TRIGLIDE Drug Patent Profile

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

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
Raw Ingredient (Bulk) Api Vendors:	107
Clinical Trials:	3
Patent Applications:	4,565
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
Washington University School of Medicine	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
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

Expired US Patents for TRIGLIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Jagotec	TRIGLIDE	fenofibrate	TABLET;ORAL	021350-001	May 7, 2005	6,696,084
Jagotec	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
Austria	357216
Austria	367802
Austria	522211
Australia	2001259099
Australia	2001262945
Australia	2003225285

TRIGLIDE (Prescription Drug) Market Dynamics and Financial Trajectory: Pricing, Access, Volume Drivers, and Patent-Linked Risk

Last updated: May 31, 2026

TRIGLIDE’s market path is determined by (1) payer coverage and step-edit policies, (2) generic and authorized generic entry risk across the triglyceride-indication lifecycle, and (3) the timing of IP exclusivity and patent expirations tied to TRIGLIDE’s active ingredient and dosage form. Without a verifiable FDA/Orange Book record for TRIGLIDE’s exact label, strength, and NDA, a complete, data-backed financial trajectory cannot be produced.

What is TRIGLIDE’s drug identity (active ingredient, NDA, strength, and labeled indications) and why does it drive market dynamics?

TRIGLIDE’s market dynamics depend on which product in the market is being evaluated, because pricing, rebate intensity, and channel mix differ materially by active ingredient class (e.g., lipid-modifying agents), formulation, and the FDA-approved indication set (e.g., hypertriglyceridemia severity and LDL-risk commingling). These factors determine:

• Covered benefit category and utilization management (prior authorization vs. step therapy).
• Competitor set (statins only vs. fibrates vs. omega-3 products vs. newer TG therapies).
• Revenue sensitivity to generic entry and formulary switching.

Market-structure mechanics typically used for TRIGLIDE-like products

• Brand share capture hinges on payer “tiering” and maximum allowable cost programs after competitor price benchmarks.
• Rebate pressure rises when multiple therapeutically equivalent options exist for triglycerides.
• Volume elasticity is limited when prescribers stay aligned to a single TG pathway, but it increases after guideline-linked reclassification or new pathway adoption.

What patents protect TRIGLIDE and how does the patent estate shape its financial trajectory?

TRIGLIDE’s revenue floor is primarily driven by the durability of:

1. composition-of-matter IP,
2. formulation and manufacturing process claims,
3. method-of-use claims tied to the labeled triglyceride regimen,
4. pediatric exclusivity or regulatory exclusivities if applicable.

A defensible financial trajectory needs the patent endgame schedule (expiration dates by claim set, remaining term by formulation, and any listed Orange Book patents tied to the NDA). That requires the specific TRIGLIDE NDA number and Orange Book listing record, which is not provided here.

When does TRIGLIDE lose exclusivity and what is the generic entry risk timeline?

Generic-launch risk is a function of:

• patent expiration (and any statutory term extensions),
• exclusivity blocks (NCE/505(b)(2) exclusivity, pediatric exclusivity),
• ANDA filing patterns and Paragraph IV challenges,
• manufacturing process lockouts and formulation-specific barriers.

Without the TRIGLIDE Orange Book listing set (patent numbers, earliest expiration, and exclusivity codes), the timing profile cannot be stated accurately.

What is the Orange Book status of TRIGLIDE and which patents are listed for the NDA?

Orange Book status determines:

• the effective exclusivity calendar (earliest date generics can attempt),
• whether TRIGLIDE has layered patents covering multiple dosage strengths,
• whether method-of-use or formulation patents dominate the risk.

No Orange Book dataset tied to TRIGLIDE is included, so a correct listing cannot be produced.

How do payer dynamics, rebates, and formulary placement typically evolve for triglyceride-focused brands like TRIGLIDE?

For branded triglyceride therapies, payers usually manage utilization through:

• Prior authorization tied to baseline triglyceride thresholds and secondary causes workup.
• Step therapy requiring trial of a cheaper lipid-modifying option before coverage.
• Formulary tiering and placement under preferred omega-3 or fibrate pathways.

What changes financially

• In early market years, brand share growth tends to be strongest where commercial plans are willing to cover without strict step requirements.
• As therapeutic equivalents accumulate, rebate rates rise to preserve effective net price.
• After generic entry in overlapping triglyceride indications, net pricing compresses quickly, unless the brand retains a niche through dosing convenience, reduced monitoring needs, or superior tolerability in the payer’s evidence framework.

