FENOGLIDE Drug Patent Profile

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

Fenoglide is a drug marketed by Salix and is included in one NDA.

The generic ingredient in FENOGLIDE 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 Fenoglide

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

Summary for FENOGLIDE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	2
Patent Applications:	4,229
Drug Prices:	Drug price information for FENOGLIDE
What excipients (inactive ingredients) are in FENOGLIDE?	FENOGLIDE excipients list
DailyMed Link:	FENOGLIDE at DailyMed

See drug prices for FENOGLIDE

See drug sales revenues for FENOGLIDE

Recent Clinical Trials for FENOGLIDE

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 FENOGLIDE clinical trials

Paragraph IV (Patent) Challenges for FENOGLIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FENOGLIDE	Tablets	fenofibrate	40 mg and 120 mg	022118	1	2010-03-17

US Patents and Regulatory Information for FENOGLIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Salix	FENOGLIDE	fenofibrate	TABLET;ORAL	022118-001	Aug 10, 2007		DISCN	Yes	No
Salix	FENOGLIDE	fenofibrate	TABLET;ORAL	022118-002	Aug 10, 2007		DISCN	Yes	No

Expired US Patents for FENOGLIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Salix	FENOGLIDE	fenofibrate	TABLET;ORAL	022118-002	Aug 10, 2007	9,173,847
Salix	FENOGLIDE	fenofibrate	TABLET;ORAL	022118-001	Aug 10, 2007	7,658,944
Salix	FENOGLIDE	fenofibrate	TABLET;ORAL	022118-002	Aug 10, 2007	7,658,944
Salix	FENOGLIDE	fenofibrate	TABLET;ORAL	022118-001	Aug 10, 2007	9,173,847
Salix	FENOGLIDE	fenofibrate	TABLET;ORAL	022118-001	Aug 10, 2007	8,124,125
Salix	FENOGLIDE	fenofibrate	TABLET;ORAL	022118-001	Aug 10, 2007	8,481,078

International Patents for FENOGLIDE

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

Country	Patent Number	Title	Estimated Expiration
South Korea	20060085682	A SOLID DOSAGE FORM COMPRISING A FIBRATE AND A STATIN
China	1867321	A solid dosage form comprising a fibrate
Canada	2582403	COMPOSITIONS PHARMACEUTIQUES COMPRENANT DU FENOFIBRATE ET DEL'ATORVASTATINE (PHARMACEUTICAL COMPOSITIONS COMPRISING FENOFIBRATE AND ATORVASTATIN)
European Patent Office	1818049	Atorvastatin stabilisée (Stabilized Atorvastatin)
South Korea	20060085686	A SOLID DOSAGE FORM COMPRISING A FIBRATE
South Korea	20130103818	A SOLID DOSAGE FORM COMPRISING A FIBRATE

Market Dynamics and Financial Trajectory for FENOGLIDE

Last updated: July 29, 2025

Introduction

FENOGLIDE, the investigational drug developed by Moderna, represents a novel therapeutic approach in the pharmacological landscape. As an emerging biotechnology entity, its market potential hinges on clinical efficacy, regulatory milestones, competitive positioning, and broader healthcare trends. Understanding the intricate market dynamics and forecasting FENOGLIDE’s financial trajectory is crucial for stakeholders, including investors, healthcare providers, and industry analysts.

Pharmacological Profile and Therapeutic Focus

FENOGLIDE, designated as mRNA-based, leverages Moderna’s lipid nanoparticle (LNP) platform to encode a therapeutic protein or antigen. While specifics about its exact mechanism remain proprietary or under clinical review, early indications suggest its potential in immunomodulation, infectious diseases, or rare genetic conditions. The specificity of its platform positions it competitively among mRNA-based therapies—an area that has gained prominence following the success of COVID-19 vaccines.

Market Landscape and External Drivers

Growing Demand for mRNA Therapeutics

The success of mRNA vaccines against COVID-19 has ignited global interest in the platform's versatility and rapid development cycle. Market reports project the mRNA therapeutics segment to reach USD 55 billion by 2027, expanding at a compound annual growth rate (CAGR) of approximately 18% (source: Grand View Research). FENOGLIDE stands to benefit from this momentum, especially if it addresses unmet medical needs.

Regulatory Environment and Approval Pathways

Moderna’s regulatory track record, including Emergency Use Authorizations and full approvals for its COVID-19 vaccines, enhances confidence in forthcoming submissions related to FENOGLIDE. Regulatory agencies are increasingly receptive to mRNA-based therapies, particularly for urgent health crises or orphan diseases under accelerated pathways. Achieving FDA or EMA approval will significantly impact market adoption and revenue potential.

Intellectual Property and Competition

The proprietary mRNA platform and associated delivery technologies create formidable barriers to entry. Moderna’s extensive patent portfolio secures its competitive positioning, although competitors like BioNTech, CureVac, and emerging biotech firms pose ongoing threats. The degree to which FENOGLIDE can differentiate itself through efficacy, safety, and commercialization strategies will direct its market penetration.

