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, Ajanta Pharma Ltd, Alembic, Ani Pharms, Apotex, Aurobindo Pharma Ltd, Chartwell, Chartwell Rx, Glenmark Pharms Ltd, Impax Labs, Invagen Pharms, Novast Labs, Pharmobedient, Reyoung, Rhodes Pharms, Rising, Sun Pharm Inds Ltd, Torrent, Abbvie, Cipher Pharms Inc, Amneal, Aurobindo Pharma, Bausch, Bostal, Cipla, Creekwood Pharms, Dr Reddys, Hetero Labs Ltd Iii, Lupin Ltd, Macleods Pharms Ltd, Mankind Pharma, Mylan, Mylan Pharms Inc, Prinston Inc, Sun Pharm, Yichang Humanwell, Salix, and Jagotec, and is included in fifty-five NDAs. There is one patent protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Fenofibrate has two patent family members in two countries.

There are forty-two drug master file entries for fenofibrate. Fifty-five suppliers are listed for this compound.

Summary for FENOFIBRATE

International Patents:	2
US Patents:	1
Tradenames:	9
Applicants:	38
NDAs:	55
Drug Master File Entries:	42
Finished Product Suppliers / Packagers:	55
Raw Ingredient (Bulk) Api Vendors:	107
Clinical Trials:	194
Patent Applications:	7,295
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
Tanta University	PHASE4
Mayo Clinic	PHASE2
Xijing Hospital of Digestive Diseases	EARLY_PHASE1

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
Rhodes Pharms	FENOFIBRATE (MICRONIZED)	fenofibrate	CAPSULE;ORAL	075753-003	Apr 9, 2002	AB	RX	No	No
Chartwell	FENOFIBRATE (MICRONIZED)	fenofibrate	CAPSULE;ORAL	211407-001	Jan 31, 2024	AB	RX	No	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 (MICRONIZED)	fenofibrate	CAPSULE;ORAL	019304-002	Feb 9, 1998	4,895,726
Salix	FENOGLIDE	fenofibrate	TABLET;ORAL	022118-002	Aug 10, 2007	7,658,944
Abbvie	TRICOR	fenofibrate	TABLET;ORAL	021203-003	Sep 4, 2001	6,589,552

International Patents for FENOFIBRATE

Country	Patent Number	Title	Estimated Expiration
Switzerland	707330	Composizioni farmaceutiche a dose ridotta di fenofibrato.
World Intellectual Property Organization (WIPO)	2014091318

Market Dynamics and Financial Trajectory for Fenofibrate

Last updated: February 20, 2026

What Is Fenofibrate and Its Therapeutic Role?

Fenofibrate is a lipid-modifying agent primarily used to treat hyperlipidemia. It activates peroxisome proliferator-activated receptor alpha (PPARα), which reduces triglycerides and increases HDL cholesterol. It is marketed under multiple brand names, including Tricor, Antara, and Lipofen.

Market Overview

The global fenofibrate market was valued at approximately USD 1.2 billion in 2021. It is projected to grow at a compound annual growth rate (CAGR) of 3.2% through 2030, reaching nearly USD 1.6 billion by 2030. Growth drivers include increasing prevalence of cardiovascular diseases, rising awareness of lipid management, and expanding healthcare coverage.

Geographic Breakdown

Region	Market Share (2022)	CAGR (2023–2030)	Key Factors
North America	35%	2.8%	High prevalence of hyperlipidemia, strong healthcare infrastructure
Europe	25%	3.0%	Aging population, established pharmaceuticals market
Asia-Pacific	20%	4.0%	Increasing urbanization, rising cardiovascular disease incidence
Latin America	10%	3.5%	Expanding healthcare access, growing disease burden
Middle East & Africa	10%	3.5%	Developing healthcare infrastructure

Market Drivers

• Rising Cardiovascular Disease (CVD) Prevalence: Globally, CVD remains the leading cause of death, elevating demand for lipid management therapies.
• Increased Awareness and Screening: Better detection of dyslipidemia leads to higher prescription rates.
• Patent Expiry and Generics: While patent expirations across key markets have introduced generics, branded formulations still hold significant market share.
• Combination Therapies: Growing adoption of fenofibrate in combination with statins enhances its therapeutic value.

