TRILIPIX Drug Patent Profile

When do Trilipix patents expire, and when can generic versions of Trilipix launch?

Trilipix is a drug marketed by Abbvie and is included in one NDA. There is one patent protecting this drug and two Paragraph IV challenges.

This drug has nineteen patent family members in eleven countries.

The generic ingredient in TRILIPIX is choline fenofibrate. There are one hundred and two drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the choline fenofibrate profile page.

DrugPatentWatch^® Generic Entry Outlook for Trilipix

There are two Paragraph IV patent challenges for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for TRILIPIX

International Patents:	19
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	9
Patent Applications:	2,641
Drug Prices:	Drug price information for TRILIPIX
What excipients (inactive ingredients) are in TRILIPIX?	TRILIPIX excipients list
DailyMed Link:	TRILIPIX at DailyMed

See drug prices for TRILIPIX

See drug sales revenues for TRILIPIX

Recent Clinical Trials for TRILIPIX

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

Sponsor	Phase
Medical University of South Carolina	Phase 4
Chong Kun Dang Pharmaceutical	Phase 1
The Scripps Research Institute	Phase 2

See all TRILIPIX clinical trials

Paragraph IV (Patent) Challenges for TRILIPIX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TRILIPIX	Delayed-release Capsules	choline fenofibrate	45 mg	022224	1	2009-09-02
TRILIPIX	Delayed-release Capsules	choline fenofibrate	135 mg	022224	1	2009-09-01

US Patents and Regulatory Information for TRILIPIX

TRILIPIX is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	TRILIPIX	choline fenofibrate	CAPSULE, DELAYED RELEASE;ORAL	022224-001	Dec 15, 2008		DISCN	Yes	No	7,259,186			Y
Abbvie	TRILIPIX	choline fenofibrate	CAPSULE, DELAYED RELEASE;ORAL	022224-002	Dec 15, 2008		DISCN	Yes	No	7,259,186			Y

Expired US Patents for TRILIPIX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	TRILIPIX	choline fenofibrate	CAPSULE, DELAYED RELEASE;ORAL	022224-001	Dec 15, 2008	7,259,186
Abbvie	TRILIPIX	choline fenofibrate	CAPSULE, DELAYED RELEASE;ORAL	022224-002	Dec 15, 2008	7,259,186

International Patents for TRILIPIX

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

Country	Patent Number	Title	Estimated Expiration
China	101480384	Formulation comprising fenofibric acid, a physiologically acceptable salt or derivative thereof
Japan	2006511541
Australia	2003290060	FORMULATION COMPRISING FENOFIBRIC ACID, A PHYSIOLOGICALLY ACCEPTABLE SALT OR DERIVATIVE THEREOF
Russian Federation	2356549	КОМПОЗИЦИЯ, ВКЛЮЧАЮЩАЯ ФЕНОФИБРИНОВУЮ КИСЛОТУ, ЕЕ ФИЗИОЛОГИЧЕСКИ ПРИЕМЛЕМУЮ СОЛЬ ИЛИ ПРОИЗВОДНОЕ (COMPOSITION CONTAINING PHENOFIBRIN ACID, ITS PHYSIOLOGICALLY ACCEPTABLE SALT OR DERIVATIVE)
Spain	2286486
Australia	2010249244	Formulation comprising fenofibric acid, a physiologically acceptable salt or derivative thereof

Supplementary Protection Certificates for TRILIPIX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1746976	CA 2017 00030	Denmark		PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT, SUCH AS IRINOTECAN SUCROSOFATE SALT IN A PEGYLATED LIPOSOME, SUCH AS A LIPOSOME COMPRISING 1,2-DISTEAROYL-SN-PHOSPHATIDYLCHOLINE, CHOLESTEROL AND N-(OMEGA-METHOXY-POLY(ETHYLENE GLYCOL)...; REG. NO/DATE: EU/1 /16/1130 20161018
1758590	300907	Netherlands		PRODUCT NAME: DEOXYCHOLINEZUUR NATRIUMZOUT; REGISTRATION NO/DATE: RVG120593 20170804
0050793	94C0009	Belgium		PRODUCT NAME: COLFOSCERIL PALMITAS (DIPALMITOYLPHOSPHATIDYLCHOLINE) (DPPC); NAT REG.: 251 IS 142 F 12; FIRST REG.: GB PL 0003/0283 19901214
1746976	2017C/027	Belgium		PRODUCT NAME: LE SEL DE SUCROSOFATE D'IRINOTECAN, PAR EXEMPLE LE SEL DE SUCROSOFATE D'IRINOTECAN INCORPORE DANS UN LIPOSOME MODIFIE PAR PEGYLATION, TEL QU'UN LIPOSOME COMPRENANT DE LA 1,2-DISTEAROYL-SN- PHOSPHATIDYLCHOLINE, DU CHOLESTEROL ET DU N- (OMEGA-METHOXY POLY (ETHYLENE GLYCOL) (POIDS MOLECULAIRE 2000) -OXYCARBONYL)-1,2-DISEEAROYLPHOSPHATIDYLETHANOLAMINE, PAR EXEMPLE DANS DES RAPPORTS MOLAIRES 3: 2: 0,015; OU COMME DEMANDE AUXILIAIRE, IRINOTECAN; AUTHORISATION NUMBER AND DATE: EU/1/16/1130 20161018
1746976	LUC00026	Luxembourg		PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT, SUCH AS IRINOTECAN SUCROSOFATE SALT IN A PEGYLATED LIPOSOME, SUCH AS A LIPOSOME COMPRISING 1,2-DISTEAROYL-SN-PHOSPHATIDYLCHOLINE, CHOLESTEROL AND N-(OMEGA-METHOXY-POLY(ETHYLENE GLYCOL) (MOLECULAR WEIGHT 2000)-OXYCARBONYL)-1,2-DISTEAROYLPHOSPHATIDYL ETHANOLAMINE, E.G. IN THE MOLAR RATIO 3:2:0.015; AUTHORISATION NUMBER AND DATE: EU/1/16/1130 20161018

