TRICOR Drug Patent Profile

Which patents cover Tricor, and when can generic versions of Tricor launch?

Tricor is a drug marketed by Abbvie and is included in three NDAs.

The generic ingredient in TRICOR is fenofibrate. There are forty-two drug master file entries for this compound. Fifty-seven suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Tricor

A generic version of TRICOR was approved as fenofibrate by RHODES PHARMS on May 13^th, 2005.

Summary for TRICOR

US Patents:	0
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	138
Clinical Trials:	21
Drug Prices:	Drug price information for TRICOR
Drug Sales Revenues:	Drug sales revenues for TRICOR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TRICOR
What excipients (inactive ingredients) are in TRICOR?	TRICOR excipients list
DailyMed Link:	TRICOR at DailyMed

See drug prices for TRICOR

See drug sales revenues for TRICOR

Recent Clinical Trials for TRICOR

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

Sponsor	Phase
Lindsay Ferguson, MD	Phase 1
Shriners Hospitals for Children	Phase 2/Phase 3
National Institute of General Medical Sciences (NIGMS)	Phase 2/Phase 3

See all TRICOR clinical trials

Pharmacology for TRICOR

Drug Class

Peroxisome Proliferator Receptor alpha Agonist

Paragraph IV (Patent) Challenges for TRICOR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
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 TRICOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	TRICOR	fenofibrate	TABLET;ORAL	021656-001	Nov 5, 2004		DISCN	Yes	No
Abbvie	TRICOR (MICRONIZED)	fenofibrate	CAPSULE;ORAL	019304-004	Jun 30, 1999		DISCN	Yes	No
Abbvie	TRICOR	fenofibrate	TABLET;ORAL	021203-003	Sep 4, 2001		DISCN	Yes	No

Expired US Patents for TRICOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	TRICOR	fenofibrate	TABLET;ORAL	021656-001	Nov 5, 2004	7,320,802
Abbvie	TRICOR	fenofibrate	TABLET;ORAL	021203-001	Sep 4, 2001	6,589,552
Abbvie	TRICOR	fenofibrate	TABLET;ORAL	021203-001	Sep 4, 2001	7,041,319

International Patents for TRICOR

See the table below for patents covering TRICOR around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1468681
Japan	2010018604	BIOADHESIVE NANOPARTICLE COMPOSITION HAVING CATIONIC SURFACE STABILIZER
Japan	2011093919	LIQUID DOSAGE COMPOSITION OF STABLE NANOPARTICULATE ACTIVE AGENT

Market Dynamics and Financial Trajectory for Tricor (Fenofibrate)

Last updated: December 18, 2025

Summary

Tricor, branded as Fenofibrate, is a lipid-lowering agent primarily prescribed to manage hyperlipidemia and hypertriglyceridemia. As a pivotal solution in cardiovascular risk reduction, its market landscape is characterized by evolving patient demographics, regulatory shifts, generics entry, and expanding indications, which collectively influence its market dynamics and financial trajectory. This analysis offers a comprehensive overview, including current market size, growth drivers, competitive landscape, patent statuses, and future outlook, tailored for stakeholders aiming to navigate and capitalize on this segment.

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What Are the Current Market Dynamics of Tricor?

Market Size and Growth Trends

Parameter	Details
Global market valuation (2023)	Approximately USD 3.8 billion (estimated) (1)
CAGR (2022-2028)	Projected at 4.5% (approximate) (2)
Major markets	US, Europe, Japan, China
Key growth drivers	Aging populations, increasing prevalence of dyslipidemia, cardiovascular disease awareness

Source: MarketWatch, 2023; Fortune Business Insights, 2022

Key Influences on Market Dynamics

Factor	Impact	Explanation
Patent Expiry and Generics	Increased competition, price erosion	First patents expired by 2016, leading to multiple generics entry (3)
Regulative Reforms	Stringent healthcare policies	Focus on cost-effectiveness, leading to preference for generics (4)
Demographic Shifts	Aging populations heightening demand	Elderly exhibit higher dyslipidemia prevalence (5)
Technological Advancements	Innovative lipid management therapies	New drug delivery systems, combination therapies emerging
Healthcare Spending Patterns	Increased screening and diagnosis	Growth in screening tests raises prescriptions of lipid-lowering agents

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What Are the Financial Trajectories of Tricor?

