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 Pharms Ltd, Ani Pharms, Apotex, Aurobindo Pharma Ltd, 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, Adaptis, Alembic Labs, Amneal, Austarpharma, 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-nine NDAs. There are eight patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

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

Summary for FENOFIBRATE

International Patents:	195
US Patents:	8
Tradenames:	9
Applicants:	36
NDAs:	49
Drug Master File Entries:	42
Finished Product Suppliers / Packagers:	52
Raw Ingredient (Bulk) Api Vendors:	129
Clinical Trials:	170
Patent Applications:	7,515
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
Seoul National University Bundang Hospital	Phase 4
University of Minnesota	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
See Plans and Pricing	See Plans and Pricing	130MG	CAPSULE; ORAL
See Plans and Pricing	See Plans and Pricing	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
Mylan	FENOFIBRATE	fenofibrate	TABLET;ORAL	076520-003	Oct 25, 2007	AB	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Dr Reddys	FENOFIBRATE	fenofibrate	TABLET;ORAL	210670-001	Sep 6, 2019	AB	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Graviti Pharms	FENOFIBRATE	fenofibrate	TABLET;ORAL	211122-002	Mar 18, 2020	AB	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Invagen Pharms	FENOFIBRATE (MICRONIZED)	fenofibrate	CAPSULE;ORAL	207378-001	Mar 28, 2017	AB	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
>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 (MICRONIZED)	fenofibrate	CAPSULE;ORAL	019304-003	Jun 30, 1999	See Plans and Pricing	See Plans and Pricing
Abbvie	TRICOR (MICRONIZED)	fenofibrate	CAPSULE;ORAL	019304-004	Jun 30, 1999	See Plans and Pricing	See Plans and Pricing
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-002	Nov 30, 2004	See Plans and Pricing	See Plans and Pricing
Abbvie Inc	TRICOR	fenofibrate	TABLET;ORAL	021203-003	Sep 4, 2001	See Plans and Pricing	See Plans and Pricing
>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
Argentina	072134	COMPOSICIONES DE NANOPARTICULAS DE INHIBIDORES DE ANGIOGENESIS	See Plans and Pricing
Japan	4842514		See Plans and Pricing
European Patent Office	1471887	COMPOSITIONS NANOPARTICULAIRES A STABILISATEUR SUPERFICIEL DE LYSOZYME (NANOPARTICULATE COMPOSITIONS HAVING LYSOZYME AS A SURFACE STABILIZER)	See Plans and Pricing
Denmark	2263652		See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration

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