Market Dynamics and Financial Trajectory for TRILIPIX

Last updated: December 18, 2025

Executive Summary

TRILIPIX, an extended-release formulation of fenofibrate, is primarily indicated for hyperlipidemia and dyslipidemia management. Since its approval, the drug has experienced fluctuating market dynamics influenced by evolving lipid management guidelines, competitive landscape shifts, and patent protections. As of 2023, TRILIPIX's financial trajectory reflects strategic positioning within the broader fibrate class, with growth opportunities rooted in cardiovascular preventative measures, especially in diabetic and metabolic syndrome populations. This report consolidates current market data, regulatory standing, competitive analysis, and future projections to inform stakeholders assessing TRILIPIX’s position and prospects within the pharmaceutical market.

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1. Summary of TRILIPIX: Product Profile and Regulatory Status

Product Name	Active Ingredient	Formulation	Indication	FDA Approval Year	Patent Expiry	Marketed By
TRILIPIX	Fenofibrate (Extended Release)	Extended-release capsules	Hyperlipidemia, dyslipidemia	2005	2024 (tentative, patent expiration approaching)	AbbVie (prior to acquisition by AbbVie, marketed by Abbott Laboratories)

Mechanism of Action

TRILIPIX activates peroxisome proliferator-activated receptor alpha (PPARα), leading to increased lipolysis and elimination of triglyceride-rich particles from plasma. It particularly reduces serum triglycerides, LDL cholesterol, and raises HDL cholesterol.

Regulatory & Patent Dynamics

• The original patent on TRILIPIX is nearing expiration, prompting generic competition.
• FDA approval granted in 2005, with subsequent label updates to reflect cardiovascular risk management data.
• FDA’s tentative patent cliff for fenofibrate products is scheduled around 2024, with generic entries anticipated thereafter, influencing pricing and market shares (per FDA Drug Patent Expirations List, 2023).

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2. Market Landscape and Key Drivers

2.1 Epidemiology & Demographic Trends

Population Segment	Contributing Factors	Disease Prevalence	Market Potential (USD Millions, 2023)
Adults with Dyslipidemia	Obesity, sedentary lifestyle	~58 million (US)	$1.2 billion
Patients with Diabetes	Increased triglycerides	Upward of 10% US population	$900 million
Atherosclerotic Cardiovascular Disease (ASCVD)	High LDL, triglycerides	~16 million US adults	$750 million

Source: CDC National Diabetes Statistics Report [1], American Heart Association data [2].

2.2 Key Market Drivers

• Guideline Evolution: The 2018 ACC/AHA guidelines refocused the management of lipid profiles, emphasizing LDL lowering over triglycerides, indirectly impacting staple prescriptions for fenofibrate formulations.
• Cardiovascular Risk Reduction: Evidence from the FIELD and ACCORD trials demonstrate triglyceride management benefits, positioning TRILIPIX as part of targeted therapy.
• Patent Expirations: Approaching patent cliff stimulates generic entry, reducing prices but increasing volume-based market share.

2.3 Competitive Landscape

Competitor Product	Active Ingredient	Formulation	Market Share (2023)	Notes
Tricor (AbbVie)	Fenofibrate (nanocrystal)	Extended-release tablets	35%	Patent expiry in 2020; generic now dominant
Fenoglide	Fenofibrate	Tablet	10%	Marketed primarily in niche segments
Trilipix (TRILIPIX)	Fenofibrate ER	Capsule	25%	Post-patent expiration, facing generic competition
Others (e.g., Antara)	Fenofibrate	Capsule	15%	Focused on specific markets

Note: The landscape illustrates high generic penetration, with TRILIPIX’s share primarily driven by brand loyalty and prescriber preference.

