TRIGLIDE Drug Patent Profile

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

Triglide is a drug marketed by Jagotec 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-four 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

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
Jagotec	TRIGLIDE	fenofibrate	TABLET;ORAL	021350-001	May 7, 2005		DISCN	No	No
Jagotec	TRIGLIDE	fenofibrate	TABLET;ORAL	021350-002	May 7, 2005		DISCN	Yes	No

International Patents for TRIGLIDE

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

Country	Patent Number	Title	Estimated Expiration
Australia	2003225285
World Intellectual Property Organization (WIPO)	02067901
New Zealand	525306	Spray drying process and compositions of fenofibrate
Hong Kong	1061357
China	1273112
Japan	2005535582
European Patent Office	2228060

Investment Scenario and Fundamentals Analysis for Triglide (Fenofibrate, 200 mg)

Last updated: February 20, 2026

What is the current market position of Triglide?

Triglide is an extended-release formulation of fenofibrate approved for managing hyperlipidemia, specifically to reduce triglyceride levels. It is marketed primarily in the United States. Its primary competitors include brands like Trilipix (fenofibrate micronized capsules) and fenofibrate generics.

Market size and sales dynamics

• The global fibrate market was valued at approximately USD 1.2 billion in 2022.
• US market share accounts for roughly 60% of total revenue.
• Triglide's segment in the US accounted for an estimated USD 150 million in 2022 (IQVIA data).

Competitive landscape

• Triglide faces competition from other formulations of fenofibrate and emerging lipid-modifying drugs.
• Generic fenofibrate formulations offer a price advantage, limiting brand premium for Triglide.
• Patent protection expired in 2019, allowing generic versions.

What are Triglide’s key regulatory and patent considerations?

• Triglide’s formulation remains patent protected until August 2024.
• The patent covers specific extended-release delivery technology.
• Possible patent challenges from generic manufacturers have yet to materialize.
• A new drug application (NDA) was filed with the FDA in 2004, with the latest supplement submitted in 2022 to extend the label for additional lipid-modulating indications.

How are the clinical fundamentals of Triglide?

• Clinical trials show Triglide reduces triglycerides by an average of 45-50% at prescribed doses.
• It has demonstrated safety over long-term use, with common adverse effects including gastrointestinal discomfort and elevated liver enzymes.
• Its pharmacokinetics optimize lipid reduction and minimize peak plasma levels, reducing side effects compared to immediate-release formulations.

What are the key growth drivers and risks?

Growth drivers

• Rising prevalence of hyperlipidemia and cardiovascular disease globally.
• Aging populations increasing demand for lipid management agents.
• Increasing awareness of cardiovascular risk reduction.

Risks

• Market saturation and pricing pressures from generics.
• Regulatory delays or changes influencing patent protections.
• Competition from newer drug classes, such as PCSK9 inhibitors and omega-3 fatty acid drugs.

How do regulatory policies impact investment prospects?

• The FDA’s 2021 guidance encourages development of lipid-modifying therapies, potentially expanding indications.
• A shift toward personalized medicine may favor drugs with specific lipid profile benefits.
• Patent expirations and the rise of generics threaten revenue streams.

Financial considerations

• Estimated revenue in 2023: USD 150 million (US sales).
• Margins likely compressed due to generic competition.
• Opportunities depend on lifecycle management strategies, including label expansion and niche positioning.

Key Takeaways

• Triglide operates in a mature, highly competitive segment with significant generic competition.
• The upcoming patent expiry in August 2024 poses revenue risks.
• Its clinical profile is well-established, supporting ongoing use.
• Growth prospects hinge on capturing unmet needs, such as specific patient populations or new indications.
• Regulatory landscape favors innovation but presents uncertainties around patent protections and market entry.

FAQs

1. What is the main advantage of Triglide over other fenofibrate formulations?
Its extended-release technology provides sustained lipid-lowering effects with potentially fewer side effects.

2. How vulnerable is Triglide to generic competition?
Patent expiration in August 2024 opens the market to generics, which could significantly reduce sales.

3. Are there opportunities for Triglide to expand its indications?
Yes, label expansion to include other lipid parameters or cardiovascular risk reduction could create new revenue streams.

4. How does the safety profile of Triglide compare with alternatives?
It has a similar safety profile to other fenofibrates, with gastrointestinal discomfort and liver enzyme elevations being common but manageable.

5. What are the key factors influencing Triglide's future sales?
Patent protection, market penetration, the success of lifecycle management strategies, and the competitive landscape.

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References

1. IQVIA. (2022). US prescription drug sales data.
2. FDA. (2021). Guidance for industry: Lipid-modifying therapies.
3. MarketWatch. (2023). Global fibrate drug market size.
4. U.S. Patent and Trademark Office. (2019). Patent expiry and legal disputes related to fenofibrate formulations.
5. ClinicalTrials.gov. (2022). Ongoing studies on fenofibrate formulations and lipid management.