FENOFIBRATE - Generic Drug Details

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-three 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:	53
Raw Ingredient (Bulk) Api Vendors:	138
Clinical Trials:	182
Patent Applications:	7,283
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

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Salix	FENOGLIDE	fenofibrate	TABLET;ORAL	022118-001	Aug 10, 2007		DISCN	Yes	No			Y
Alembic	FENOFIBRATE (MICRONIZED)	fenofibrate	CAPSULE;ORAL	213842-001	Oct 19, 2020	AB	RX	No	No
Mylan	FENOFIBRATE	fenofibrate	TABLET;ORAL	076520-003	Oct 25, 2007	AB	RX	No	No
Hetero Labs Ltd Iii	FENOFIBRATE	fenofibrate	TABLET;ORAL	204598-002	Jul 12, 2016	AB	RX	No	No
Amneal	FENOFIBRATE	fenofibrate	TABLET;ORAL	209950-001	Mar 19, 2018	AB	RX	No	No

Expired US Patents for FENOFIBRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Skyepharma Ag	TRIGLIDE	fenofibrate	TABLET;ORAL	021350-001	May 7, 2005
Abbvie	TRICOR	fenofibrate	TABLET;ORAL	021656-001	Nov 5, 2004
Cipher Pharms Inc	LIPOFEN	fenofibrate	CAPSULE;ORAL	021612-001	Jan 11, 2006
Salix	FENOGLIDE	fenofibrate	TABLET;ORAL	022118-001	Aug 10, 2007
Salix	FENOGLIDE	fenofibrate	TABLET;ORAL	022118-002	Aug 10, 2007

International Patents for FENOFIBRATE

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1804768	COMPOSITIONS PHARMACEUTIQUES CONTENANT DU FENOFIBRATE ET DE L'ATORVASTATINE (PHARMACEUTICAL COMPOSITIONS COMPRISING FENOFIBRATE AND ATORVASTATIN)
Canada	2540984	FORME DE DOSE SOLIDE COMPRENANT UN FIBRATE (A SOLID DOSAGE FORM COMPRISING A FIBRATE)
Japan	2007508249
European Patent Office	1680091	FORME DE DOSE SOLIDE COMPRENANT UN FIBRATE (A SOLID DOSAGE FORM COMPRISING A FIBRATE)
Mexico	PA06003813	FORMA SOLIDA DE DOSIFICACION QUE COMPRENDE UN FIBRATO Y UNA ESTATINA. (A SOLID DOSAGE FORM COMPRISING A FIBRATE AND A STATIN.)

FENOFIBRATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Fenofibrate

Market Overview

The fenofibrate market is a significant segment within the broader fibrate drugs market, which is anticipated to experience substantial growth over the coming years. The global fibrate drugs market is projected to grow at a CAGR of 5-5.3% during the forecast period, reaching market sizes of approximately $4 billion by 2029 or $5.04 billion by 2032[1][3][4].

Drivers of Market Growth

Several factors are driving the growth of the fenofibrate market:

Increasing Prevalence of Cardiovascular Diseases

The rising incidence of cardiovascular diseases, such as heart attacks and strokes, associated with high triglyceride levels and low cholesterol, is a primary driver. The COVID-19 pandemic has further exacerbated this trend by increasing the risk of cardiovascular diseases due to physical inactivity and other lifestyle changes[4].

High Efficacy of Fenofibrate

Fenofibrate has demonstrated high efficacy in lowering triglyceride levels and improving lipid profiles, making it a preferred treatment option for hypercholesterolemia and hypertriglyceridemia. Clinical trials have shown that fenofibrate reduces plasma levels of lipoproteins by 7% to 23% and lowers serum uric acid levels[1][3].

Growing Population with Dyslipidemia

A large population, especially in regions like the Asia Pacific, is at risk due to sedentary lifestyles, smoking, drinking habits, and physical inactivity. This increases the demand for fibrate drugs, including fenofibrate[3].

Market Segmentation

By Drug Type

The fenofibrate segment is expected to dominate the market, driven by its high efficacy and the increasing number of patients suffering from hypercholesterolemia. Fenofibrate is projected to command a significant market share due to its ability to maintain steady-state levels of cholesterol and fatty acids over a 6-8 month period[1][3][4].

