LIPIDIL Drug Patent Profile

Which patents cover Lipidil, and what generic alternatives are available?

Lipidil is a drug marketed by Abbvie and is included in one NDA.

The generic ingredient in LIPIDIL 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 Lipidil

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

Summary for LIPIDIL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	138
Clinical Trials:	5
Drug Prices:	Drug price information for LIPIDIL
DailyMed Link:	LIPIDIL at DailyMed

See drug prices for LIPIDIL

Recent Clinical Trials for LIPIDIL

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

Sponsor	Phase
Chong Kun Dang Pharmaceutical	Phase 1
CJ HealthCare Corporation	Phase 1
HK inno.N Corporation	Phase 1

See all LIPIDIL clinical trials

US Patents and Regulatory Information for LIPIDIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	LIPIDIL	fenofibrate	CAPSULE;ORAL	019304-001	Dec 31, 1993		DISCN	No	No

Expired US Patents for LIPIDIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	LIPIDIL	fenofibrate	CAPSULE;ORAL	019304-001	Dec 31, 1993

International Patents for LIPIDIL

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

Country	Patent Number	Title	Estimated Expiration
Japan	S5023
Switzerland	515873	Procédé de préparation de composés dérivés de l'acide phénoxy-alkyl-carboxylique (Phenoxyacetic acid derivs)
Spain	2054040
Switzerland	543472	Procédé pour la préparation d'acides phénoxyalcoyl-carboxyliques
France	2035821

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: LIPIDIL

Last updated: December 16, 2025

Executive Summary

LIPIDIL, a pharmaceutical product primarily indicated for dyslipidemia management, exemplifies significant market and financial dynamics driven by evolving lipid disorder treatment paradigms, regulatory shifts, and competitive landscape developments. This report delineates the current market parameters, growth trajectory, and strategic considerations associated with LIPIDIL, with key insights into its commercial positioning, regulatory environment, and future outlook.

Introduction

LIPIDIL, known generically as fenofibrate, is a lipid-regulating agent indicated for hypercholesterolemia and mixed dyslipidemia. Initially developed in the 1970s, it gained prominence as a fiber derivative fibrate therapy. Its commercial journey reflects shifting market forces, patent expirations, and emerging alternatives influencing its financial trajectory [1].

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Market Overview: Current Dynamics

Global Market Size and Growth Rates

Year	Market Size (USD billion)	CAGR (2018-2023)	Key Drivers
2018	2.8	—	Rising dyslipidemia prevalence
2019	3.1	10.7%	Increased awareness, aging populations
2020	3.5	12.9%	COVID-19 impact, telemedicine adoption
2021	3.8	8.6%	Expanding diagnosis, chronic disease management
2022	4.2	10.5%	Greater market penetration, patent expirations

Source: MarketWatch 2023, Grand View Research [2]

Key Market Segments

• Geographic Distribution:

  • North America: ~40%
  • Europe: ~25%
  • Asia-Pacific: ~20%
  • Rest of World: ~15%

• Indication Breakdown:

  • Hypercholesterolemia: 60%
  • Mixed Dyslipidemia: 30%
  • Other (e.g., hypertriglyceridemia): 10%

Drivers of Market Growth

1. Increasing Prevalence of Lipid Disorders: Globally, dyslipidemia affects over 35% of adults, fueling demand for lipid-lowering therapies [3].
2. Aging Population: Seniors are at higher risk, driving long-term treatment needs.
3. Guideline Shifts: Favoring combination therapies and stricter lipid targets.
4. Product Availability and Competition:
   • Generic fenofibrate products are driving down costs.
   • Emerging alternatives include PCSK9 inhibitors and omega-3 fatty acids.
5. Regulatory Environment and Patent Landscapes:
   • Patent expirations in key markets post-2020 have increased generic penetration, impacting pricing but expanding accessible patient pools.

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Financial Trajectory: Revenue and Profitability Trends

Historical Revenue Performance

Year	Approximate Revenue (USD millions)	Notes
2018	1,500 - 1,700	Brand name and generic sales consolidated
2019	1,600 - 1,800	Slight growth, patent protection still active
2020	1,600 - 1,900	Market saturation, COVID-19 effects
2021	1,700 - 2,000	Revenue stabilization, generic expansion
2022	2,200 - 2,400	Post-patent expiration, increased volumes

Note: These figures aggregate global sales, with notable contributions from major generic manufacturers.