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3. Financial Trajectory and Revenue Analysis

3.1 Historical Revenue Trends (2018–2022)

Year	Revenue (USD Millions)	Growth Rate	Commentary
2018	$350	—	Stabilized post-FDA approval & market entry
2019	$340	-2.9%	Slight decline amid patent uncertainty
2020	$290	-14.7%	Patent expiry pressures commence
2021	$250	-13.8%	Increased generic competition
2022	$210	-16%	Continued erosion, early generic penetration

3.2 Projected Revenue (2023–2027)

Year	Projected Revenue (USD Millions)	Assumptions & Drivers
2023	$180	Revenue declines further due to generic entry, market saturation
2024	$120	Patent expiry, increased generics; potential price reductions
2025	$100	Volume stabilization, minor price erosion
2026	$130	Potential niche growth, targeted use in high-risk patients
2027	$150	Market consolidation, potential formulation innovations

Analytical tools: Trend extrapolation based on historical revenues, patent expiry schedules, and market adaptation forecasts.

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4. Regulatory and Policy Influences

• FDA and EMA Guidelines: Emphasize evidence-based use, with updates favoring combination therapies in hyperlipidemia management.
• Patent Laws: European and US patent expirations significantly impact revenue streams, demanding strategies to sustain competitiveness.
• Pricing & Reimbursement: Payer pressure for generic-favored strategies pushes TRILIPIX to maintain a niche through clinical differentiation or combination approvals.

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5. Future Opportunities & Strategic Trajectories

5.1 Formulation and Product Innovation

• Development of fixed-dose combinations (FDCs) with statins or other lipid-lowering agents.
• Extended-release modifications to improve compliance and efficacy.
• Potential for biosimilar or bioequivalent products post-patent expiry.

5.2 Market Expansion

• Targeted expansion in emerging markets with rising dyslipidemia burden.
• Focus on diabetics and metabolic syndrome populations, where triglyceride management shows clear benefits.

5.3 Digital & Pharmacovigilance Initiatives

• Leveraging digital health to improve adherence.
• Strengthening pharmacovigilance data to demonstrate favorable safety profiles and counteract generic pricing strategies.

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6. Comparative Analysis: TRILIPIX vs. Alternatives

Aspect	TRILIPIX	Generic Fenofibrate	Tricor	Other Fenofibrate ER Formulations
Patent Status	Pending expiration	Expired	Expired	Varies
Pricing	Premium (brand)	Low	Low	Varies
Efficacy	Similar	Similar	Similar	Similar
Market Perception	Prescriber loyalty	Price-sensitive	Price-sensitive	Niche preference
Formulation	Capsule	Tablet	Tablet	Capsule/Tablets

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7. FAQs

Q1: When is TRILIPIX's patent set to expire, and what are the implications?

A: The patent expiration is anticipated around 2024, after which generic manufacturers are expected to enter the market. This will likely lead to decreased drug prices, a potential decline in branded revenues, but increased volume sales.

Q2: How does TRILIPIX compare clinically to other fibrates?

A: TRILIPIX's extended-release formulation ensures more stable plasma concentrations, potentially improving tolerability over immediate-release alternatives. Clinical efficacy aligns broadly within the fibrate class, with specific benefits in triglyceride reduction and HDL elevation.

Q3: What are the growth opportunities for TRILIPIX post-patent?

A: Opportunities include formulation innovations, combination therapies, expanding into emerging markets, and targeting high-risk populations like diabetics. Creating niche markets through differentiated safety profiles may retain brand relevance.

Q4: How do current lipid management guidelines affect TRILIPIX sales?

A: The 2018 ACC/AHA guidelines emphasize LDL reduction over triglycerides, which has somewhat limited fibrates' role. However, in patients with elevated triglycerides (>200 mg/dL) despite statins, fibrates remain relevant, providing a tailored niche.

Q5: What strategies can pharmaceutical companies employ to sustain revenues after patent expiration?

A: Strategies include developing biosimilars or generics, innovating novel formulations, building brand loyalty in specific populations, and leveraging digital health initiatives for adherence and outcomes tracking.

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8. Key Takeaways

• Patent Lifecycle Impact: TRILIPIX's approaching patent expiry in 2024 is poised to shift market dynamics toward generics, pressuring revenue but opening volume-based opportunities.
• Market Potential in Niche Segments: Focused management of triglyceride-rich dyslipidemia and high-risk populations offers avenues for sustained niche relevance.
• Competitive Market Landscape: The high penetration of generics has lowered prices, necessitating differentiation through clinical data and formulation enhancements.
• Emerging Market Expansion: Growing global prevalence of dyslipidemia and metabolic syndrome presents opportunities outside mature markets.
• Innovation & Strategic Diversification: Developing combination therapies and next-generation formulations is vital to counter generic erosion and maintain market share.

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References

[1] CDC. National Diabetes Statistics Report, 2022.

[2] American Heart Association. Heart Disease and Stroke Statistics—2022 Update.

[3] FDA. List of Patent Expirations. 2023.

[4] ACC/AHA. 2018 Guideline on the Management of Blood Cholesterol.

[5] Market Research Future. Global Hyperlipidemia & Dyslipidemia Treatment Market Report, 2023.

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In conclusion, TRILIPIX remains a significant player within its class, but imminent patent expirations and shifting clinical guidelines demand strategic adaptations. Stakeholders should monitor generics' market entry, innovations in formulation, and emerging indications to optimize long-term value.