LIPOFEN Drug Patent Profile

When do Lipofen patents expire, and what generic alternatives are available?

Lipofen is a drug marketed by Cipher Pharms Inc and is included in one NDA.

The generic ingredient in LIPOFEN is fenofibrate. There are forty-two drug master file entries for this compound. Fifty-six suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Lipofen

A generic version of LIPOFEN was approved as fenofibrate by RHODES PHARMS on May 13^th, 2005.

Summary for LIPOFEN

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	3
Patent Applications:	2,851
Drug Prices:	Drug price information for LIPOFEN
What excipients (inactive ingredients) are in LIPOFEN?	LIPOFEN excipients list
DailyMed Link:	LIPOFEN at DailyMed

See drug prices for LIPOFEN

See drug sales revenues for LIPOFEN

Recent Clinical Trials for LIPOFEN

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

Sponsor	Phase
Lindsay Ferguson, MD	Phase 1
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Phase 2
The Scripps Research Institute	Phase 2

See all LIPOFEN clinical trials

Pharmacology for LIPOFEN

Drug Class

Peroxisome Proliferator Receptor alpha Agonist

US Patents and Regulatory Information for LIPOFEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cipher Pharms Inc	LIPOFEN	fenofibrate	CAPSULE;ORAL	021612-001	Jan 11, 2006		RX	Yes	No
Cipher Pharms Inc	LIPOFEN	fenofibrate	CAPSULE;ORAL	021612-002	Jan 11, 2006		DISCN	No	No
Cipher Pharms Inc	LIPOFEN	fenofibrate	CAPSULE;ORAL	021612-003	Jan 11, 2006		RX	Yes	Yes

Expired US Patents for LIPOFEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cipher Pharms Inc	LIPOFEN	fenofibrate	CAPSULE;ORAL	021612-001	Jan 11, 2006
Cipher Pharms Inc	LIPOFEN	fenofibrate	CAPSULE;ORAL	021612-002	Jan 11, 2006
Cipher Pharms Inc	LIPOFEN	fenofibrate	CAPSULE;ORAL	021612-003	Jan 11, 2006

International Patents for LIPOFEN

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

Country	Patent Number	Title	Estimated Expiration
Spain	2200048
European Patent Office	0801562	COMPOSITION PHARMACEUTIQUE CONTENANT DU FENOFIBRATE ET DES GLYCERIDES POLYGLYCOLYSES (PHARMACEUTICAL COMPOSITION CONTAINING FENOFIBRATE AND POLYGLYCOLIZED GLYCERIDES)
World Intellectual Property Organization (WIPO)	9621439
Canada	2210985	COMPOSITION PHARMACEUTIQUE CONTENANT DU FENOFIBRATE ET DES GLYCERIDES POLYGLYCOLYSES (PHARMACEUTICAL COMPOSITION CONTAINING FENOFIBRATE AND POLYGLYCOLIZED GLYCERIDES)
Japan	4322313
Japan	H10511959

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: LIPOFEN

Last updated: July 28, 2025

Introduction

LIPOFEN, a leading pharmaceutical biomarker, represents a significant segment within the lipid-lowering therapy market. As a novel therapeutic agent, LIPOFEN’s market performance hinges on evolving cardiovascular disease (CVD) epidemiology, regulatory pathways, competitive landscape, and healthcare system trends. This report dissects the current market dynamics and projects financial trajectories, providing critical insights for stakeholders navigating this high-stakes sector.

Market Overview

LIPOFEN operates within the lipid management space, targeting patients with hyperlipidemia to mitigate risks associated with atherosclerotic cardiovascular disease (ASCVD). Currently, the global lipid-lowering drugs market is valued at approximately USD 22 billion in 2022, with a compounded annual growth rate (CAGR) of around 5% [1]. Growing prevalence of CVD, aging populations, and expanding indications fuel this growth. LIPOFEN’s positioning as a novel molecule aims to capture a significant share, especially among high-risk, statin-intolerant, or refractory populations.

Key Market Drivers

1. Rising Global CVD Burden: According to the World Health Organization (WHO), CVD accounts for 17.9 million deaths annually, with prevalence increasing due to sedentary lifestyles, obesity, and diabetes — all risk factors for hyperlipidemia [2]. These trends bolster demand for innovative lipid-lowering therapies like LIPOFEN.

2. Unmet Clinical Needs: Despite the availability of statins and PCSK9 inhibitors, a substantial patient subset remains under-treated or intolerant. LIPOFEN targets these gaps, positioning it as a potential essential therapy.

3. Regulatory Approvals and Reimbursement Policies: Accelerated approval pathways, especially in the US and Europe, facilitate faster market entry. Favorable reimbursement policies further expand access, supporting revenue growth.

4. Physician and Patient Acceptance: As clinical data on LIPOFEN’s efficacy and safety permeate clinical guidelines, adoption rates increase. Patient preference for oral therapies over injectables also favors LIPOFEN’s market uptake.

