TRILIPIX Drug Patent Profile

When do Trilipix patents expire, and when can generic versions of Trilipix launch?

Trilipix is a drug marketed by Abbvie and is included in one NDA.

The generic ingredient in TRILIPIX is choline fenofibrate. There are one hundred and two drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the choline fenofibrate profile page.

Summary for TRILIPIX

US Patents:	0
Applicants:	1
NDAs:	1

Paragraph IV (Patent) Challenges for TRILIPIX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TRILIPIX	Delayed-release Capsules	choline fenofibrate	45 mg	022224	1	2009-09-02
TRILIPIX	Delayed-release Capsules	choline fenofibrate	135 mg	022224	1	2009-09-01

US Patents and Regulatory Information for TRILIPIX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	TRILIPIX	choline fenofibrate	CAPSULE, DELAYED RELEASE;ORAL	022224-001	Dec 15, 2008		DISCN	Yes	No
Abbvie	TRILIPIX	choline fenofibrate	CAPSULE, DELAYED RELEASE;ORAL	022224-002	Dec 15, 2008		DISCN	Yes	No

International Patents for TRILIPIX

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

Country	Patent Number	Title	Estimated Expiration
Austria	359777
Australia	2003290060	FORMULATION COMPRISING FENOFIBRIC ACID, A PHYSIOLOGICALLY ACCEPTABLE SALT OR DERIVATIVE THEREOF
Australia	2010249244	Formulation comprising fenofibric acid, a physiologically acceptable salt or derivative thereof
Canada	2510261	FORMULATION COMPORTANT DE L'ACIDE FENOFIBRIQUE, UN SEL OU UNDERIVE PHYSIOLOGIQUEMENT ACCEPTABLE DE CET ACIDE (FORMULATION COMPRISING FENOFIBRIC ACID, A PHYSIOLOGICALLY ACCEPTABLE SALT OR DERIVATIVE THEREOF)
China	100473378

Supplementary Protection Certificates for TRILIPIX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1746976	CA 2017 00030	Denmark		PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT, SUCH AS IRINOTECAN SUCROSOFATE SALT IN A PEGYLATED LIPOSOME, SUCH AS A LIPOSOME COMPRISING 1,2-DISTEAROYL-SN-PHOSPHATIDYLCHOLINE, CHOLESTEROL AND N-(OMEGA-METHOXY-POLY(ETHYLENE GLYCOL)...; REG. NO/DATE: EU/1 /16/1130 20161018
1746976	2017C/027	Belgium		PRODUCT NAME: LE SEL DE SUCROSOFATE D'IRINOTECAN, PAR EXEMPLE LE SEL DE SUCROSOFATE D'IRINOTECAN INCORPORE DANS UN LIPOSOME MODIFIE PAR PEGYLATION, TEL QU'UN LIPOSOME COMPRENANT DE LA 1,2-DISTEAROYL-SN- PHOSPHATIDYLCHOLINE, DU CHOLESTEROL ET DU N- (OMEGA-METHOXY POLY (ETHYLENE GLYCOL) (POIDS MOLECULAIRE 2000) -OXYCARBONYL)-1,2-DISEEAROYLPHOSPHATIDYLETHANOLAMINE, PAR EXEMPLE DANS DES RAPPORTS MOLAIRES 3: 2: 0,015; OU COMME DEMANDE AUXILIAIRE, IRINOTECAN; AUTHORISATION NUMBER AND DATE: EU/1/16/1130 20161018
0050793	94C0009	Belgium		PRODUCT NAME: COLFOSCERIL PALMITAS (DIPALMITOYLPHOSPHATIDYLCHOLINE) (DPPC); NAT REG.: 251 IS 142 F 12; FIRST REG.: GB PL 0003/0283 19901214
1758590	300907	Netherlands		PRODUCT NAME: DEOXYCHOLINEZUUR NATRIUMZOUT; REGISTRATION NO/DATE: RVG120593 20170804
1746976	LUC00026	Luxembourg		PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT, SUCH AS IRINOTECAN SUCROSOFATE SALT IN A PEGYLATED LIPOSOME, SUCH AS A LIPOSOME COMPRISING 1,2-DISTEAROYL-SN-PHOSPHATIDYLCHOLINE, CHOLESTEROL AND N-(OMEGA-METHOXY-POLY(ETHYLENE GLYCOL) (MOLECULAR WEIGHT 2000)-OXYCARBONYL)-1,2-DISTEAROYLPHOSPHATIDYL ETHANOLAMINE, E.G. IN THE MOLAR RATIO 3:2:0.015; AUTHORISATION NUMBER AND DATE: EU/1/16/1130 20161018

TRILIPIX (fenofibric acid) Investment Scenario & Patent/Exclusivity Fundamentals

Last updated: July 21, 2026

TRILIPIX (fenofibric acid) is a lipid-modifying, fibric-acid therapy for mixed dyslipidemia and related indications. Investment relevance is primarily driven by (i) the remaining patent and exclusivity landscape for branded TRILIPIX (and any long-tail formulation/process protections), (ii) uptake versus competing fenofibrate products and newer lipid agents, and (iii) price and volume resilience under ongoing generic competition.

