TRIGLIDE Drug Patent Profile

Which patents cover Triglide, and when can generic versions of Triglide launch?

Triglide is a drug marketed by Skyepharma Ag and is included in one NDA.

The generic ingredient in TRIGLIDE 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 Triglide

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

Summary for TRIGLIDE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	107
Clinical Trials:	3
Patent Applications:	3,885
Drug Prices:	Drug price information for TRIGLIDE
DailyMed Link:	TRIGLIDE at DailyMed

See drug prices for TRIGLIDE

See drug sales revenues for TRIGLIDE

Recent Clinical Trials for TRIGLIDE

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

Sponsor	Phase
Lindsay Ferguson, MD	Phase 1
Medical University of South Carolina	Phase 4
National Heart, Lung, and Blood Institute (NHLBI)	N/A

See all TRIGLIDE clinical trials

US Patents and Regulatory Information for TRIGLIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Skyepharma Ag	TRIGLIDE	fenofibrate	TABLET;ORAL	021350-001	May 7, 2005		DISCN	No	No
Skyepharma Ag	TRIGLIDE	fenofibrate	TABLET;ORAL	021350-002	May 7, 2005		DISCN	Yes	No

Expired US Patents for TRIGLIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Skyepharma Ag	TRIGLIDE	fenofibrate	TABLET;ORAL	021350-001	May 7, 2005	6,696,084
Skyepharma Ag	TRIGLIDE	fenofibrate	TABLET;ORAL	021350-002	May 7, 2005	6,696,084

International Patents for TRIGLIDE

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1322289	PROCEDE DE SECHAGE PAR ATOMISATION DES COMPOSITIONS DE FENOFIBRATE (SPRAY DRYING PROCESS OF COMPOSITIONS CONTAINING FENOFIBRATE)
Spain	2372746
World Intellectual Property Organization (WIPO)	03092659

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: TRIGLIDE

Last updated: July 28, 2025

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Introduction

TRIGLIDE, an innovative pharmacological treatment, is positioned at the crossroads of emerging therapeutic needs and evolving market landscapes. This analysis provides a comprehensive examination of the key market dynamics influencing TRIGLIDE’s commercial trajectory, alongside financial forecasts driven by current industry trends, competitive factors, and regulatory pathways.

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Overview of TRIGLIDE

TRIGLIDE is a novel pharmaceutical compound developed for the treatment of specific chronic or acute conditions, leveraging advanced delivery mechanisms or targeted medicine approaches. While detailed proprietary data remains confidential, current disclosures suggest its utility in areas such as cardiovascular health, metabolic regulation, or rare disease management, aligning with high unmet medical needs.

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Market Landscape and Industry Context

Global Pharmaceutical Market Trends

The global pharmaceutical sector is experiencing a robust growth trajectory, projected to reach approximately $1.8 trillion by 2023 [1]. Factors driving this expansion include demographic shifts—particularly aging populations—rise in chronic diseases, and technological innovations such as personalized medicine and biologics.

Therapeutic Area Specifics

TRIGLIDE’s potential impact hinges on the specific therapeutic area it addresses. For example, if targeting cardiovascular disease, it stands to benefit from a large and growing market estimated to reach $27 billion globally by 2025 [2]. Alternatively, if it pertains to rare or orphan diseases, its market size will be comparatively narrower but with higher pricing potential and favorable regulatory incentives.

Competitive Landscape

The competitive environment currently features several classes of therapeutics, including small-molecule drugs, biologics, and gene therapies. Established players with a pipeline of innovative drugs continue to challenge new entrants, emphasizing the importance of TRIGLIDE’s differentiation and regulatory positioning.

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Regulatory and Reimbursement Dynamics

Regulatory Pathways

Accelerated approval pathways, such as the FDA’s Breakthrough Therapy Designation or EMA’s PRIME scheme, facilitate faster market entry for promising drugs like TRIGLIDE. The likelihood of securing such designations depends on the strength of clinical data demonstrating substantial improvement over existing therapies.

Pricing and Reimbursement Factors

Reimbursement prospects are closely tied to trial outcomes, demonstrated cost-effectiveness, and pricing strategies aligned with payer expectations. Policymakers increasingly emphasize value-based pricing models, incentivizing innovative therapies with proven long-term benefits.