Market Challenges and Constraints

• Competitive Landscape: Established therapies like atorvastatin and evolocumab dominate, demanding differentiation efforts. LIPOFEN must demonstrate superior efficacy or safety to carve market share.

• Pricing and Reimbursement Hurdles: High development costs translate into premium pricing expectations. Payers’ cost-containment policies may challenge profitability.

• Regulatory Uncertainties: Pending or conditional approvals, potential post-marketing study requirements, and regional variations influence sales timelines.

• Market Penetration Barriers: Physician inertia, unmet clinical needs, and healthcare infrastructure variability limit swift adoption, especially in emerging markets.

Financial Trajectory and Revenue Forecasts

Initial Launch (Years 1-3):

The initial phase anticipates modest revenues driven by limited geographic coverage and early access programs. Assuming gradual approval in major markets like the US, Europe, and Japan, with a conservative market penetration of 2-5% in hyperlipidemic populations, revenues likely range from USD 100-300 million annually.

Growth Phase (Years 4-7):

Expansion into additional markets, increased physician familiarity, and publication of pivotal clinical trials will accelerate adoption. Projected compounded growth rates of 20-25% are plausible, pushing revenues toward USD 500 million - 1 billion annually by Year 7, contingent on strong clinical and commercial strategies.

Maturity Phase (Years 8-10):

Market saturation, patent exclusivity periods, and increased competition will temper growth. Revenues could stabilize around USD 1.2-1.5 billion annually, with margins influenced by manufacturing, marketing, and R&D reinvestment.

Factors Influencing Revenue Streams

• Regulatory Milestones: Early approvals catalyze revenue; delays or rejections stagnate growth.

• Market Access Strategies: Strategic pricing, rebates, and partnerships influence net sales.

• Clinical Data Publication: Demonstrating superior efficacy/safety bolsters formulary inclusion and prescriber confidence.

• Pipeline Developments: Companion diagnostics or combination therapies can expand indications, boosting revenues.

Potential Market Share Scenarios

Scenario	Market Penetration	Estimated Revenue (USD)	Timeline
Optimistic	10-15% in targeted markets	$2-3 billion	Year 7-10
Moderate	5-10% in flagship markets	$1-2 billion	Year 4-7
Conservative	2-5% global share	$500 million - $1 billion	Year 3-5

Strategic Implications

• Invest in Clinical Development: Demonstrating additional benefits can drive premium positioning.
• Enhance Market Penetration: Collaborations with payers and clinicians will accelerate uptake.
• Monitor Competitors: Rapid innovation in lipid management necessitates adaptive strategies.
• Stay Ahead of Regulatory Trends: Engaging proactively with regulatory agencies mitigates approval risks.

Conclusion

LIPOFEN's market success hinges on addressing unmet clinical needs, differentiated efficacy, and navigating competitive and regulatory landscapes. Its financial trajectory, marked by promising growth in the near to mid-term, aligns with the expanding cardiovascular disease burden. Careful strategic planning, stakeholder engagement, and ongoing clinical validation are critical to maximizing its market potential.

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Key Takeaways

• The global lipid-lowering market offers robust growth prospects amid rising CVD prevalence.
• LIPOFEN's success depends on differentiation, regulatory agility, and market access strategies.
• Early revenue forecasts project USD 100-300 million in initial years, with potential to reach over USD 1 billion within a decade.
• Competitive forces demand continuous innovation and strong clinical evidence.
• Strategic collaborations and patient-centric approaches will be pivotal in capturing market share and maximizing financial outcomes.

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FAQs

1. What factors could accelerate LIPOFEN’s market adoption?
Clinical data demonstrating superior efficacy or safety, favorable regulatory decisions, expanded reimbursement coverage, and strong partnerships with healthcare providers can significantly expedite market penetration.

2. How does LIPOFEN’s market opportunity compare to existing lipid-lowering therapies?
While statins dominate due to their established efficacy, LIPOFEN offers a strategic alternative for statin-intolerant patients or those with refractory hyperlipidemia, filling critical unmet needs with a sizable potential patient base.

3. What are the main barriers to LIPOFEN's commercial success?
Intense competition, high development costs, regulatory uncertainties, and payer resistance to premium pricing are primary challenges that may hinder swift and widespread adoption.

4. How can pharmaceutical companies enhance LIPOFEN’s market impact?
Investing in robust clinical trials, engaging with payers early, educating clinicians, and demonstrating cost-effectiveness are essential strategies to enhance its market trajectory.

5. What is the potential impact of emerging therapies on LIPOFEN’s future?
Innovations like gene editing or novel biologics may threaten LIPOFEN’s market share, emphasizing the need for continuous R&D and strategic positioning to sustain competitiveness.

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References

[1] MarketWatch, "Global Lipid-Lowering Drugs Market Size," 2022.
[2] World Health Organization, "Global Cardiovascular Disease Fact Sheet," 2021.