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Last Updated: December 11, 2025

TRICOR Drug Patent Profile


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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-six 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 13th, 2005.

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Drug patent expirations by year for TRICOR
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Recent Clinical Trials for TRICOR

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SponsorPhase
Lindsay Ferguson, MDPhase 1
The University of Texas Medical Branch, GalvestonPhase 2/Phase 3
Shriners Hospitals for ChildrenPhase 2/Phase 3

See all TRICOR clinical trials

Pharmacology for TRICOR
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 ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Abbvie TRICOR (MICRONIZED) fenofibrate CAPSULE;ORAL 019304-004 Jun 30, 1999 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Abbvie TRICOR fenofibrate TABLET;ORAL 021203-003 Sep 4, 2001 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>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 TRICOR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie TRICOR fenofibrate TABLET;ORAL 021656-002 Nov 5, 2004 6,652,881 ⤷  Get Started Free
Abbvie TRICOR fenofibrate TABLET;ORAL 021656-002 Nov 5, 2004 6,277,405 ⤷  Get Started Free
Abbvie TRICOR fenofibrate TABLET;ORAL 021656-001 Nov 5, 2004 7,276,249 ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: TRICOR

Last updated: November 20, 2025

Introduction

Tricor (generic name: fenofibrate) remains a leading therapeutic agent primarily prescribed for dyslipidemia—specifically, hyperlipidemia and hypertriglyceridemia. Since its approval, Tricor has sustained a significant market presence driven by expanding cardiovascular disease (CVD) prevalence and evolving lipid management guidelines. This article delineates the current market dynamics and forecasts the financial trajectory of Tricor within the broader pharmaceutical landscape, emphasizing its regulatory status, competitive environment, and emerging opportunities.

Regulatory History and Market Position

First approved by the FDA in 1998, Tricor was originally marketed by Abbott Laboratories, which later spun off its pharmaceutical assets into AbbVie. The drug has maintained market relevance through patent protections and orphan drug designations in certain markets, although patent expirations have begun to influence its sales trajectory.

In December 2019, the US patent for Tricor expired, facilitating the rise of generic fenofibrate products that have compounded competitive pressures. Despite this, branded formulations still command a segment of the market primarily due to formulary preferences and physician inertia. Regulatory approvals across other jurisdictions, such as the European Union, have bolstered its global footprint.

Market Dynamics Influencing Tricor

1. Rising Prevalence of Cardiovascular Diseases

The global surge in CVD, driven by sedentary lifestyles, obesity, and diabetes, has fueled demand for lipid-modulating therapies like fenofibrate. The World Health Organization (WHO) reports CVD as the leading cause of death worldwide, with millions requiring long-term lipid management. As awareness campaigns and screening programs expand, the demand for effective dyslipidemia treatments—including Tricor—continues to grow.

2. Shifting Lipid Management Guidelines

Clinical guidelines issued by entities such as the American Heart Association (AHA) and the American College of Cardiology (ACC) increasingly emphasize a comprehensive approach to lipid management. While statins remain the first-line therapy, fenofibrate is often recommended as an adjunct for patients with hypertriglyceridemia or mixed dyslipidemia, especially in those with metabolic syndrome. These developments sustain Tricor’s market relevance, though they also intensify competition from newer agents and combination therapies.

3. Patent Expirations and Generic Competition

The 2019 patent expiry marked a pivotal point, ushering in a proliferation of generic fenofibrate formulations. This significantly eroded branded sales and prompted manufacturers to seek differentiation through formulations, extended-release versions, and combination pills. The presence of multiple competitors—like Teva, Mylan, and Sandoz—has intensified price competition, compressing profit margins for brand-name providers.

4. Emerging Alternatives and Combination Therapies

Recent pharmaceutical innovations offer potent alternatives for lipid regulation. PCSK9 inhibitors, for instance, demonstrate superior LDL-cholesterol reduction but are cost-prohibitive for broad use. Similarly, newer fibrates, omega-3 fatty acid formulations, and combination agents pose competitive threats. Nonetheless, fenofibrate’s established safety profile and affordability sustain its demand, especially in developing markets.

5. Market Penetration in Emerging Economies

The expanding healthcare infrastructure in emerging markets such as India, Southeast Asia, and Latin America underpins future sales prospects. Affordability and increasing awareness of cardiovascular risk factors expand patient access, making these regions critical growth frontiers for fenofibrate products.

Financial Trajectory and Revenue Forecasts

Historical Performance

Post-patent expiry, branded Tricor experienced a rapid decline in sales, with estimates indicating a drop of approximately 50% in US revenues from peak levels in the early 2010s. According to IMS Health data, global Tricor sales fluctuated around $1.2 billion in 2017, with anecdotal reports suggesting a further decline post-2019 due to generic competition.

