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-five 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
The Scripps Research Institute	Phase 2
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	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	022118-001	Aug 10, 2007
Salix	FENOGLIDE	fenofibrate	TABLET;ORAL	022118-002	Aug 10, 2007
Salix	FENOGLIDE	fenofibrate	TABLET;ORAL	022118-002	Aug 10, 2007
Salix	FENOGLIDE	fenofibrate	TABLET;ORAL	022118-001	Aug 10, 2007
Salix	FENOGLIDE	fenofibrate	TABLET;ORAL	022118-002	Aug 10, 2007

International Patents for FENOGLIDE

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

Country	Patent Number	Title	Estimated Expiration
Japan	2007508249
European Patent Office	1818049	Atorvastatin stabilisée (Stabilized Atorvastatin)
World Intellectual Property Organization (WIPO)	2006037347
Canada	2582405	COMPOSITIONS PHARMACEUTIQUES CONTENANT DU FENOFIBRATE ET DE L'ATORVASTATINE (PHARMACEUTICAL COMPOSITIONS COMPRISING FENOFIBRATE AND ATORVASTATIN)
Australia	2004279661	A solid dosage form comprising a fibrate and a statin

Market Dynamics and Financial Trajectory for Fenoglide

Last updated: January 8, 2026

Summary

Fenoglide is a lipid-lowering medication primarily indicated for managing hypercholesterolemia, notably by reducing LDL cholesterol levels. As a fenofibrate-based drug, its market trajectory is influenced by factors such as evolving cardiovascular guidelines, generics competition, and cardiovascular disease prevalence. This analysis explores the key market drivers, financial prospects, competitive landscape, regulatory environment, and future outlook of Fenoglide, offering data-backed insights tailored for industry stakeholders.

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What is Fenoglide and How does it Fit into the Cardiovascular Market?

Fenoglide is a prescription medication formulated to address hyperlipidemia, particularly high LDL cholesterol. Approved by the FDA in 2010, Fenoglide is a branded formulation of fenofibrate, belonging to the fibrate class of drugs. It operates by activating peroxisome proliferator-activated receptor alpha (PPARα), which enhances lipid metabolism.

Parameter	Details
Active Ingredient	Fenofibrate
Formulation	Extended-release tablet
Indications	Hyperlipidemia, hypertriglyceridemia
Market Launch	2010 (FDA approval)

Its position in the cardiovascular health market hinges on the growing focus on lipid management to prevent atherosclerotic cardiovascular disease (ASCVD).

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Market Dynamics Influencing Fenoglide

1. Prevalence of Hyperlipidemia and Cardiovascular Disease

The global burden of cardiovascular disease (CVD) directly impacts Fenoglide's market potential:

Region	CVD Prevalence (2021)	Hyperlipidemia Incidence	Growth Drivers
North America	18 million adults	~30% of adults	Aging population, lifestyle
Europe	55 million with high LDL	Rising awareness	Healthcare policies
Asia-Pacific	Rapid urbanization	Increasing due to diet	Expanding healthcare access

The increasing prevalence supports sustained demand for lipid-lowering therapies.

2. Competitive Landscape

Fenoglide faces competition from generic fenofibrate formulations, other branded drugs like Tricor (AbbVie), Lopid (Bristol-Myers Squibb), and emerging agents such as PCSK9 inhibitors.

Manufacturer	Product	Market Share (Estimated)	Pricing Dynamics
AbbVie	Tricor	~40%	Premium pricing pre-generic expiry
Generic Suppliers	Fenofibrate generics	~50%	Competitive, low-cost
Others	FenOGlide	Niche	Moderate, limited by brand recognition

The entrance of generics post-patent expiration (~2017-2018 for fenofibrate) has significantly compressed revenue streams for branded formulations like Fenoglide.

3. Regulatory and Reimbursement Environment

Policies affecting drug approval, patent life, and reimbursement significantly influence Fenoglide's market potential.

• Patent Expiry: Fenoglide’s patent challenges have led to generic competition.
• Reimbursement: Insurance coverage and formulary inclusion determine market penetration.
• Regulatory Approvals: EMA and FDA approvals guide market access, while ongoing guidelines influence prescribing patterns.

4. Impact of Emerging Therapies

Novel agents, including PCSK9 inhibitors (e.g., alirocumab, evolocumab), provide alternative hyperlipidemia treatments, especially for resistant cases. These biologics, priced higher, challenge the traditional fibrate market, potentially cannibalizing Fenoglide's share where patients switch to newer options.

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Financial Trajectory: Historical and Projected Trends

Historical Revenue Overview

Based on industry estimates, Fenoglide's revenue peaked in the early 2010s but declined sharply after the advent of generics and newer therapies:

Year	Estimated Revenue (USD Million)	Notes
2010	120	Launch year, market entry
2015	90	Post-generic competition begins
2018	35	Significant decline, generic prevalence
2022	15	Minimal market presence

Current Market Position

Fenoglide now operates as a niche product within a highly competitive, commoditized segment. Its revenue is dominated by brand loyalty in certain markets, though most prescriptions likely favor generics or newer agents.