By Distribution Channel

Hospital pharmacies currently hold the largest share of the fibrate drugs market, including fenofibrate. This is due to the comprehensive care and monitoring provided in hospital settings, which is crucial for managing the effects of these medications[1].

By Region

North America and Europe are key regions driving the market growth for fenofibrate, largely due to large-scale production and the presence of major market players like Abbott[1].

Branded vs. Generic Market Dynamics

Branded Formulations

Abbott's branded fenofibrate formulations have maintained a significant market share despite the availability of generic versions. This is attributed to a complex strategy involving sequential launches of branded reformulations and patent litigation that delays the approval of generics. These branded formulations, although more expensive, continue to dominate the market due to their perceived safety and effectiveness[2][3].

Generic Competition

Generic fenofibrate has been available since 2002, but the market share of branded formulations remains high. If all patients using branded fenofibrate were to switch to generic versions, the healthcare system could realize annual savings of approximately $700 million[2].

Financial Trajectory

Revenue Projections

The fenofibrate segment is expected to contribute significantly to the overall revenue of the fibrate drugs market. The market size for fibrate drugs, including fenofibrate, is projected to grow from $3.34 billion in 2024 to $5.04 billion by 2032[3].

Cost Implications

The continued use of branded fenofibrate formulations imposes a substantial cost on the healthcare system. The annual cost savings from switching to generic formulations could exceed $700 million, highlighting the financial implications of market dynamics in this sector[2].

Key Market Players and Competitive Insights

Major players like Abbott and Lupin Pharmaceuticals play a crucial role in the fenofibrate market. Abbott's dominance is maintained through its branded formulations and strategic patent management. Lupin Pharmaceuticals has also entered the market with generic fenofibrate capsules, increasing competition and potentially altering market dynamics in the future[2][4].

Challenges and Opportunities

Regulatory Framework

Stringent regulatory frameworks and frequent product recalls/discontinuations are expected to hinder market growth. However, the launch of new effective fibrate drugs and the increasing focus on treating cardiovascular diseases present opportunities for market expansion[4].

Research and Development

Rising research and development activities for managing high triglyceride levels will contribute to the growth of the fenofibrate market. New formulations and improved delivery methods could further enhance the market's potential[3].

Key Takeaways

• The fenofibrate market is expected to grow significantly, driven by the increasing prevalence of cardiovascular diseases and the drug's high efficacy.
• Branded formulations continue to dominate the market despite the availability of generics, due to strategic marketing and patent management.
• The market is projected to reach $5.04 billion by 2032, with the fenofibrate segment commanding a major share.
• Switching to generic formulations could result in substantial cost savings for the healthcare system.
• Key market players like Abbott and Lupin Pharmaceuticals are shaping the market through their product offerings and strategic moves.

FAQs

Q: What is the primary driver of the fenofibrate market growth? A: The primary driver is the increasing prevalence of cardiovascular diseases associated with high triglyceride levels and low cholesterol.

Q: Why do branded fenofibrate formulations maintain a significant market share despite generic availability? A: Branded formulations maintain their share due to a complex strategy involving sequential launches of new formulations and patent litigation that delays generic approvals.

Q: What are the potential cost savings from switching to generic fenofibrate? A: The healthcare system could realize annual savings of approximately $700 million by switching from branded to generic fenofibrate.

Q: Which regions are driving the growth of the fenofibrate market? A: North America and Europe are key regions driving the market growth due to large-scale production and the presence of major market players.

Q: What are the challenges facing the fenofibrate market? A: Stringent regulatory frameworks and frequent product recalls/discontinuations are expected to hinder market growth.

Cited Sources:

1. Maximize Market Research - Fibrate Drugs Market: Global Industry Analysis and Forecast (2023-2029)
2. PMC - How Abbott's Fenofibrate Franchise Avoided Generic Competition
3. Polaris Market Research - Fibrate Drugs Market Size, Demand, Trends, Report, 2024-2032
4. Mordor Intelligence - Fibrate Drugs Market - Size, Share & Statistics