Current Market Channel Composition

Most current revenues derive from generic sales in the US and international markets. The gap left by branded sales serves as fertile ground for aggressive pricing strategies among generics manufacturers. Notably, the latency of new formulations and limited marketing of branded Tricor attenuates revenue growth potential.

Projected Trends (2023–2030)

  • ** revenue stabilization and modest growth in emerging markets owing to demographic shifts and increasing healthcare coverage.

  • Potential growth catalysts include formulation innovations, such as sustained-release versions, fixed-dose combination pills, and tailored therapies for subpopulations (e.g., diabetic patients).

  • Market share consolidation among generics is likely, with top players expanding footprints via local manufacturing.

  • Pricing pressures will persist under global cost-containment policies, dampening revenue expansion.

Based on current trends, industry analysts project a compound annual growth rate (CAGR) of approximately -2% to +1% for Tricor sales globally over the next decade, largely reflecting market saturation in mature markets and growth in emerging regions.

Implications of Patent and Regulatory Developments

The expiration of key patents catalyzed the proliferation of generics, which collectively now command over 80% of the fenofibrate market share. Future patent cliffs and regulatory approvals for potential new formulations or combination therapies could either diminish or enhance revenue streams depending on their market acceptance and pricing strategies.

Impact of Reimbursement Policies and Healthcare Economics

In jurisdictions like the US, the shift towards value-based care, coupled with formulary restrictions, has influenced prescription patterns. Favorable reimbursement for low-cost generics sustains their dominant market position, whereas branded drugs struggle unless they demonstrate significant clinical advantages. The upcoming biosimilar and biosimilar-like entries into lipid management may further shift dynamics.

Strategic Outlook

To optimize the financial trajectory, stakeholders should focus on:

  • Innovative formulations: Forecasting niche repositioning through sustained-release or combination drugs.

  • Market expansion: Accelerating penetration in low- and middle-income countries via partnerships and local manufacturing.

  • Regulatory agility: Securing approvals for novel indications or patient-specific formulations.

  • Cost leadership: Maintaining competitiveness in pricing amid increasing generic proliferation.

  • Portfolio diversification: Investing in next-generation lipid-lowering agents that could supplant fenofibrate in certain indications.

Key Takeaways

  • The post-patent landscape has posed existential challenges for branded Tricor, leading to revenue declines and increased generic competition.

  • The global increase in cardiovascular morbidity sustains long-term demand, particularly in emerging markets, but growth will be constrained by pricing pressures and alternative therapies.

  • Formulation innovation and expanding geographically are imperative for manufacturers seeking to preserve or grow revenues.

  • The future financial trajectory of Tricor hinges on strategic positioning within lipid management, regulatory landscape agility, and the evolving competitive environment.

  • Stakeholders must monitor ongoing developments in lipid therapy guidelines, patent statuses, and healthcare policies to refine market strategies.

FAQs

1. How will patent expirations affect Tricor’s revenue?
Patent expirations have led to widespread generic entry, eroding branded sales and intensifying price competition. While this diminishes revenue from branded Tricor, it also broadens the market access for generics, stabilizing overall fenofibrate sales but with lower profit margins for original patent holders.

2. Can clinical advantages of newer lipid therapies threaten Tricor’s market share?
Yes. Advancements like PCSK9 inhibitors and novel combination pills offer more potent lipid management, especially in high-risk strata. However, their high costs and specific indications limit widespread replacement of fenofibrate, which remains cost-effective for many patients.

3. What markets offer the most growth potential for fenofibrate products?
Emerging economies in Asia, Latin America, and Africa present significant growth prospects due to increasing cardiovascular disease burdens, expanding healthcare infrastructure, and affordability considerations.

4. Are there innovative formulations or combination therapies for fenofibrate on the horizon?
Yes. Companies are developing sustained-release versions, fixed-dose combinations with statins or other lipid-lowering agents, which could enhance adherence and clinical outcomes, potentially revitalizing market interest.

5. How do healthcare policies influence Tricor’s future prospects?
Reimbursement frameworks pushing for low-cost generics and value-based care tend to favor fenofibrate’s cost profile, bolstering its market share. Conversely, policies favoring novel, higher-cost therapies could further erode branded Tricor’s relevance.


References:

  1. [1] WHO. Cardiovascular Diseases (CVDs). World Health Organization. 2021.
  2. [2] American Heart Association. 2020 Guidelines for LDL-C Management.
  3. [3] IMS Health Data. 2017–2022.
  4. [4] U.S. Food and Drug Administration. Patent and exclusivity data for fenofibrate.
  5. [5] MarketWatch. "Global Fenofibrate Market Outlook." 2022.

(Note: This report is a synthesis based on publicly available industry data and does not encompass proprietary market intelligence.)

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