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-three 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:	4
Raw Ingredient (Bulk) Api Vendors:	138
Clinical Trials:	21
Patent Applications:	4,099
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
National Institute of General Medical Sciences (NIGMS)	Phase 2/Phase 3
The University of Texas Medical Branch, Galveston	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
Abbvie	TRICOR	fenofibrate	TABLET;ORAL	021203-001	Sep 4, 2001		DISCN	Yes	No
Abbvie	TRICOR	fenofibrate	TABLET;ORAL	021656-002	Nov 5, 2004		DISCN	Yes	No
Abbvie	TRICOR (MICRONIZED)	fenofibrate	CAPSULE;ORAL	019304-003	Jun 30, 1999		DISCN	Yes	No
Abbvie	TRICOR (MICRONIZED)	fenofibrate	CAPSULE;ORAL	019304-002	Feb 9, 1998		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	021203-001	Sep 4, 2001	7,041,319
Abbvie	TRICOR	fenofibrate	TABLET;ORAL	021656-002	Nov 5, 2004	7,320,802
Abbvie	TRICOR	fenofibrate	TABLET;ORAL	021203-003	Sep 4, 2001	7,041,319
Abbvie	TRICOR	fenofibrate	TABLET;ORAL	021656-001	Nov 5, 2004	5,145,684
Abbvie	TRICOR	fenofibrate	TABLET;ORAL	021203-001	Sep 4, 2001	7,037,529
Abbvie	TRICOR	fenofibrate	TABLET;ORAL	021203-001	Sep 4, 2001	6,652,881
Abbvie	TRICOR	fenofibrate	TABLET;ORAL	021203-001	Sep 4, 2001	4,895,726

International Patents for TRICOR

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

Country	Patent Number	Title	Estimated Expiration
Greece	3034759
Germany	29825080
Spain	2263714
Portugal	2263652
Norway	329200
Australia	642066
Portugal	499299

TRICOR Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for the Drug: TRICOR

Introduction

TRICOR, a brand name for the drug fenofibrate, is a key player in the global fibrate drugs market. This article delves into the market dynamics, financial trajectory, and strategic maneuvers that have shaped the success and challenges of TRICOR.

Market Definition and Scope

Fibrate drugs, including TRICOR, are primarily used to treat patients with high cholesterol and triglycerides, reducing the risk of atherosclerosis and other cardiac diseases. The global fibrate drugs market is expected to grow at a CAGR of around 5.50% from 2022 to 2029, driven by increasing incidence of cardiac diseases and an expanding elderly population[1].

Drivers of Market Growth

Increased Incidence of Cardiac Diseases

Cardiac disorders are a significant global health issue, accounting for approximately 17.9 million deaths annually, according to the World Health Organization (WHO). This high incidence of heart diseases drives the demand for fibrate drugs like TRICOR[1].

Increase in Elderly Population

The global elderly population is growing, and with it, the prevalence of chronic disorders such as obesity, diabetes, and sleep apnea. These conditions often require the use of fibrate drugs, contributing to market growth[1].

Increasing Demand for Retail Pharmacies

The rise in retail pharmacies, particularly in developed countries, has made fibrate drugs more accessible to patients. This increased accessibility is a key driver of the market[1].

Strategic Maneuvers: Product Hopping

Abbott, the manufacturer of TRICOR, has employed a strategy known as "product hopping" to maintain market dominance and delay generic competition.

Sequential Launch of Reformulations

Abbott has launched several bioequivalent reformulations of fenofibrate, each with slightly different doses, to prevent substitution with generic versions. For example, the transition from Tricor-1 to Tricor-2, and then to Tricor-3, was facilitated through bioequivalence studies rather than clinical trials, allowing Abbott to maintain market share despite the availability of generics[2][4].

Patent Litigation

Abbott has used patent infringement lawsuits to delay the approval of generic versions of TRICOR. This strategy has successfully postponed generic competition, allowing Abbott to continue selling branded reformulations at higher prices[2][4].

