TRICOR (MICRONIZED) Drug Patent Profile

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

Tricor (micronized) is a drug marketed by Abbvie and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Tricor (micronized)

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

Summary for TRICOR (MICRONIZED)

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	138
Patent Applications:	4,099
DailyMed Link:	TRICOR (MICRONIZED) at DailyMed

US Patents and Regulatory Information for TRICOR (MICRONIZED)

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	TRICOR (MICRONIZED)	fenofibrate	CAPSULE;ORAL	019304-002	Feb 9, 1998		DISCN	Yes	No
Abbvie	TRICOR (MICRONIZED)	fenofibrate	CAPSULE;ORAL	019304-003	Jun 30, 1999		DISCN	Yes	No
Abbvie	TRICOR (MICRONIZED)	fenofibrate	CAPSULE;ORAL	019304-004	Jun 30, 1999		DISCN	Yes	No

Expired US Patents for TRICOR (MICRONIZED)

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	TRICOR (MICRONIZED)	fenofibrate	CAPSULE;ORAL	019304-002	Feb 9, 1998
Abbvie	TRICOR (MICRONIZED)	fenofibrate	CAPSULE;ORAL	019304-004	Jun 30, 1999
Abbvie	TRICOR (MICRONIZED)	fenofibrate	CAPSULE;ORAL	019304-003	Jun 30, 1999

International Patents for TRICOR (MICRONIZED)

See the table below for patents covering TRICOR (MICRONIZED) around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	2250327
Canada	960670	PHENOXY-ALKYL-CARBOXYLIC ACID DERIVATIVES AND THE PREPARATION THEREOF
United Kingdom	1268321

TRICOR (MICRONIZED) Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of TRICOR (Fenofibrate)

Introduction

TRICOR, a brand name for the drug fenofibrate, has been a significant player in the lipid-lowering medication market for several decades. Here, we will delve into the market dynamics and financial trajectory of TRICOR, highlighting its unique positioning, regulatory strategies, and economic impact.

Indications and Clinical Use

TRICOR is indicated as an adjunctive therapy to diet for reducing elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol, triglycerides, and apolipoprotein B (Apo B), and for increasing high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia or mixed dyslipidemia. It is also used for treating severe hypertriglyceridemia[2].

Market Dominance Through Reformulations

One of the key strategies that have contributed to TRICOR's market dominance is the continuous introduction of new formulations. Abbott, the original manufacturer, has successfully launched multiple generations of TRICOR, each with distinct characteristics that prevented generic substitution.

• Tricor-1 to Tricor-2: After the initial formulation (Tricor-1) became susceptible to generic competition, Abbott introduced Tricor-2, which did not face generic competition at launch due to ongoing patent litigation and differences in dosing[3].
• Tricor-2 to Tricor-3: Similarly, when generic versions of Tricor-2 were about to be approved, Abbott launched Tricor-3, which again prevented pharmacists from substituting with generics due to different dosages[3].

Financial Impact

The strategy of introducing new formulations has significantly impacted the financial trajectory of TRICOR.

• Sales Growth: Despite the availability of generic versions, branded formulations of TRICOR have continued to dominate the market, leading to substantial sales growth. By 2006, sales of Abbott’s fibrate franchise, including TRICOR, had eclipsed $1 billion and were expected to reach nearly $1.4 billion by 2011[3].
• Cost Implications: The continued use of branded formulations over generics has resulted in higher drug costs. If all patients switched to generic fenofibrate, the healthcare system could realize annual savings of approximately $700 million[3].

Regulatory Maneuvers

Abbott's ability to navigate regulatory challenges has been crucial in maintaining TRICOR's market position.

• Patent Litigation: Abbott has used patent infringement suits to delay the approval of generic versions, protecting its branded products from competition. For example, litigation delayed the approval of a generic version of Tricor-1 by 30 months[3].
• Bioequivalence and Dosing: New formulations like Tricor-2 and Tricor-3 were approved based on bioequivalence data with previous formulations but had different dosages, preventing generic substitution[3].

