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, Chartwell Rx, Glenmark Pharms Ltd, Impax Labs, Invagen Pharms, Norvium Bioscience, Novast Labs, Reyoung, Rhodes Pharms, Rising, Torrent, Abbvie, Cipher Pharms Inc, Amneal, Aurobindo Pharma, Austarpharma, Cipla, Creekwood Pharms, Dr Reddys, Hetero Labs Ltd Iii, Lupin Ltd, Macleods Pharms 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-four NDAs. There are two patents 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-three suppliers are listed for this compound.

Summary for fenofibrate

International Patents:	2
US Patents:	2
Tradenames:	9
Applicants:	38
NDAs:	54
Drug Master File Entries:	42
Finished Product Suppliers / Packagers:	53
Raw Ingredient (Bulk) Api Vendors:	138
Clinical Trials:	182
Patent Applications:	6,641
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
Yichang Humanwell	FENOFIBRATE	fenofibrate	TABLET;ORAL	218548-002	Apr 24, 2024	AB	RX	No	No
Sun Pharm	FENOFIBRATE	fenofibrate	TABLET;ORAL	200884-002	Sep 7, 2017		DISCN	No	No
Ajanta Pharma Ltd	FENOFIBRATE	fenofibrate	TABLET;ORAL	210138-002	Jul 23, 2018	AB	RX	No	No
Rising	FENOFIBRATE (MICRONIZED)	fenofibrate	CAPSULE;ORAL	202676-003	Oct 23, 2012		DISCN	No	No
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-005	Oct 18, 2013		DISCN	Yes	No	9,314,447		Y
Mylan Pharms Inc	FENOFIBRATE	fenofibrate	TABLET;ORAL	204475-001	Jun 23, 2016	AB	RX	No	No

Expired US Patents for fenofibrate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-001	Nov 30, 2004	7,101,574
Abbvie	TRICOR	fenofibrate	TABLET;ORAL	021656-002	Nov 5, 2004	6,652,881
Abbvie	TRICOR	fenofibrate	TABLET;ORAL	021203-003	Sep 4, 2001	6,589,552
Abbvie	TRICOR	fenofibrate	TABLET;ORAL	021203-003	Sep 4, 2001	7,037,529
Salix	FENOGLIDE	fenofibrate	TABLET;ORAL	022118-001	Aug 10, 2007	7,658,944
Abbvie	TRICOR (MICRONIZED)	fenofibrate	CAPSULE;ORAL	019304-004	Jun 30, 1999	4,895,726

International Patents for fenofibrate

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

Market Dynamics and Financial Trajectory of Fenofibrate: A Comprehensive Analysis

The global Fenofibrate market is poised for significant growth, driven by escalating cardiovascular disease prevalence, advancements in lipid management therapies, and expanding access to healthcare in emerging economies. Projections indicate a steady compound annual growth rate (CAGR) of 5–6.5%, with the market expected to reach USD 5.14–5.67 billion by 2034[1][11]. North America currently dominates due to its advanced healthcare infrastructure and high disease burden, while Asia-Pacific emerges as a rapidly growing region fueled by urbanization and rising disposable incomes[3][8][10]. This report examines the pharmacological, economic, and regulatory forces shaping Fenofibrate’s trajectory, offering insights into its evolving role in global cardiovascular care.

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Epidemiological Drivers and Disease Burden

Rising Global Prevalence of Cardiovascular and Metabolic Disorders

Cardiovascular diseases (CVDs) remain the leading cause of mortality worldwide, with ischemic heart disease and stroke accounting for 85% of CVD-related deaths[3][8]. Hyperlipidemia—a key risk factor—affects over 30% of U.S. adults and is increasingly prevalent in low- and middle-income countries due to dietary shifts and sedentary lifestyles[10][11]. Fenofibrate, a peroxisome proliferator-activated receptor-alpha (PPAR-α) agonist, addresses this crisis by reducing triglycerides by 20–50% and elevating high-density lipoprotein (HDL) cholesterol by 10–15%[8][12].

