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, 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-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:	38
NDAs:	53
Drug Master File Entries:	42
Finished Product Suppliers / Packagers:	51
Raw Ingredient (Bulk) Api Vendors:	138
Clinical Trials:	182
Patent Applications:	6,868
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
Lindsay Ferguson, MD	Phase 1
Tanta University	Phase 4
Han Ying	Phase 2/Phase 3

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

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
Rhodes Pharms	FENOFIBRATE	fenofibrate	TABLET;ORAL	076433-002	May 13, 2005	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Torrent	FENOFIBRATE (MICRONIZED)	fenofibrate	CAPSULE;ORAL	210782-003	Jun 26, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Salix	FENOGLIDE	fenofibrate	TABLET;ORAL	022118-002	Aug 10, 2007	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Prinston Inc	FENOFIBRATE	fenofibrate	TABLET;ORAL	211080-002	Aug 28, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma	FENOFIBRATE	fenofibrate	TABLET;ORAL	205118-002	May 5, 2016	AB	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Austarpharma	FENOFIBRATE	fenofibrate	TABLET;ORAL	207803-002	Dec 19, 2017	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	021203-001	Sep 4, 2001	⤷ Sign Up	⤷ Sign Up
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-003	Nov 30, 2004	⤷ Sign Up	⤷ Sign Up
Abbvie	TRICOR	fenofibrate	TABLET;ORAL	021656-002	Nov 5, 2004	⤷ Sign Up	⤷ Sign Up
Skyepharma Ag	TRIGLIDE	fenofibrate	TABLET;ORAL	021350-002	May 7, 2005	⤷ Sign Up	⤷ Sign Up
Abbvie	TRICOR	fenofibrate	TABLET;ORAL	021656-002	Nov 5, 2004	⤷ 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
World Intellectual Property Organization (WIPO)	2006037347		⤷ Sign Up
Japan	5069001		⤷ Sign Up
Russian Federation	2006115596	ТВЕРДЫЕ ДОЗИРОВАННЫЕ ФОРМЫ, ВКЛЮЧАЮЩИЕ ФИБРАТ И СТАТИН	⤷ Sign Up
European Patent Office	1804768	COMPOSITIONS PHARMACEUTIQUES CONTENANT DU FENOFIBRATE ET DE L'ATORVASTATINE (PHARMACEUTICAL COMPOSITIONS COMPRISING FENOFIBRATE AND ATORVASTATIN)	⤷ Sign Up
Japan	2007508249		⤷ Sign Up
Australia	2009201881	A solid dosage form comprising a fibrate and a statin	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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