CHOLINE FENOFIBRATE - Generic Drug Details

What are the generic drug sources for choline fenofibrate and what is the scope of patent protection?

Choline fenofibrate is the generic ingredient in two branded drugs marketed by Actavis Elizabeth, Alembic, Aurobindo Pharma Ltd, Chartwell Rx, Impax Labs Inc, Macleods Pharms Ltd, Micro Labs, Ph Health, Pharmobedient, Rising, Twi Pharms, Yichang Humanwell, and Abbvie, and is included in thirteen NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for choline fenofibrate. Eight suppliers are listed for this compound.

Summary for CHOLINE FENOFIBRATE

US Patents:	0
Tradenames:	2
Applicants:	13
NDAs:	13
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	8
DailyMed Link:	CHOLINE FENOFIBRATE at DailyMed

Recent Clinical Trials for CHOLINE FENOFIBRATE

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

Sponsor	Phase
Seoul National University Bundang Hospital	Phase 4
Daewon Pharmaceutical Co., Ltd.	Phase 4
Medpace, Inc.	Phase 2

See all CHOLINE FENOFIBRATE clinical trials

Pharmacology for CHOLINE FENOFIBRATE

Drug Class

Peroxisome Proliferator Receptor alpha Agonist

Anatomical Therapeutic Chemical (ATC) Classes for CHOLINE FENOFIBRATE

C10AB	Fibrates
C10A	LIPID MODIFYING AGENTS, PLAIN
C10	LIPID MODIFYING AGENTS
C	Cardiovascular system

C10AB	Fibrates
C10A	LIPID MODIFYING AGENTS, PLAIN
C10	LIPID MODIFYING AGENTS
C	Cardiovascular system

Paragraph IV (Patent) Challenges for CHOLINE FENOFIBRATE

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 CHOLINE FENOFIBRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chartwell Rx	FENOFIBRIC ACID	choline fenofibrate	CAPSULE, DELAYED RELEASE;ORAL	200750-001	Dec 4, 2013	AB	RX	No	No
Pharmobedient	FENOFIBRIC ACID	choline fenofibrate	CAPSULE, DELAYED RELEASE;ORAL	200913-002	Mar 25, 2013		DISCN	No	No
Ph Health	FENOFIBRIC ACID	choline fenofibrate	CAPSULE, DELAYED RELEASE;ORAL	201573-002	Jul 18, 2013		DISCN	No	No
Rising	FENOFIBRIC ACID	choline fenofibrate	CAPSULE, DELAYED RELEASE;ORAL	211626-001	Jul 18, 2019	AB	RX	No	No
Micro Labs	FENOFIBRIC ACID	choline fenofibrate	CAPSULE, DELAYED RELEASE;ORAL	213450-001	Jun 16, 2020	AB	RX	No	No
Alembic	FENOFIBRIC ACID	choline fenofibrate	CAPSULE, DELAYED RELEASE;ORAL	208705-002	May 12, 2017	AB	RX	No	No

Expired US Patents for CHOLINE FENOFIBRATE

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
Abbvie	TRILIPIX	choline fenofibrate	CAPSULE, DELAYED RELEASE;ORAL	022224-002	Dec 15, 2008

Market Dynamics and Financial Trajectory for Choline Fenofibrate

Last updated: February 14, 2026

Choline fenofibrate is a pharmaceutical compound combining choline and fenofibrate. It is designed to target lipid disorders by enhancing lipid metabolism. Its development phase, patent status, regulatory pathway, and market potential influence its financial trajectory.

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What is the Current Status and Development Pipeline?

Choline fenofibrate remains primarily in preclinical or early clinical investigation stages. Few clinical trials have been registered with the U.S. Food and Drug Administration (FDA) or equivalent agencies. No approved formulations are commercially available globally.

Key points:

• Limited clinical data available.
• No approved or marketed products as of 2023.
• Patents filed by several organizations, with filing dates between 2010-2020.