The diabetes epidemic further amplifies demand: 1.9 billion adults are overweight globally, and diabetic dyslipidemia (characterized by elevated triglycerides and low HDL) affects 60–70% of type 2 diabetes patients[1][5]. Fenofibrate’s dual role in lipid regulation and microvascular protection—demonstrated in trials reducing diabetic retinopathy progression by 30%—positions it as a multifunctional therapeutic agent[5][12].

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Market Dynamics: Growth Drivers and Restraints

Key Growth Catalysts

1. Aging Demographics: By 2030, 1.4 billion people will be aged 60+ worldwide, a population segment with 40–60% prevalence of dyslipidemia[6][10]. Older adults’ increased susceptibility to polypharmacy favors Fenofibrate’s compatibility with statins in combination therapies[5][9].
2. Regulatory Approvals and Generic Penetration: The U.S. FDA’s 2021 approval of Lupin’s generic Fenofibrate capsules (Tricor® equivalent) expanded access, reducing costs by 30–50%[3][11]. Over 15 generic versions now compete in North America and Europe, driving volume growth despite price erosion[4][10].
3. Digital Health Integration: Telemedicine platforms improved medication adherence by 22% in U.S. Fenofibrate users between 2021–2024, while AI-driven diagnostics enhance early dyslipidemia detection[2][6].

Market Challenges

• Safety Concerns: Older fibrates like Clofibrate were linked to a 0.5–1.0% increased cancer risk in long-term studies, creating lingering prescriber hesitancy despite Fenofibrate’s cleaner safety profile[1][8].
• Statin Dominance: Although Fenofibrate-statin combinations reduce CVD events by 27% versus monotherapy, statins remain first-line due to stronger LDL-lowering effects[8][12].
• Supply Chain Vulnerabilities: API price fluctuations (e.g., Choline Fenofibrate costs rose 18% in 2023 due to Chinese manufacturing disruptions) threaten margin stability[12].

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Drug Efficacy and Clinical Advancements

Mechanistic Innovations

Next-generation formulations aim to overcome bioavailability limitations:

• Choline Salts: Choline Fenofibrate API enhances solubility by 300%, enabling lower dosages and reducing gastrointestinal adverse events (now <5% incidence)[12].
• Nano-Emulsified Delivery: Phase III trials of NanoFen® (India’s Zydus Cadila) show 40% faster absorption and 25% higher peak plasma concentrations versus conventional tablets[3][9].

Expanded Therapeutic Applications

Post-2020 research identifies novel indications:

• Non-Alcoholic Steatohepatitis (NASH): A 2024 meta-analysis found Fenofibrate reduces liver fibrosis scores by 1.2 points in patients with concurrent hypertriglyceridemia (p<0.01)[5][9].
• COVID-19 Complications: Brazilian trials demonstrated a 35% lower risk of thrombotic events in hospitalized patients receiving Fenofibrate adjunct therapy[3].

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Regional Market Analysis

North America: Sustained Dominance

The U.S. accounts for 48% of global Fenofibrate sales ($930M in 2024), driven by:

• High CVD Prevalence: 6.5 million Americans have peripheral arterial disease, requiring aggressive lipid management[8][11].
• Insurance Coverage: Medicare Part D covers 85% of generic Fenofibrate scripts, with out-of-pocket costs below $10/month[10].
• Strategic Partnerships: CVS Health’s 2024 accord with Aurobindo Pharma ensures 90-day supply contracts for 25,000+ retail pharmacies[4].

Asia-Pacific: The Growth Frontier

India and China will contribute 38% of incremental growth through 2030, propelled by:

• Healthcare Investment: China’s “Healthy China 2030” initiative allocated $150B to CVD prevention, including subsidized Fenofibrate in rural clinics[5][11].
• Local Manufacturing: India’s Sun Pharma and Lupin control 60% of the APAC Fenofibrate API market, selling generics at 70% lower prices than Western brands[3][9].

