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, Endo Operations, Impax Labs Inc, Macleods Pharms Ltd, Micro Labs, Norvium Bioscience, 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. Ten 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:	10
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	8
Patent Applications:	2,320
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
Aurobindo Pharma Ltd	FENOFIBRIC ACID	choline fenofibrate	CAPSULE, DELAYED RELEASE;ORAL	212598-002	Jul 25, 2019	AB	RX	No	No
Micro Labs	FENOFIBRIC ACID	choline fenofibrate	CAPSULE, DELAYED RELEASE;ORAL	213450-001	Jun 16, 2020	AB	RX	No	No
Actavis Elizabeth	FENOFIBRIC ACID	choline fenofibrate	CAPSULE, DELAYED RELEASE;ORAL	200920-002	Oct 7, 2015	AB	RX	No	No
Rising	FENOFIBRIC ACID	choline fenofibrate	CAPSULE, DELAYED RELEASE;ORAL	211626-001	Jul 18, 2019	AB	RX	No	No
Macleods Pharms Ltd	FENOFIBRIC ACID	choline fenofibrate	CAPSULE, DELAYED RELEASE;ORAL	207796-002	Feb 8, 2024		DISCN	No	No
Alembic	FENOFIBRIC ACID	choline fenofibrate	CAPSULE, DELAYED RELEASE;ORAL	208705-001	May 12, 2017	AB	RX	No	No
Impax Labs Inc	FENOFIBRIC ACID	choline fenofibrate	CAPSULE, DELAYED RELEASE;ORAL	200264-001	Sep 7, 2016	AB	RX	No	No

International Patents for choline fenofibrate

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
Russian Federation	2008149770	КОМПОЗИЦИЯ, ВКЛЮЧАЮЩАЯ ФЕНОФИБРИНОВУЮ КИСЛОТУ ИЛИ ЕЕ ФИЗИОЛОГИЧЕСКИ ПРИЕМЛЕМУЮ СОЛЬ, И КАПСУЛА, ВКЛЮЧАЮЩАЯ КОМПОЗИЦИЮ

Supplementary Protection Certificates for choline fenofibrate

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

Choline fenofibrate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Choline Fenofibrate

Introduction to Choline Fenofibrate

Choline fenofibrate is a medication used to manage lipid and cholesterol levels in the blood, particularly for patients with mixed dyslipidemia. It is a form of fenofibrate, a fibrate drug, which is known for its efficacy in reducing triglycerides and increasing high-density lipoprotein (HDL) cholesterol.

Market Size and Growth Projections

The market for choline fenofibrate is poised for significant growth over the forecast period of 2023 to 2031. According to recent market research, the choline fenofibrate reagent sales market is expected to exhibit strong growth rates, driven by increasing demand for effective lipid management therapies[1][4].

• Global Market Size: The global choline fenofibrate reagent market size is anticipated to grow substantially, with projections indicating a notable increase in revenue from 2023 to 2031.
• Compound Annual Growth Rate (CAGR): The market is expected to grow at a CAGR that reflects the rising need for lipid-lowering therapies, particularly in regions with high prevalence of cardiovascular diseases[4].

Market Segmentation

The market for choline fenofibrate is segmented based on several key factors:

• Type: The market is segmented into various forms such as tablets, capsules, injections, and others. The tablet form, particularly the delayed-release formulation, has shown significant efficacy and safety profiles[1][2].
• Application: The primary applications include hospitals, clinics, and other healthcare settings. Hospital pharmacies are expected to command a significant share of the market due to the high volume of prescriptions and treatments managed within these settings[1][3].
• Geographical Regions: The market is analyzed across regions such as North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. North America and Europe are expected to be major contributors to the market growth due to the high prevalence of cardiovascular diseases and the presence of large-scale production facilities[1][3].

Drivers of Market Growth

Several factors are driving the growth of the choline fenofibrate market:

• Increasing Prevalence of Cardiovascular Diseases: Cardiovascular diseases remain a leading cause of death globally, with approximately 523 million people suffering from these conditions. This has created a vast demand for lipid-lowering therapies like choline fenofibrate[3].
• Efficacy and Safety: Clinical trials have demonstrated that choline fenofibrate is as safe and effective as other forms of fenofibrate, such as micronized fenofibrate, in reducing triglycerides and increasing HDL cholesterol levels[2].
• Government Initiatives and Guidelines: National health programs and guidelines, such as those set by the National Cholesterol Education Program, emphasize the importance of lipid management, further driving the demand for choline fenofibrate[3].

