЕ ФИБРАТ И СТАТИН (SOLID DOSED OUT FORMS INCLUDING FIBRAT AND STATIN)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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

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.