Projected financial trajectory (2023-2030)

Year	Estimated Revenue (USD Million)	Predicted Trends	Key Drivers
2023	10-12	Continued decline	Generic saturation
2025	5-8	Marginal, steady niche	Aging demographics, resistant patients
2030	<5	Likely negligible	Competition, patent expiries

Revenue Drivers and Barriers

Drivers	Barriers
Rising global CVD prevalence	Patent expiries, established generics
Growing awareness of lipid management	Competition from biologics and other drug classes
Potential for combination therapies	Shifts toward novel mechanisms

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Key Market Factors Impacting Fenoglide’s Financial Future

Factor	Impact	Strategic Considerations
Patent landscape	Erosion of exclusivity	Focus on niche indications or combination therapy
Price competition	Pressure on margins	Cost optimization, differentiation
Regulatory changes	Access and reimbursement	Monitor policy shifts and adjust marketing
Clinical guidelines	Prescribing patterns	Emphasize evidence-based benefits

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Comparative Analysis: Fenoglide vs. Industry Alternatives

Parameter	Fenoglide	Generic Fenofibrate	Tricor (AbbVie)	PCSK9 Inhibitors
Formulation	Extended-release	Extended-release	Extended-release	Injectable monoclonal antibody
Pricing (USD)	~$2 per tablet	<$1 per tablet	~$4-6 per tablet	~$14,000 per year
Market Share (Estimated)	Small	Dominant	Moderate	Niche, resistant cases
Route	Oral	Oral	Oral	Subcutaneous injection

The data reflect a shift toward biologics for difficult-to-treat hyperlipidemia, which marginalizes fibrates like Fenoglide.

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Future Outlook and Opportunities

Potential Growth Avenues

• Niche Indications: Exploring roles in specific patient populations with contraindications to statins.
• Combination Formulations: Fixed-dose combinations with statins or ezetimibe.
• Market Expansion: Emerging markets with rising CVD burdens could sustain modest sales.
• Generic Lifecycle Management: Line extensions or reformulations to extend patent life or differentiate.

Risks and Challenges

• Market Saturation: Ubiquity of low-cost generics reduces profitability.
• Regulatory Hurdles: Non-adherence to evolving cardiovascular guidelines.
• Drug Alternatives: Acceptance of novel therapies diminishes fibrate’s relevance.

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Key Takeaways

• Fenoglide’s initial market potential was significant but has waned due to generic competition and emergence of advanced therapeutic options.
• The drug’s revenue is now largely niche-driven, with projected declines continuing through 2030.
• Strategic positioning should focus on niche markets, combination therapies, or geographic expansion, considering the competitive landscape.
• Pharmaceutical companies should monitor regulatory shifts and clinical guidelines that impact hyperlipidemia management.
• Ongoing research possibilities may reopen routes to market differentiation via targeted indications.

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FAQs

1. How does Fenoglide compare to other fenofibrate formulations?
Fenoglide is a branded extended-release fenofibrate formulation, offering a specific release profile. However, post-patent expiration, generic versions dominate the market due to lower prices, making Fenoglide’s revenues negligible compared to generics.

2. What are the reasons for Fenoglide’s declining market share?
The decline stems from patent expiration, widespread availability of low-cost generics, and competition from newer agents such as PCSK9 inhibitors, which serve resistant hyperlipidemia cases more effectively.

3. Can Fenoglide find a niche role in hyperlipidemia treatment?
Potentially, in patients intolerant to statins or with specific lipid profiles, though rigorous clinical evidence and regulatory endorsements are needed to support such use.

4. What regulatory factors influence Fenoglide’s market potential?
Patent expiries, FDA and EMA guidelines, and reimbursement policy changes critically impact market access and profitability.

5. What strategic moves can pharmaceutical companies pursue for Fenoglide?
Focus on niche indications, develop combination therapies, extend formulations, or explore geographic expansion, considering the backdrop of market saturation and evolving therapies.

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References

[1] U.S. Food and Drug Administration. (2010). Fenoglide Prescribing Information.
[2] Global Burden of Disease Study. (2021). Cardiovascular Disease Statistics.
[3] IMS Health. (2019). Market Analysis of Lipid-Lowering Drugs.
[4] BlueCross BlueShield. (2022). Reimbursement Policies for Hyperlipidemia Medications.
[5] MarketWatch. (2022). Trends in Cardiovascular Disease and Lipid Management.

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This detailed analysis offers a comprehensive view of Fenoglide’s market landscape and financial trajectory, equipping industry stakeholders with actionable insights to navigate a complex and evolving environment.