Clinical Trials and Labeling Changes

The outcomes of clinical trials have also influenced the market dynamics and labeling of TRICOR.

• ACCORD Lipid Study: The Action to Control Cardiovascular Risk in Diabetes Lipid (ACCORD Lipid) trial showed a non-significant reduction in major adverse cardiovascular events (MACE) but significant reductions in total cardiovascular disease events. However, this did not slow sales growth[2][4].
• Labeling Changes: Following the ACCORD Lipid Study, the FDA incorporated new data into the labeling, highlighting that no incremental benefit of fenofibrate on cardiovascular morbidity and mortality over statin monotherapy had been established. Despite this, the belief in the efficacy of fenofibrate persists among some healthcare professionals[4].

Generic Competition and Withdrawals

Despite the dominance of branded formulations, there have been attempts to introduce generic versions.

• Generic Availability: Generic versions of fenofibrate have been available since 2002, but they have not significantly impacted the market share of branded products due to the strategies employed by Abbott[3].
• Withdrawal of Approvals: The NDA for Tricor (Micronized) was voluntarily withdrawn, and there are no approved ANDAs referencing this formulation. This further solidifies the position of newer branded formulations[4].

Economic and Healthcare Implications

The market dynamics of TRICOR have significant economic and healthcare implications.

• Healthcare Costs: The continued use of branded formulations imposes substantial costs on the healthcare system. If all patients switched to generics, the system could save approximately $700 million annually[3].
• Patient Access: The high cost of branded medications can limit patient access to necessary treatments, highlighting the need for balanced pricing strategies that consider both innovation and affordability.

Key Takeaways

• TRICOR's market dominance is largely due to the strategic introduction of new formulations that prevent generic substitution.
• The financial trajectory of TRICOR has been marked by significant sales growth despite the availability of generic alternatives.
• Regulatory maneuvers, including patent litigation and bioequivalence data, have protected TRICOR from generic competition.
• Clinical trials and labeling changes have influenced the perception and use of TRICOR but have not significantly altered its market position.
• The economic implications of TRICOR's market dynamics include higher healthcare costs and potential limitations in patient access.

FAQs

What are the primary indications for TRICOR?

TRICOR is indicated as adjunctive therapy to diet to reduce elevated LDL-C, total cholesterol, triglycerides, and Apo B, and to increase HDL-C in patients with primary hypercholesterolemia or mixed dyslipidemia. It is also used for treating severe hypertriglyceridemia[2].

How has Abbott maintained TRICOR's market dominance?

Abbott has maintained TRICOR's market dominance through the introduction of new formulations, patent litigation, and ensuring that new formulations are not substitutable with generics due to different dosages[3].

What is the financial impact of using branded TRICOR over generic fenofibrate?

The continued use of branded TRICOR formulations instead of generic fenofibrate results in higher drug costs, with potential annual savings of approximately $700 million if all patients switched to generics[3].

How have clinical trials influenced the labeling and use of TRICOR?

Clinical trials such as the ACCORD Lipid Study have led to labeling changes, highlighting that no incremental benefit of fenofibrate on cardiovascular morbidity and mortality over statin monotherapy has been established. However, the belief in fenofibrate's efficacy persists among some healthcare professionals[4].

What are the economic and healthcare implications of TRICOR's market dynamics?

The high cost of branded TRICOR formulations imposes significant costs on the healthcare system and can limit patient access to necessary treatments, emphasizing the need for balanced pricing strategies[3].

Sources

1. PDR.Net - Tricor - Drug Summary
2. FDA - TRICOR (fenofibrate) Tablet, for oral use
3. PMC - How Abbott's Fenofibrate Franchise Avoided Generic Competition
4. FDA - Withdrawal of Approval of 44 New Drug Applications and 158 Abbreviated New Drug Applications
5. CVS - Fenofibrate micronized CAP 200mg - Tricor, triglide