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-five 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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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
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
Abbvie	TRICOR	fenofibrate	TABLET;ORAL	021203-001	Sep 4, 2001		DISCN	Yes	No

International Patents for TRICOR

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

Country	Patent Number	Title	Estimated Expiration
Estonia	9900296
Portugal	1273293
Hungary	208497	X-RAY-CONTRAST COMPOSITIONS FOR PRODUCING MEDICAL PICTURES
Spain	2195308

TRICOR Market Analysis and Financial Projection

Last updated: February 3, 2026

What is Tricor and What is its Market Position?

Tricor (fenofibrate) is a lipid-modifying agent licensed for the treatment of hypercholesterolemia and mixed dyslipidemia. It is primarily used to lower total cholesterol, LDL cholesterol, triglycerides, and increase HDL cholesterol. Tricor has been marketed globally since the 1990s, with its patent rights most notably held by Abbott Laboratories (now AbbVie after spin-off). Its primary competitors include drugs such as Lipitor (atorvastatin), Crestor (rosuvastatin), and other fibrates like Lopid (gemfibrozil).

What Are the Key Market Dynamics?

Market Size and Growth

The global market for lipid-modifying agents was valued at approximately $17 billion in 2022, with expectations to grow at an annual rate of 3–4% over the next five years. The rise stems from increasing cardiovascular disease (CVD) prevalence, aging populations, and expanding diagnosis rates.

Patent Expirations and Generic Competition

AbbVie's patent for Tricor expired in most markets by 2013, leading to a surge in generic fenofibrate availability. Generic drugs now account for over 80% of the total Tricor market in the U.S., significantly eroding brand sales.

Regulatory and Competitive Landscape

Brand-name Tricor faces competition from generics, over-the-counter (OTC) supplements, and new lipid-lowering therapies, including PCSK9 inhibitors and novel fibrates. Regulatory efforts have focused on demonstrating equivalence with generic formulations, but limited franchise growth remains.

What Are the Financials and Revenue Drivers?

Historical Sales and Revenue Decline

Post-patent expiry, Original Tricor's U.S. sales declined sharply from over $500 million in 2012 to under $50 million in 2022, due to price competition and generic substitution.

Current Market Share and Revenues

In markets where branded Tricor remains marketed, annual revenues range from $100–200 million, primarily driven by markets outside North America where generic penetration is less comprehensive.

R&D and Investment Output

AbbVie has divested or phased out Tricor-related R&D, focusing on novel lipid therapies and other cardiovascular drugs.

What Are the Investment Fundamentals and Outlook?

Commercial Viability

Given the dominance of generics, the commercial prospects for branded Tricor are limited outside niche markets or regions with limited generic penetration. New formulations or drug delivery methods have not significantly impacted the overall market size.

Development Pipeline and Innovation

No new formulations or significant pipeline updates are publicly associated with Tricor, reducing its future growth prospects.

Regulatory and Patent Strategy

Patent protection is expired, which limits ability to extend exclusivity in key markets. Regulatory challenges focus on demonstrating bioequivalence rather than novel mechanisms.

What Are the Risks and Opportunities?

Risks

• Market erosion from generics and OTC options.
• Competitive emergence of newer therapies, such as PCSK9 inhibitors, which may supplant fibrates for certain indications.
• Limited pipeline for Tricor-specific development.

Opportunities

• Potential for combination therapies or reformulations.
• Emerging markets with limited generic penetration.
• Strategic licensing or partnership opportunities for newer lipid-modulating agents.

What Do the Investment Fundamentals Suggest?

Tricor's decline in revenue and market share post-patent expiration indicates limited near-term upside in its core commercial form. Growth prospects are confined to markets with less generic competition or through formulations that extend patent life. The asset's value lies more in its legacy position and potential licensing in developing regions than in future revenue expansion within mature markets.

Key Takeaways

• Tricor's original patent expired in 2013, leading to significant revenue erosion through generic substitution.
• The drug now primarily generates modest revenues, predominantly outside North America.
• No significant pipeline or formulation innovations are publicly pursued to revitalize its market share.
• Competing therapies, including statins and PCSK9 inhibitors, overshadow fibrates in lipid management.
• Opportunities exist in emerging markets and through reformulated products, but the risk of continued decline remains high.

FAQs

1. Is Tricor still profitable for its manufacturers?
In mature markets, no. Revenue has declined sharply due to generics. In some regions, it still generates standalone revenues but no longer constitutes a significant profit center.

2. Are there new formulations or delivery methods in development?
No publicly available data indicates active development for Tricor-specific reformulations; the focus has shifted toward newer lipid therapies.

3. Could patent protection be regained through regulatory strategies?
No. Since patent expiration and bioequivalence studies enable generics to enter the market, regulatory strategies are unlikely to restore exclusivity.

4. How does Tricor compare financially with its competitors?
Compared to statins like Lipitor or Crestor, Tricor has significantly lower sales in its maturity phase, reflecting reduced market share and higher competition.

5. What is the outlook for lipid-modifying agents overall?
Growth slows due to market saturation and the rise of newer therapies. The long-term outlook favors innovation in drug mechanisms and personalized medicine rather than legacy fibrates like Tricor.

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Sources:
[1] EvaluatePharma. "Lipid Modifying Agents Market Report," 2022.
[2] U.S. FDA. Abbreviated New Drug Application (ANDA) approvals for fenofibrate products, 2013–2022.
[3] MarketsandMarkets. "Lipid Modifiers Market by Type, Application, and Region," 2023.