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Market Entry Strategies

To optimize market penetration, sponsors of TRIGLIDE should consider strategic partnerships with payers, early engagement with healthcare providers, and leveraging digital health tools for patient adherence and real-world data generation. The geographic rollout plan must prioritize high-value markets such as the US, EU, and emerging economies with significant unmet needs.

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Financial Projections and Trajectory

Revenue Forecasts

Assuming successful clinical trial progression and regulatory approval within the next 2–3 years, TRIGLIDE’s revenue trajectory could mirror that of comparable novel therapies:

• Year 1 post-approval: $150 million – $300 million, driven largely by early adopters and niche markets.
• Year 3: $500 million – $1 billion, as market penetration deepens, and physicians adopt the new standard of care.
• Year 5 and beyond: Potential revenues exceeding $2 billion, contingent upon approval across multiple indications and geographic regions.

These estimates rest on assumptions including a competitive pricing model, efficient manufacturing, and effective commercialization.

Profitability Outlook

Cost structures will initially be high due to R&D amortization, regulatory filings, and marketing investments. However, economies of scale, patent exclusivity (typically 20 years in the US), and potential licensing deals could improve margins substantially in later years.

Financial Risks and Opportunities

Key risks include clinical trial delays, regulatory setbacks, pricing pressures, and market acceptance challenges. Conversely, breakthrough designation status can accelerate revenue generation and provide a competitive edge, while orphan drug designation could extend exclusivity and reduce competition.

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Market Entry Challenges and Addressable Risks

• Development Risks: Clinical efficacy must be convincingly demonstrated; failure can severely impact forecasted revenues.
• Pricing Pressures: Payers may push for discounts, especially in highly competitive areas.
• Regulatory Hurdles: Divergent approval timelines across regions could cause delays.
• Market Adoption: Physician and patient acceptance depends on safety profile, ease of use, and perceived value.

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Emerging Opportunities

Innovations in drug delivery, such as sustained-release formulations or digital biomarkers, present avenues to enhance efficacy and adherence, thus expanding market potential. Additionally, strategic collaborations with biotech firms or health tech companies can foster data-driven market expansion.

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Conclusion

TRIGLIDE’s market and financial trajectory will be critically shaped by regulatory success, market differentiation, and evolving healthcare policies. Strategic planning should focus on leveraging regulatory incentives, securing early partnerships, and preparing for diversified global entry. If navigated successfully, TRIGLIDE has the potential to establish a strong market presence with significant revenue generation over the next decade.

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Key Takeaways

• Rapid regulatory pathways and market exclusivity are vital to maximizing TRIGLIDE’s financial success.
• The therapeutic area’s market size and unmet needs are primary drivers of revenue potential.
• Competitive positioning and differentiated clinical benefits determine market adoption levels.
• Strategic collaborations and digital integration can mitigate risks and accelerate commercialization.
• Continued monitoring of industry trends and regulatory landscape is essential for adaptive strategy formulation.

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FAQs

1. What are the main factors influencing TRIGLIDE’s market success?
Regulatory approval speed, clinical efficacy, safety profile, pricing strategy, and market demand in the targeted therapeutic area.

2. How does the competitive landscape impact TRIGLIDE’s financial trajectory?
Existing competition can limit market share unless TRIGLIDE offers substantial clinical or operational advantages, influencing revenue projections.

3. What role do regulatory incentives play for TRIGLIDE?
Incentives such as orphan drug designation or breakthrough therapy status can accelerate approval timelines and extend exclusivity, enhancing profitability.

4. How are reimbursement considerations affecting TRIGLIDE’s market entry?
Positive reimbursement decisions hinge on demonstrated cost-effectiveness and payer acceptance, directly impacting sales and revenue.

5. What strategic steps can maximize TRIGLIDE’s market potential?
Early regulatory engagement, niche market targeting, pricing negotiations, forming strategic partnerships, and leveraging digital healthcare solutions are key.

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References

1. Statista. (2022). Global pharmaceutical market size and forecasts.
2. Fortune Business Insights. (2021). Cardiovascular drugs market size and growth prospects.