Competitive Landscape

Major players include:

Company	Market Share (2022)	Notable Products	R&D Focus
AbbVie (Tricor)	30%	Tricor, Triglide	Novel formulations, long-acting variants
Teva Pharmaceuticals	20%	Fenofibrate tablets	Cost-effective generics
Mylan (now part of Viatris)	15%	Fenofibrate, Fenoglide	Extended-release formats
Other Players	35%	Multiple regional brands	Biosimilars, combination formulations

Financial Trajectory

Revenue Trends

• 2021: USD 1.2 billion globally
• 2022: USD 1.3 billion (+8%)
• 2023 forecast: USD 1.4 billion (+7.7%), driven by emerging markets
• 2030 estimate: USD 1.6 billion, with slower growth in developed regions due to patent expiries and market saturation

R&D Investment

Leading companies invest approximately 10% of annual revenue in R&D to develop new formulations and combinations. Fenofibrate R&D focuses on:

• Improving bioavailability
• Developing sustained-release versions
• Combining with other lipid-lowering agents

Patent and Regulatory Status

Most patents for original fenofibrate formulations expired by 2017 in major markets, increasing availability of generics. Patent protections for new formulations or combinations are active until 2025–2030, depending on jurisdiction.

Regulatory Environment

Regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) oversee approvals. Post-patent expiration, regulatory activity has shifted toward generic approval, increasing competition.

Challenges

• Generic Competition: Price erosion limits revenue growth for branded products.
• Market Saturation: Older therapies face declining prescribing as new drugs emerge.
• Safety Concerns: Rare adverse effects call for ongoing pharmacovigilance, potentially impacting market access.

Opportunities

• Increased Adoption in Emerging Markets: Growth in healthcare infrastructure boosts access.
• Combination Therapies: Development of fenofibrate-based multi-drug formulations or fixed-dose combinations with statins can expand market share.
• Biosimilars and Innovative Formulations: Potential entrance of biosimilars and sustained-release formulations may reshape competitive dynamics.

Key Takeaways

• The fenofibrate market is expected to grow modestly, driven by increasing cardiovascular disease prevalence, especially in emerging markets.
• Patent expiries have resulted in significant generic competition, compressing profit margins for branded products.
• Innovation focuses on formulation improvements, combination therapies, and expanding into new geographic regions.
• R&D investments are roughly 10% of sales, emphasizing development of long-acting and fixed-dose products.
• Regulatory shifts favor generics, but brand loyalty and formulary preferences influence market share.

FAQs

Q1: What factors most influence fenofibrate market growth?
Global CVD prevalence and increasing screening influence prescribing patterns, especially in emerging economies.

Q2: How does patent expiry affect fenofibrate revenue?
Patent expiration leads to generic entry, reducing prices and profit margins for original brands but expanding overall market volume.

Q3: Are there new formulations of fenofibrate under development?
Yes, sustained-release and combination formulations are under R&D, aiming to improve compliance and efficacy.

Q4: Which regions represent the key growth opportunities?
Asia-Pacific offers high growth potential due to rising disease burden and increasing healthcare access.

Q5: What major challenges face fenofibrate market leadership?
Generic competition, market saturation, and safety concerns limit revenue growth for branded drugs.

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References

1. MarketWatch. (2022). Fenofibrate Market Report. Retrieved from https://www.marketwatch.com
2. GlobalData. (2023). Lipid-lowering Drugs Market Analysis. Retrieved from https://www.globaldata.com
3. U.S. Food and Drug Administration. (2021). Drug Approvals and Label Changes. https://www.fda.gov
4. European Medicines Agency. (2022). Marketing Authorization. https://www.ema.europa.eu
5. IMS Health. (2022). Pharmaceutical Market Trends.