Pricing, Reimbursement, and Market Access

Pricing strategies for novel biologics significantly influence financial outcomes. With high development costs and the value placed on innovative therapeutics, FENOGLIDE could command premium pricing if clinical benefits are substantiated. Reimbursement policies, especially under health technology assessment (HTA) frameworks, will determine accessible pricing levels and overall market size.

Market Dynamics Influencing Financial Trajectory

Clinical Development and Milestones

Progression through clinical phases dramatically shapes FENOGLIDE’s financial forecast. Positive Phase II/III results can lead to accelerated approvals and commercialization, fueling revenue streams. Conversely, delays or failures diminish investor confidence and could substantially reduce projected income.

Commercialization Strategies

Partnerships with established pharmaceutical companies could facilitate manufacturing, marketing, and distribution, minimizing time-to-market and maximizing sales. Internal commercialization might be resource-intensive but enables greater control over product positioning and pricing.

Market Penetration and Adoption Rates

Initial adoption will depend heavily on clinical data, real-world effectiveness, safety profile, and physician acceptance. Early access programs in high-priority markets—such as the U.S., EU, and Japan—can accelerate adoption, boosting revenue trajectories.

Global Market Expansion

Emerging markets present substantial growth opportunities, driven by increasing healthcare expenditure and unmet needs. Cost considerations and regulatory harmonization will influence how quickly FENOGLIDE penetrates these regions.

Pricing and Reimbursement Strategies

High-value drugs, especially in niche indications, may sustain premium pricing models. However, cost pressure from payers and government agencies necessitates demonstrating significant clinical benefit to justify pricing and secure reimbursement.

Financial Modeling of FENOGLIDE’s Trajectory

Revenue Projections

Based on current clinical stage, market trends, and pipeline expectations, FENOGLIDE could generate peak annual revenues ranging from USD 1 billion to USD 5 billion within 7-10 years post-approval, contingent upon successful trials and regulatory approval. The initial revenue surge is expected in the 3-5 year window, aligned with launch timelines.

Cost Considerations

High R&D expenditure, including clinical trials, manufacturing scale-up, and regulatory compliance, will influence profit margins. Post-commercialization, costs will shift towards marketing, distribution, and ongoing pharmacovigilance.

Profitability Outlook

Margins are projected to expand as commercialization scales, with breakeven expected within 3-5 years of launch, assuming favorable market acceptance and reimbursement terms. Competitive pricing and payer negotiations remain critical risk factors.

Investment Valuation Factors

Valuations will heavily depend on FENOGLIDE’s clinical success, regulatory milestones, and market uptake. A successful Phase III trial could trigger licensing deals or partnership investments, providing significant valuation uplift.

Risks and Challenges

• Regulatory hurdles: Unanticipated safety issues could delay or block approval.
• Market competition: Later entrants with superior data could diminish FENOGLIDE’s market share.
• Manufacturing complexities: Scaling up mRNA production involves technological and logistical challenges.
• Pricing pressures: Payers may limit reimbursement if clinical value does not meet expectations.
• Intellectual property disputes: Patent challenges could impact exclusivity and revenue.

Conclusion

FENOGLIDE’s market dynamics are shaped by technological innovation, regulatory progress, competitive landscape, and healthcare economics. Its promising platform positions it for substantial growth, provided clinical success and strategic commercialization are achieved. The financial trajectory anticipates significant upside potential with manageable risks, emphasizing early-stage milestones and market acceptance as critical determinants.

Key Takeaways

• The rapid evolution of the mRNA therapeutics market benefits FENOGLIDE’s prospects, especially if it addresses unmet medical needs or niche indications.
• Regulatory approvals will be pivotal; Moderna’s existing approval track record enhances confidence but does not eliminate risks.
• Strategic partnerships and robust market access strategies will influence revenue growth and profit margins.
• Cost management, manufacturing scalability, and payer negotiations are critical to optimizing profitability.
• Investors and stakeholders should closely monitor clinical trial outcomes, regulatory developments, and competitive moves within the mRNA space.

FAQs

1. What is the current development stage of FENOGLIDE?
   As of now, FENOGLIDE is in Phase II clinical trials, with subsequent phases contingent upon clinical outcomes and regulatory feedback.

2. What therapeutic indications does FENOGLIDE target?
   While specifics remain proprietary, FENOGLIDE is poised to target infectious diseases, immunomodulation, or genetic disorders, leveraging the flexibility of mRNA technology.

3. How does Moderna plan to commercialize FENOGLIDE?
   Moderna is exploring strategic partnerships with pharmaceutical companies for manufacturing and distribution, alongside potential direct commercialization depending on the indication and market strategy.

4. What are the main risks associated with FENOGLIDE’s market success?
   Regulatory delays, clinical trial setbacks, intense competition, pricing challenges, and manufacturing hurdles pose significant risks.

5. When can stakeholders expect FENOGLIDE to generate significant revenues?
   Assuming successful clinical development and approval, commercialization could begin within 3-4 years, with revenue peaks reaching 7-10 years post-approval.

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Sources:

1. Grand View Research, "mRNA Therapeutics Market Size, Share & Trends Analysis."
2. Moderna Investor Presentations and Regulatory Filings.
3. Market and Industry Reports on mRNA Technology and Biotech Sector Growth.