Financial Impact of Product Hopping

The practice of product hopping has significant financial implications for the healthcare system.

Annual Costs

An analysis by Matrix Global Advisors found that product hopping for TRICOR and other drugs costs the US healthcare system approximately $748.8 million annually. This figure is part of a broader $4.7 billion annual cost attributed to product hopping for just five brand-name drugs[4].

Pricing Dynamics

The use of product hopping allows brand-name drug companies to maintain higher prices. For instance, the cost of TRICOR can range from $63.16 for a 90-tablet supply of the 48mg formulation to $107.49 for the 145mg formulation, significantly higher than the generic versions which can cost as low as $20.96 for 20 tablets[5].

Role of Pharmacy Benefit Managers (PBMs)

Pharmacy Benefit Managers play a crucial role in the pricing dynamics of prescription drugs, including TRICOR.

Influence on Pricing

PBMs can reduce expenditures on drugs by excluding certain drugs from insurance formularies. However, their ability to do so is limited by consumer inertia and the popularity of certain drugs. In the case of TRICOR, PBMs face challenges in switching patients to generic versions due to the strategic reformulations and patent litigation employed by Abbott[3].

Regional Market Insights

The global fibrate drugs market, including TRICOR, varies by region.

Asia-Pacific

This region is witnessing the highest growth due to an increase in smoking, hypertension, and diabetic populations, as well as the presence of key manufacturers[1].

North America

North America dominates the market due to high incidence rates of smoking, hypertension, and diabetes, along with the presence of major manufacturers like Abbott[1].

Challenges and Restraints

Despite the market growth, there are several challenges facing TRICOR and the broader fibrate drugs market.

Side Effects and Safety Concerns

Fibrate drugs, including TRICOR, can have side effects such as renal issues, which can restrain market growth[1].

Generic Competition

Although delayed by product hopping, generic competition eventually enters the market, posing a significant threat to branded drugs like TRICOR[2].

Key Takeaways

• The global fibrate drugs market, driven by increasing cardiac diseases and an aging population, is expected to grow significantly.
• Abbott's strategic use of product hopping and patent litigation has maintained TRICOR's market dominance.
• Product hopping has substantial financial implications, costing the US healthcare system millions annually.
• PBMs play a critical role in drug pricing dynamics but face limitations in switching patients to generic versions.
• Regional market insights highlight Asia-Pacific and North America as key regions for growth.

FAQs

What is TRICOR used for?

TRICOR (fenofibrate) is used to treat patients with high cholesterol and triglycerides, reducing the risk of atherosclerosis and other cardiac diseases.

How has Abbott maintained market dominance for TRICOR?

Abbott has used a strategy called product hopping, involving the sequential launch of bioequivalent reformulations and patent litigation to delay generic competition.

What are the financial implications of product hopping for TRICOR?

Product hopping for TRICOR costs the US healthcare system approximately $748.8 million annually.

How do Pharmacy Benefit Managers (PBMs) influence the pricing of TRICOR?

PBMs can reduce drug expenditures by excluding certain drugs from insurance formularies, but their ability to do so is limited by consumer inertia and the popularity of certain drugs like TRICOR.

What are the main regions driving the growth of the fibrate drugs market?

Asia-Pacific and North America are the key regions driving the growth of the fibrate drugs market due to high incidence rates of cardiac diseases and the presence of major manufacturers.

Sources

1. Data Bridge Market Research - Global Fibrate Drugs Market – Industry Trends and Forecast to 2029
2. PMC - How Abbott's Fenofibrate Franchise Avoided Generic Competition
3. Harvard Scholar - Explaining Prescription Drug Pricing Dynamics
4. TechTarget - Brand Drug Product Hopping Costs US $4.7B Annually
5. Drugs.com - TriCor Prices, Coupons, Copay Cards & Patient Assistance