Market Restraints and Challenges

Despite the positive growth trajectory, there are several challenges that the market faces:

• Raw Material Fluctuations: Fluctuations in the prices of raw materials used in the production of choline fenofibrate can impact market growth. Quality management and consistency in raw material supply are crucial for maintaining market stability[4].
• Competition from Other Lipid-Lowering Therapies: The market for lipid-lowering drugs is competitive, with various other therapies available. Choline fenofibrate must compete with other fibrate drugs, statins, and emerging therapies to maintain its market share[3].

Financial Trajectory

The financial outlook for the choline fenofibrate market is promising:

• Revenue Projections: The global fibrate drugs market, which includes choline fenofibrate, is expected to reach nearly US$ 4 billion by 2029, growing at a CAGR of 5% during the forecast period[3].
• Market Share: The fenofibrate segment, which includes choline fenofibrate, is expected to command a significant market share due to its efficacy and widespread use in managing lipid profiles[3].

Key Players and Market Strategies

Several key players are active in the choline fenofibrate market, including:

• Intas Pharmaceuticals Limited: Known for funding clinical trials and promoting choline fenofibrate, especially in regions like India[2].
• Santa Cruz Biotechnology and LGC: These companies are focusing on strengthening their product portfolios and expanding their business in the global market[4].

These companies are employing various strategies such as product diversification, geographical expansion, and strategic partnerships to maintain and grow their market share.

Regional Analysis

The market for choline fenofibrate varies significantly across different regions:

• North America and Europe: These regions are expected to dominate the market due to the high prevalence of cardiovascular diseases and the presence of well-established healthcare systems[1][3].
• Asia-Pacific: This region is also expected to see significant growth due to increasing healthcare expenditure and a rising awareness of lipid management therapies[1].

Consumer Behavior and Healthcare Trends

Consumer behavior and healthcare trends play a crucial role in shaping the market for choline fenofibrate:

• Increased Awareness: Growing awareness about the importance of lipid management and the risks associated with cardiovascular diseases is driving consumer demand for effective therapies like choline fenofibrate.
• E-prescribing and Online Pharmacies: The rise of e-prescribing and online pharmacies is making it easier for patients to access lipid-lowering medications, further boosting the market[3].

Technological and Regulatory Trends

Technological advancements and regulatory changes are also influencing the market:

• Clinical Trials and Regulatory Approvals: Ongoing clinical trials and regulatory approvals are crucial for the continued growth of the choline fenofibrate market. Positive outcomes from these trials can enhance the drug's reputation and expand its use[2].
• Quality Management and Standards: Adherence to quality management standards is essential for maintaining the integrity and efficacy of choline fenofibrate products. This includes ensuring the purity and consistency of the drug[4].

Key Takeaways

• The choline fenofibrate market is expected to grow significantly from 2023 to 2031, driven by increasing demand for lipid-lowering therapies.
• The market is segmented by type, application, and geographical region, with North America and Europe expected to be major contributors.
• Key drivers include the efficacy and safety of choline fenofibrate, increasing prevalence of cardiovascular diseases, and government health initiatives.
• Challenges such as raw material fluctuations and competition from other therapies need to be addressed.
• The financial trajectory is promising, with revenue projections indicating a substantial increase by 2029.

FAQs

Q: What is the expected CAGR for the choline fenofibrate market from 2023 to 2031? A: The exact CAGR is not specified in the sources, but the market is expected to grow significantly during this period[1][4].

Q: How does choline fenofibrate compare to micronized fenofibrate in terms of efficacy and safety? A: Choline fenofibrate is as safe and effective as micronized fenofibrate in reducing triglycerides and increasing HDL cholesterol levels, according to clinical trials[2].

Q: Which regions are expected to dominate the choline fenofibrate market? A: North America and Europe are expected to dominate the market due to the high prevalence of cardiovascular diseases and well-established healthcare systems[1][3].

Q: What are the primary applications of choline fenofibrate? A: The primary applications include hospitals, clinics, and other healthcare settings, with hospital pharmacies commanding a significant share[1][3].

Q: How do fluctuations in raw material prices impact the choline fenofibrate market? A: Fluctuations in raw material prices can impact market growth by affecting the production costs and consistency of the drug[4].

Cited Sources

1. Market Research Intellect: "Choline Fenofibrate Reagent Sales Market Size, Scope And Forecast 2023-2031"[1]
2. Indian Journal of Endocrinology and Metabolism: "Comparison of efficacy and safety of choline fenofibrate delayed release 135 mg and micronized fenofibrate 160 mg in Indian patients with mixed dyslipidemia"[2]
3. Maximize Market Research: "Fibrate Drugs Market: Global Industry Analysis and Forecast (2023-2029)"[3]
4. Cognitive Market Research: "Choline Fenofibrate Reagent Market Report 2024 (Global Edition)"[4]