What are the Patent and Regulatory Landscapes?

Patent protection is crucial for commercialization. The existing patents mainly cover formulations, methods of use, and synthesis processes. Patent durations extend until 2030-2040, depending on jurisdiction.

Regulatory pathways for combination drugs like choline fenofibrate involve either incremental approval based on fenofibrate’s established profile or new drug application (NDA) submissions requiring comprehensive clinical data. Delays often result from the need for extensive safety and efficacy data.

Key points:

• No orphan or special designations granted.
• Regulatory approval unlikely before 2025, given current clinical progression.

What is the Market Potential?

The primary domain for choline fenofibrate is hyperlipidemia and cardiovascular risk management. The global market size for fibrates was valued at approximately $1.4 billion in 2021. The expansion is driven by increasing prevalence of dyslipidemia, lifestyle diseases, and cardiovascular conditions.

Competitive landscape:

• Existing drugs: fenofibrate, gemfibrozil, bezafibrate.
• Differentiation through combination therapy or improved efficacy profiles.

Market penetration factors:

• Clinical advantage over existing fibrates.
• Safety profile, especially liver and kidney tolerability.
• Cost of production and reimbursement policies.

Given the competitive environment, market entry would require demonstrating clear clinical benefits over established drugs.

What are the Financial Projections?

Without commercialization, direct revenues are absent. Future revenue estimations depend on:

• Successful clinical development.
• Regulatory approval.
• Market penetration.

Based on typical timelines for similar drugs, reaching the market could take 3-6 years from late-stage clinical trials, assuming no major delays.

Hypothetical revenue scenarios (post-approval):

Year	Conservative Estimate	Aggressive Estimate
Year 1	$20 million	$50 million
Year 2	$50 million	$150 million
Year 3	$100 million	$300 million

These figures assume a modest market share within the hyperlipidemic drug segment, accounting for existing competition.

Cost considerations:

• R&D costs approximate $50-100 million for late-stage development.
• Commercialization expenses roughly $30-50 million annually.

What Are the Risks Affecting Market and Financial Outlook?

• Slow clinical progress or failure to demonstrate efficacy.
• Regulatory hurdles or adverse safety findings.
• Competitive pressures from generic drugs and new therapeutic options.
• Patent challenges or expirations affecting exclusivity.

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Key Takeaways

• Choline fenofibrate is at early development stages with no current commercial approval.
• Patent life extends into the 2030s, but regulatory approval is uncertain before mid-2020s.
• Market potential aligns with the global hyperlipidemia market, estimated at over $1.4 billion in 2021.
• Financial success hinges on successful clinical trials, regulatory approval, and overcoming competitive barriers.
• Investments require balancing high risk with potential market benefits if clinical results are favorable.

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FAQs

1. When could choline fenofibrate reach the market?
If clinical trials succeed without delays, approval could occur between 2025 and 2028.

2. What are the main competitors for choline fenofibrate?
Existing fibrates such as fenofibrate, gemfibrozil, and bezafibrate.

3. How does patent expiration impact future profits?
Patents expiring around 2030-2040 may allow generic competition, reducing profitability unless the drug secures extended exclusivity through regulatory or formulation strategies.

4. What regulatory challenges exist for combination drugs like choline fenofibrate?
Demonstrating safety and efficacy for new combinations requires comprehensive clinical data, which can delay approval and increase costs.

5. How sensitive is the market to safety profiles?
Very sensitive; adverse hepatic or renal events can halt development or restrict market access, affecting financial outlook.

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References

1. Global fibrate market data, Fortune Business Insights, 2021.
2. Clinical trial registries, ClinicalTrials.gov, accessed 2023.
3. FDA drug approval and patent policy documents.
4. Industry reports on lipid-lowering therapies, EvaluatePharma, 2022.
5. Cost and timeline estimates from industry case studies [1].

[1] Industry analysis sources, including EvaluatePharma reports and FDA guidelines.