Choline fenofibrate - Generic Drug Details

What are the generic drug sources for choline fenofibrate and what is the scope of freedom to operate?

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. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Choline fenofibrate has nineteen patent family members in eleven countries.

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

Summary for choline fenofibrate

International Patents:	19
US Patents:	1
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
Essentialis, 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
Micro Labs	FENOFIBRIC ACID	choline fenofibrate	CAPSULE, DELAYED RELEASE;ORAL	213450-001	Jun 16, 2020	AB	RX	No	No
Ph Health	FENOFIBRIC ACID	choline fenofibrate	CAPSULE, DELAYED RELEASE;ORAL	201573-002	Jul 18, 2013		DISCN	No	No
Yichang Humanwell	FENOFIBRIC ACID	choline fenofibrate	CAPSULE, DELAYED RELEASE;ORAL	212562-002	Dec 23, 2020	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

International Patents for choline fenofibrate

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1832285	Formulation comprenant de l'acide fénofibrique ou l'un de ses sels physiologiquement acceptable (Formulation comprising fenofibric acid or a physiologically acceptable salt thereof)
Japan	2006511541
Germany	60313359

Supplementary Protection Certificates for choline fenofibrate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0050793	94C0009	Belgium		PRODUCT NAME: COLFOSCERIL PALMITAS (DIPALMITOYLPHOSPHATIDYLCHOLINE) (DPPC); NAT REG.: 251 IS 142 F 12; FIRST REG.: GB PL 0003/0283 19901214
1758590	300907	Netherlands		PRODUCT NAME: DEOXYCHOLINEZUUR NATRIUMZOUT; REGISTRATION NO/DATE: RVG120593 20170804
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

Market Dynamics and Financial Trajectory for Cholinium Fenofibrate

Last updated: July 27, 2025

Introduction

Cholinium Fenofibrate, a derivative of fenofibrate, emerges as an innovative pharmaceutical agent targeting lipid disorders. With cardiovascular diseases remaining the principal cause of mortality worldwide, drugs that effectively manage hyperlipidemia continue to attract significant investment and development focus. This analysis explores the market landscape and financial trajectory for Cholinium Fenofibrate, examining current trends, competitive positioning, regulatory considerations, and future growth opportunities.

Overview of Cholinium Fenofibrate

Cholinium Fenofibrate is an advanced formulation of fenofibrate, a well-established triglyceride-lowering agent classified as a fibric acid derivative. Its unique chemical structure involves choline linkage, purportedly enhancing pharmacokinetics, bioavailability, and safety profiles. These attributes position Cholinium Fenofibrate as a potential successor or complement to traditional fenofibrate formulations, aiming to optimize efficacy while minimizing adverse effects.

Market Drivers

1. Rising Prevalence of Dyslipidemia and Cardiovascular Diseases

The global burden of dyslipidemia is accelerating, propelled by increasing incidences of obesity, diabetes, and sedentary lifestyles. The World Health Organization reports cardiovascular diseases account for approximately 17.9 million deaths annually, emphasizing the need for effective lipid-modifying agents. Cholinium Fenofibrate could capture market share by offering an improved therapeutic option.

2. Advancements in Drug Delivery and Formulation

Innovations in drug delivery systems bolster the market trajectory of new formulations like Cholinium Fenofibrate. Enhanced bioavailability and reduced side effects augment patient compliance, factors critical for long-term therapy in chronic conditions.

3. Aging Population and Growing Healthcare Expenditure

An aging demographic predisposes to lipid abnormalities. Simultaneously, escalating healthcare expenditures enable a higher willingness among payers to invest in premium pharmaceutical solutions. Cholinium Fenofibrate's potential for better tolerability aligns with these trends.

4. Intensified R&D Activities and Strategic Alliances

Pharmaceutical companies are investing heavily in R&D to develop next-generation lipid modifiers. Partnerships focused on novel formulations or leveraging patent protections for Cholinium Fenofibrate will propel market expansion.

Market Challenges

1. Patent Expiry and Generic Competition

Fenofibrate patents have historically faced expiration, inviting generic competition which exerts downward pressure on prices. The novelty and patentability of Cholinium Fenofibrate are essential to sustain proprietary advantages, yet regulatory hurdles may delay exclusivity.

2. Regulatory Hurdles

Approval processes hinge on demonstrating safety and efficacy, requiring substantial clinical data. For a new chemical entity like Cholinium Fenofibrate, navigating the complex regulatory landscape can delay market entry or increase costs.

3. Market Education and Acceptance

Clinicians and patients accustomed to existing fenofibrate formulations may hesitate to adopt new derivatives without robust clinical evidence. Education and head-to-head trials are critical for adoption.

4. Competition from Alternative Lipid-Lowering Agents

Emerging drugs such as PCSK9 inhibitors and newer statins may limit the growth of fibrates. Cholinium Fenofibrate must demonstrate distinct advantages to carve out its market segment.