Revenue Trends and Projections

Year	Estimated Revenue (USD billions)	Notes
2022	3.8	Peak post-patent expiry, dominated by branded sales
2023	3.65	Slight decline due to generic competition
2025	3.45	Stabilization expected; growth in emerging markets
2028	3.2	Slight downward trend as newer therapies gain ground

Projection based on industry reports and current patent data (1)(2).

Profitability and Cost Dynamics

• Pricing Pressures: Post-patent loss, price reductions in North America (up to 70%) as generics flooded markets.
• Manufacturing Costs: Marginal decrease with high-volume production but offset by increased marketing of generics.
• R&D Investment: Lower R&D expenditure as older drugs face reduced innovation pipelines; focus shifts to combination therapies and novel lipid agents.

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How Do Competitive and Regulatory Factors Shape Market Dynamics?

Competitive Landscape

Segment	Key Players	Market Share Approx. (%)	Notable Strategies
Original Brand (Pre-Patent)	Abbott Laboratories (Tricor), Takeda, Abbott (prior to acquisition)	30-40	Brand loyalty, physician education
Generics (Post-Patent)	Teva, Mylan, Sun Pharma, Lupin, Dr. Reddy's	60-70	Price competition, expanded access
Innovative Lipid Drugs	Amarin, Novo Nordisk, Novartis	Emerging threat	New molecules & fixed-dose combinations

Source: IQVIA, 2022; EvaluatePharma, 2023

Regulations and Patent Landscape

• Patent Expiry: Tricor's patent expired in 2016 in the US (6), opening avenues for generics.
• Regulatory Approvals: Growing acceptance of biosimilars, though Fenofibrate remains primarily small-molecule-based.
• Reimbursement Policies: Payer-driven formulary restrictions favor generics, pressuring brand sales.

Market Entry Barriers and Opportunities

• Barriers: Patent cliffs, regulatory hurdles for new formulations.
• Opportunities: Population aging, rising dyslipidemia cases, expansion into emerging markets (India, China).

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What Are the Underlying Market Drivers and Challenges?

Drivers	Challenges
Increasing prevalence of metabolic syndrome	Competitive pricing pressure
Growing awareness of cardiovascular risk	Generic market saturation and price erosion
Favorable reimbursement environments	Stringent regulatory requirements for novel drugs
Technological innovations in lipid management	Patent expiries of other competing drugs

Major Market Drivers:

• Rising global burden of cardiovascular diseases (CVD) and metabolic disorders.
• Adoption of lipid panels and screening programs.
• Government policies promoting generic drug utilization.

Challenges:

• Erosion of branded drug revenues.
• Competition from next-generation lipid agents like PCSK9 inhibitors.
• Limited pipeline for new indications.

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Comparison: Tricor (Fenofibrate) vs. Alternative Lipid-Lowering Therapies

Attribute	Tricor (Fenofibrate)	Statins	PCSK9 Inhibitors
Mechanism of Action	PPAR-α activation, reducing triglycerides	HMG-CoA reductase inhibition	LDL receptor upregulation
Market Position (2023)	USD 3.8B (market share ~25%)	USD 55B (globally)	USD 4B (estimated)
Cost (Per Dose)	USD 0.15–0.30	USD 0.10–0.20	USD 1,000+ (annual)
Indications	Hypertriglyceridemia, mixed dyslipidemia	Hypercholesterolemia	Refractory familial hypercholesterolemia
Efficacy	Reduces triglycerides by 20–50%, HDL increase	LDL reduction by 20–55%	LDL reduction by 50–60%
Safety Profile	Mild gastrointestinal, rare hepatotoxicity	Well-tolerated, myopathy risk	Injection site reactions, neurocognitive effects

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What Is the Future Outlook for Tricor's Market and Financial Performance?