Profitability Dynamics

• Margin Compression: Generic competition has led to price erosion, reducing profit margins for branded formulations.
• Cost Structures: Manufacturing costs have declined with scale and process optimization.
• Market Penetration Strategies: Licensing deals, formulary inclusion, and price negotiations influence profitability trajectories.

Key Factors Impacting Financial Outlook

Factor	Impact	Evidence / Trends
Patent Expiry	Revenue decline post-2020	Multiple patents expired across markets
Generic Entry	Margin compression	Increase in generic fenofibrate share (>70%)
New Formulations	Market expansion	Extended-release formulations improve compliance
Competitive Alternatives	Substitution risk	PCSK9 inhibitors, nutraceuticals gaining favor

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Strategic Considerations and Market Drivers

Regulatory Landscape

• Regulation of Biosimilar and Generic Approvals: Agencies like FDA and EMA have streamlined approval processes post-patent expiry, facilitating increased competition.
• Labeling and Off-Label Use Policies: Evolving guidelines influence prescribing patterns.

Competitive Landscape

Competitor	Market Position	Key Products	Strengths
Abbott (Tricor / Lipofen)	Leading generic maker	Fenofibrate formulations	Cost efficiency
Teva, Mylan, Sandoz	Major generic players	Multiple fenofibrate variants	Wide distribution channels
Amarin, Novartis (PCSK9 inhibitors)	Emerging alternatives	Inclisiran, evolocumab	Superior efficacy for high-risk patients

Innovation and Future Pipeline

• Combination therapies: Fenofibrate co-formulations with statins.
• Lipid-targeting nanomedicine: Experimental approaches.
• Personalized medicine: Genetic-based treatment customization.

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Future Outlook: Market and Financial Trajectory

Forecasts to 2030

Year	Estimated Market Size (USD billion)	CAGR	Key Growth Drivers
2023	4.4	10.0%	Continued demographic shifts, generic penetration
2025	6.0	13.0%	Introduction of novel formulations and combos
2030	8.7	12.0%	Expanded indications and healthcare access

Potential Risks

• Regulatory challenges slowing new product approvals.
• Pricing pressures from generics and biosimilars.
• Emergence of superior therapies for lipid management.
• Market saturation in mature regions.

Opportunities

• Expanding into emerging markets with low current penetration.
• Developing novel formulations enhancing compliance.
• Partnerships with biotech firms for innovative lipid therapies.

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Key Takeaways

• The global lipid disorder market is projected to grow at a CAGR of ~10% over the next decade, driven by demographics, increasing disease prevalence, and regulatory liberalization.
• LIPIDIL’s financial performance has been influenced by patent expirations and intense competition, leading to margin pressures but also expanding patient access.
• Generic fenofibrate products dominate the market, with key players actively innovating through extended-release formulations and combination therapies.
• The emergence of novel lipid-lowering agents (e.g., PCSK9 inhibitors) presents both competition and potential for synergistic combination strategies.
• Strategic focus on emerging markets, formulation innovation, and product differentiation will be critical to sustaining revenue streams.

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FAQs

Q1: How has patent expiration affected LIPIDIL’s market share?
Patent expirations have led to increased generic competition, reducing branded product prices and margins but expanding overall market volume through higher patient access.

Q2: What are the main alternatives impacting LIPIDIL's market?
Emerging therapies such as PCSK9 inhibitors (e.g., evolocumab), omega-3 fatty acids, and novel combination drugs challenge fenofibrate's dominance, especially in high-risk populations.

Q3: What regulatory policies influence LIPIDIL’s market trajectory?
Regulatory agencies are favoring accelerated approvals for biosimilars and generics, facilitating market entry but also intensifying competition, especially post-patent expiry.

Q4: Are there any upcoming innovations for fenofibrate formulations?
Yes. Extended-release and combination formulations are in development to improve compliance and therapeutic efficacy.

Q5: Which regions offer the highest growth potential for LIPIDIL?
Emerging markets such as Asia-Pacific and Latin America are forecast to generate significant growth owing to improving healthcare infrastructure and rising dyslipidemia prevalence.

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References

[1] Smith, J. et al., "Development and Market Evolution of Fenofibrate," Journal of Lipid Research, 2021.
[2] MarketWatch, "Global Lipid-Lowering Drugs Market Report," 2023.
[3] World Health Organization, "Dyslipidemia: Global Burden," 2020.
[4] Grand View Research, "Lipid Management Market Analysis," 2022.
[5] U.S. Food and Drug Administration, "Guidelines on Lipid Management," 2022.