Financial Trajectory and Investment Landscape

1. R&D Funding and Strategic Partnerships

Pharmaceutical firms and biotech investors recognize high potential in reformulating established drugs with improved safety profiles. Early-stage investments into Cholinium Fenofibrate focus on preclinical validation, with subsequent funding allocated upon positive clinical data.

2. Clinical Development Phases

The pathway from discovery to market involves rigorous clinical trials. Phase I studies assessing safety, pharmacokinetics, and tolerability are underway or pending for many lipid-modifying products, including derivatives like Cholinium Fenofibrate. Successful completion may trigger licensing agreements and licensing revenue.

3. Market Penetration and Revenue Projections

Assuming successful clinical development and regulatory approval within 3-5 years, Cholinium Fenofibrate could generate substantial revenue opportunities, particularly in North America and Europe, where lipid disorder therapeutics constitute significant market segments. Market penetration will depend on strategic marketing, clinical positioning, and reimbursement policies.

4. Pricing Strategies

Innovative formulations typically command premium pricing during the initial launch phase. However, long-term profitability hinges on balancing pricing with market competitiveness, considering generic erosion post-patent expiry.

5. Competitive Market Environment

The global fibrate market was valued at approximately USD 1.2 billion in 2021 and is projected to expand at a CAGR of 6% through 2030 [1]. Cholinium Fenofibrate, if positioned as a superior product, could capture a portion of this growth, supported by increased demand for safer, more effective lipid management drugs.

Regulatory and Patent Considerations

Securing patent protection remains paramount. Patents covering unique chemical structures, formulations, or delivery mechanisms for Cholinium Fenofibrate can secure exclusivity for 10-20 years. Regulatory filings with agencies such as the FDA and EMA must demonstrate substantial clinical advantage over existing therapies, influencing financial forecasts.

Market Opportunities and Future Outlook

1. Expansion into Emerging Markets

Growing healthcare infrastructure and rising prevalence of cardiovascular risk factors in Asia-Pacific and Latin America position these regions as lucrative markets for Cholinium Fenofibrate. Tailored pricing and distribution strategies can accelerate penetration.

2. Combination Therapies

Developing fixed-dose combinations coupling Cholinium Fenofibrate with statins or other lipid-lowering agents could address unmet needs, expand indications, and improve adherence.

3. Personalized Medicine Approaches

Integrating pharmacogenomics to identify responsive patient populations could optimize therapy outcomes, justify premium pricing, and enhance reimbursement prospects.

4. Lifecycle Management

Secondary indications, such as treating hypertriglyceridemia in diabetic patients, can provide additional revenue streams. Ongoing research into lipid metabolism may uncover new application domains for Cholinium Fenofibrate.

Conclusion

Cholinium Fenofibrate stands at a promising juncture within the lipid-modifying pharmacotherapy landscape. Its success hinges on securing regulatory approval, establishing clinical superiority, and safeguarding intellectual property. While facing challenges from generic competition and alternative therapies, strategic R&D investments, market education, and tailored marketing campaigns can foster sustainable growth. With cardiovascular disease continuing to dominate global health burdens, innovative agents like Cholinium Fenofibrate are poised to derive significant financial benefits, provided execution aligns with evolving healthcare needs.

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Key Takeaways

• Cholinium Fenofibrate offers a promising next-generation lipid-modifier with potential for improved safety and efficacy.
• Market growth is driven by rising dyslipidemia prevalence, aging populations, and advances in drug formulation.
• Success depends on overcoming regulatory hurdles, securing intellectual property, and demonstrating clinical advantages.
• Strategic expansion includes entering emerging markets, developing combination therapies, and personalizing treatment approaches.
• Long-term revenue prospects rely on effective clinical development, competitive pricing, and lifecycle management strategies.

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FAQs

1. How does Cholinium Fenofibrate differ from traditional fenofibrate formulations?
Cholinium Fenofibrate is a derivative with choline linkage, designed to enhance bioavailability, reduce side effects, and improve pharmacokinetic profiles compared to conventional fenofibrate.

2. What are the main regulatory challenges for Cholinium Fenofibrate?
Regulatory agencies require comprehensive clinical data demonstrating safety and efficacy. As a novel derivative, it must also secure patent protection, which influences approval timelines.

3. What are the key market opportunities for Cholinium Fenofibrate?
Significant opportunities exist in aging populations, emerging markets, and through combination therapies. Additionally, its potential in personalized medicine enhances its commercial appeal.

4. How might generic competition impact the financial trajectory of Cholinium Fenofibrate?
Patent expirations could lead to market erosion unless the drug maintains patent protection or gains exclusive approval based on clinical superiority, affecting revenue streams.

5. What strategic steps should pharmaceutical companies take to maximize Cholinium Fenofibrate’s market success?
Prioritize clinical trials to demonstrate benefits, secure robust patent protections, engage healthcare providers through education, and explore expansion into new markets and indications.

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References:

[1] Market Research Future. “Fibrate Market Forecast to 2030,” 2022.