Which competitor set is most likely to pressure TRIGLIDE pricing and market share?

TRIGLIDE’s competitors will depend on:

• whether it is an omega-3 formulation, a fibrate, or another TG pathway agent,
• whether it is indicated for severe hypertriglyceridemia vs. moderate TG elevation,
• dose schedule and safety monitoring footprint.

Competitor sets for TG therapeutics typically include multiple classes, with generics strongest in “older” molecules and newer brands stronger in evidence-supported guideline positioning. The correct list cannot be generated without TRIGLIDE’s active ingredient and label.

What do TRIGLIDE’s channel and mix suggest about margin trajectory?

A brand’s margin trajectory typically follows three phases:

1. Launch and early adoption: higher selling and marketing expense, net price still near list with modest rebate intensity.
2. Coverage tightening: rebate rates climb as formulary restrictions tighten; margin stabilizes if volume holds.
3. Exclusivity endgame: gross-to-net deterioration accelerates; marketing expense may fall while payer pressure increases.

For TRIGLIDE, a quantified trajectory requires the company’s financial filings or audited segment reporting, plus pharmacy claims or estimate datasets tied to TRIGLIDE’s exact NDCs. None are provided.

How does TRIGLIDE compare with competing triglyceride drugs on access, pricing, and evidence?

Comparisons are typically made across:

• labeled indication breadth,
• guideline positioning and outcomes evidence,
• adverse event profile and monitoring burden,
• dosing convenience (frequency and pill burden),
• net price evolution post formulary events.

A correct comparison cannot be produced without TRIGLIDE’s active ingredient, dosage form, and label language.

What patent litigation affects TRIGLIDE (Paragraph IV, settlements, and launch barriers)?

Paragraph IV filings and settlements shape:

• whether generics launch “at risk” pre-settlement,
• design-around threats (new formulation strength, alternative salts),
• timing of authorized generics.

Without TRIGLIDE’s NDA and patent listing set, litigation events cannot be identified or dated.

What generic entry risks exist for TRIGLIDE under ANDA and how likely is at-risk launch?

At-risk launch probability depends on:

• strength and number of Orange Book patents asserted,
• district court stay dynamics (unless resolved),
• FDA tentative approval timeline relative to the effective blocking patent expiration,
• whether TRIGLIDE’s formulation is difficult to reproduce.

No Orange Book or litigation data is available for TRIGLIDE here.

What is TRIGLIDE’s FDA regulatory status (NDA/505(b)(2), approval history, and exclusivity type)?

FDA regulatory status determines:

• exclusivity eligibility (NCE, 505(b)(2), pediatric),
• labeling changes that can extend effective market protection,
• vulnerability to generic substitution if indications are narrowed.

This requires the FDA approval record for TRIGLIDE’s specific NDA.

Commercial trajectory: what financial metrics can be quantified for TRIGLIDE (sales, net price, and market share)?

A quantitative financial trajectory requires at least one of:

• company disclosed sales for TRIGLIDE by year,
• audited segment revenue allocations if TRIGLIDE is within a product group,
• market estimate datasets with TRx and WAC-to-net mapping,
• NDC-level claims data.

Because TRIGLIDE’s identity and FDA code are not verifiable from the input, no correct sales, net revenue, TRx, or market share series can be generated.

Key Takeaways

• TRIGLIDE’s market dynamics and financial trajectory are driven by IP endgame timing, payer utilization management, and generic entry risk.
• A complete, data-backed trajectory requires TRIGLIDE’s exact FDA product identity (active ingredient, NDA, strengths, Orange Book patent list) and financial disclosures. Those inputs are not present, so no accurate patent calendar, litigation timeline, pricing compression schedule, or sales curve can be produced.

FAQs

1. How does an Orange Book patent list change the earliest generic launch date for a brand like TRIGLIDE?
2. What payer rules most commonly limit early growth for triglyceride therapies and how do rebates respond?
3. Which evidence endpoints (TG reduction vs. cardiovascular outcomes) typically drive formulary coverage for TG brands?
4. How do settlement agreements shift at-risk ANDA launch timing near exclusivity expiry?
5. What formulation or manufacturing patents most often block generic substitution for lipid therapies?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026).