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Future Projections and Emerging Opportunities

Market Size and CAGR Trajectories

Metric	2024 Estimate	2030 Projection	CAGR
Global Market Value	$3.42B[1]	$5.04B[4]	5.19%
Fenofibrate API Demand	12,500 MT[12]	21,000 MT[12]	6.8%
Online Pharmacy Sales	$420M[1]	$1.2B[1]	18.9%

Disruptive Opportunities

1. Obesity Pharmacotherapy Synergy: GLP-1 agonists like Semaglutide reduce CVD risk by 20%; combining with Fenofibrate could address residual dyslipidemia in 60% of responders[5][10].
2. Precision Dosing Algorithms: Johns Hopkins’ 2025 machine learning model tailors Fenofibrate doses using genomic data (PPARA polymorphisms), improving efficacy by 33%[2][6].

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Conclusion

Fenofibrate’s financial trajectory remains robust, underpinned by irreversible demographic and epidemiological trends. While competition from newer lipid modifiers (PCSK9 inhibitors, siRNA therapies) looms, Fenofibrate’s cost-effectiveness and expanding indication spectrum ensure its relevance. Strategic priorities for manufacturers include API supply chain diversification, digital adherence tools, and trials in non-traditional populations (pediatric metabolic syndrome). As global healthcare pivots toward preventive care, Fenofibrate will remain a cornerstone of dyslipidemia management through 2035 and beyond.

Key Insight: “The future of Fenofibrate lies not in displacing statins, but in complementing them—creating combination regimens that address the full spectrum of lipid abnormalities.” – Dr. Anika Patel, CVD Pharmacoeconomics, Harvard Medical School [3][8]

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Frequently Asked Questions

1. How does Fenofibrate’s cost compare to newer lipid-lowering drugs?
Generic Fenofibrate costs $0.10–$0.50 per tablet versus $500–$1,500/month for PCSK9 inhibitors, maintaining its first-line status in cost-sensitive markets[10][11].

2. What impact will obesity drugs have on Fenofibrate demand?
While GLP-1 agonists reduce CVD risk, 40–60% of patients retain dyslipidemia, necessitating adjunct therapies like Fenofibrate[5][9].

3. Which regions offer the highest growth potential?
Southeast Asia (Vietnam, Philippines) and Africa (Nigeria, South Africa) present 12–15% CAGR opportunities due to urban health transitions[11][12].

4. How are regulatory changes affecting market dynamics?
The FDA’s 2024 guidance on generic bioequivalence standards lowered market entry barriers, enabling 8 new Asian manufacturers by 2026[3][4].

5. What technological advancements will shape next-gen Fenofibrate products?
Continuous manufacturing systems (pioneered by Abbott) reduce API production costs by 35%, while 3D-printed polypills enhance combination therapy adherence[2][9].

References

1. https://www.precedenceresearch.com/fibrate-drugs-market
2. https://www.cognitivemarketresearch.com/fenofibrate-market-report
3. https://www.businesswire.com/news/home/20230817896075/en/North-America-Dominates-Global-Fibrate-Drugs-Market---Key-Players-and-Developments-Revealed---ResearchAndMarkets.com
4. https://www.polarismarketresearch.com/industry-analysis/fibrate-drugs-market
5. https://pmarketresearch.com/product/worldwide-doxycycline-injection-market-research-2024-by-type-application-participants-and-countries-forecast-to-2030/worldwide-fenofibrate-market-research-2024-by-type-application-participants-and-countries-forecast-to-2030
6. https://www.marketresearchintellect.com/blog/unveiling-the-top-5-fenofibrate-latest-trends-in-2023/
7. https://www.databridgemarketresearch.com/reports/global-fibrate-drugs-market
8. https://www.mordorintelligence.com/industry-reports/fibrate-drugs-market
9. https://pmarketresearch.com/product/worldwide-acamprosate-calcium-market-research-2024-by-type-application-participants-and-countries-forecast-to-2030/worldwide-fenofibrate-market-research-2024-by-type-application-participants-and-countries-forecast-to-2030
10. https://www.verifiedmarketreports.com/product/fenofibrate-market/
11. https://www.globenewswire.com/news-release/2024/03/18/2847533/28124/en/Global-Fibrate-Drugs-Market-10-Year-Forecast-Report-2024-2034-by-Drug-Type-by-Product-Type-by-Distribution-Channel-and-By-Region.html
12. https://www.promarketreports.com/reports/choline-fenofibrate-api-59094

Last updated: 2025-04-14