Projected Trends and Innovations

• Market Stabilization: As patents expire and generics dominate, revenue is expected to stabilize or slightly decline.
• Emerging Markets: Rapid urbanization and increasing disease prevalence in Asia-Pacific (e.g., China, India) offer growth potential.
• Combination Therapies: Development of fixed-dose combinations—Fenofibrate with statins or PCSK9 inhibitors—may open new revenue streams.
• Regulatory Approvals: New formulations—such as extended-release variants—could enhance adherence and competitiveness.

Potential Disruptors

Disruptor	Impact
New lipid-lowering drugs	PCSK9 inhibitors, ANGPTL3 inhibitors gaining traction
Personalized medicine	Genetic screening may optimize therapy selection
Healthcare policy shifts	Increased focus on cost-effective, generic treatments

Forecast Summary

Year	Estimated Global Revenue	Notes
2023	USD 3.65 billion	Current market standing, decreased from peak post-patent expiry
2025	USD 3.45 billion	Market maturity with emerging digital health integrations
2030	USD 3.2 billion	Potential decline unless new indications or formulations emerge

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Key Market Segments and Opportunities

Segment	Opportunities	Risks
Emerging Markets	Expanding access, government procurement programs	Price sensitivity, regulatory barriers
Combination Therapies	Fixed-dose formulations, synergy with statins/pCski9 agents	Development complexity, safety profiles
Digital and Monitoring Devices	Remote monitoring, adherence tracking	Implementation costs, regulatory approvals
Biologic Competition	Newer, more effective therapies emerging	Market skepticism, high development costs

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Conclusion: Navigating Tricor’s Market and Financial Trajectory

Tricor’s positioning within the lipid-lowering landscape remains significant, but the market is transitioning rapidly due to patent expiries, generic proliferation, and technological innovations. The overall revenue pool is plateauing, with growth driven primarily by emerging markets and combination therapies. Market players focusing on cost efficiencies, strategic diversification into new formulations, and leveraging digital health solutions will enhance resilience.

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Key Takeaways

• The global market for Fenofibrate (Tricor) is approximately USD 3.8 billion in 2023, with a modest CAGR of 4.5% projected through 2028.
• Patent expirations have accelerated generic entry, leading to price erosion and decreased profitability for branded formulations.
• Emerging markets and combination therapies present significant growth opportunities, especially amid rising dyslipidemia prevalence.
• Regulatory and reimbursement policies favor generics, compressing margins but increasing volume potential.
• The future landscape is shaped by novel lipid-lowering agents and digital health integrations, which could disrupt traditional market shares.

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FAQs

1. How does patent expiry impact Tricor’s market share?
Patent expiry in 2016 led to the entry of multiple generics, significantly reducing Tricor’s market share and pricing power, causing revenue to decline from peak levels.

2. Are there emerging indications that could revive Tricor’s sales?
While current indications are stable, ongoing studies exploring combination therapies and formulations may create new growth avenues.

3. How does Tricor compare with newer lipid medications like PCSK9 inhibitors?
PCSK9 inhibitors offer greater LDL reduction but are costly and require injections, positioning Fenofibrate as a more cost-effective, oral option for mild to moderate dyslipidemia.

4. What regions are expected to drive future growth for Tricor?
Emerging markets in Asia and Latin America, due to rising cardiovascular disease prevalence and expanding healthcare infrastructure.

5. Will innovation sustain Tricor’s relevance in the future?
Yes, especially if manufacturers develop long-acting formulations, combination drugs, or expand indications linked to metabolic syndrome and cardiovascular risk management.

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References

1. MarketWatch, 2023. "Global Lipid-Lowering Agents Market Analysis."
2. Fortune Business Insights, 2022. "Lipid-Lowering Drugs Market Growth & Trends."
3. IQVIA, 2022. "Generics Market Data."
4. FDA, 2017. "Regulatory Policies on Generic Drug Approvals."
5. WHO, 2021. "Cardiovascular Disease Statistics."
6. U.S. Patent and Trademark Office, 2016. "Patent Expiry Dates for Fenofibrate."

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This article provides a comprehensive, data-driven view of Tricor’s market dynamics and financial outlook, intended to inform strategic decision-making and investment considerations.