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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 Atlantis, Sun Pharm Inds Ltd, Ajanta Pharma Ltd, Ani Pharms Inc, 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, Alembic Pharms Ltd, Amneal, Aurobindo Pharma Ltd, Cipla, Dr Reddys, Graviti Pharms, Hetero Labs Ltd Iii, Lupin Ltd, Mankind Pharma, Mylan, Orit Labs Llc, Prinston Inc, Sun Pharm, Valeant Pharms North, Salix, Abbvie Inc, and Skyepharma Ag, and is included in forty-six NDAs. There are twelve patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Fenofibrate has three hundred and twenty-nine patent family members in forty-six countries.

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

Summary for fenofibrate

International Patents:	329
US Patents:	12
Tradenames:	9
Applicants:	33
NDAs:	46
Drug Master File Entries:	42
Suppliers / Packagers:	56
Bulk Api Vendors:	119
Clinical Trials:	153
Patent Applications:	4,656
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
DailyMed Link:	fenofibrate at DailyMed

See drug prices for fenofibrate

See drug sales revenues for fenofibrate

Recent Clinical Trials for fenofibrate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Rehab Werida	Phase 4
Singapore General Hospital	Phase 3
National Medical Research Council (NMRC), Singapore	Phase 3

See all fenofibrate clinical trials

Generic filers with tentative approvals for FENOFIBRATE

Applicant	Application No.	Strength	Dosage Form
		130MG	CAPSULE; ORAL
		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 (MICRONIZED)	CAPSULE;ORAL	fenofibrate	019304
TRICOR	TABLET;ORAL	fenofibrate	021203
LIPIDIL	CAPSULE;ORAL	fenofibrate	019304

US Patents and Regulatory Information for fenofibrate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ajanta Pharma Ltd	FENOFIBRATE	fenofibrate	TABLET;ORAL	210138-001	Jul 23, 2018	AB	RX	No	No
Lupin Atlantis	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-005	Oct 18, 2013		RX	Yes	No
Mankind Pharma	FENOFIBRATE	fenofibrate	TABLET;ORAL	213864-001	Jun 12, 2020	AB	RX	No	No

Expired US Patents for fenofibrate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	TRICOR	fenofibrate	TABLET;ORAL	021656-001	Nov 5, 2004
Abbvie	TRICOR	fenofibrate	TABLET;ORAL	021656-001	Nov 5, 2004
Abbvie	TRICOR	fenofibrate	TABLET;ORAL	021656-002	Nov 5, 2004

International Patents for fenofibrate

Country	Patent Number	Estimated Expiration
Japan	5641682
Japan	2004509146
China	101797245