Where is TRILIPIX sold and what is the investment “revenue engine” today?

Featured snippet answer: TRILIPIX is an oral fenofibric-acid product targeting dyslipidemia segments that overlap with generics of fenofibric acid/fenofibrate and with broader non-fibric competitors (ezetimibe, PCSK9 inhibitors, and statin-based intensification). Investment underwriting hinges on whether TRILIPIX maintains differentiated formulary access, dosing convenience, and tolerability versus generic fenofibrate/fenofibric acid products.

Commercial model: what moves the P&L

Key commercial sensitivities for a mature lipid franchise like TRILIPIX:

• Formulary positioning and rebates versus generic fenofibrate and generic fenofibric-acid offerings.
• Gross-to-net compression driven by payer contracting and competitor pricing.
• Patient persistence given chronic use and tolerability endpoints (myalgia risk perception, lab monitoring adherence).
• Indication mix across hypertriglyceridemia and mixed dyslipidemia subsegments.

Competitive set map (practical underwriting)

TRILIPIX competes in a crowded lipid market:

• Direct generic substitutes: fenofibrate and fenofibric-acid products.
• Class alternatives: statin intensification, ezetimibe, and in higher-risk populations PCSK9 therapies.
• Therapy behavior: many prescribers start with statins and add-on agents; fibric acids remain most relevant for persistent hypertriglyceridemia and mixed dyslipidemia not controlled by other approaches.

What is the regulatory status of TRILIPIX in the US (Orange Book, FDA approvals, exclusivity)?

Featured snippet answer: TRILIPIX is an FDA-approved prescription drug product, and as a marketed fibric-acid therapy it is subject to Abbreviated New Drug Application (ANDA) competition once relevant exclusivity and listed patents expire. Orange Book status drives the timeline for generic entry risk and any Paragraph IV challenges.

What “status” means for investment timing

For investment work, the relevant Orange Book checkpoints are:

• Listed patents on the active ingredient/product-by-product basis (drug substance and drug product).
• Patent expiration dates tied to generic entry windows.
• Whether the branded product still has unexpired patent listings or exclusivity (3-year, 5-year, pediatric, etc.).

FDA labeling and clinical framing that influences payer coverage

Underwriting also considers how TRILIPIX’s approved labeling narrows or broadens formulary coverage relative to competitors:

• Indication language affects payer criteria and prior authorization frequency.
• Safety monitoring requirements influence adherence and clinic workflow costs.

When does TRILIPIX lose exclusivity and what generic entry risks exist?

Featured snippet answer: TRILIPIX is in the late lifecycle where major generic entry risk is generally tied to the expiration of listed Orange Book patents and any remaining exclusivity. The generic risk profile is usually mature, with ongoing competitive pressure from authorized generics and ANDA products.

How generic entry typically plays out in this class

In fenofibric/fenofibrate categories:

• Generic entry is often “multiple-product” rather than single-point. Even after the first generic launch, additional ANDAs expand market share erosion.
• Switching is payer-driven through formulary lists and pharmacy benefit manager (PBM) step therapy.

Paragraph IV and litigation risk: why it matters even post-launch

Even when the headline expiration has passed, branded companies can still face:

• Additional patent assertions against incremental generic products, packaging, or formulation/process claims.
• Settlement agreements that can include delayed launch terms or carveouts.

What patents protect TRILIPIX and how strong is the patent estate?

Featured snippet answer: TRILIPIX patent protection historically covers multiple layers typical for lipid products: composition of matter for fenofibric acid (and/or specific salts/solvates), drug product/formulation, and sometimes manufacturing processes. The investment conclusion depends on which Orange Book patents remain active and enforceable versus those long expired.

Patent estate structure to model for TRILIPIX

For an investment model, the patent portfolio is evaluated across these buckets:

1. Drug substance composition claims (active ingredient, salt form, polymorph, or related chemical matter).
2. Drug product claims (formulation, granulation, coating, delayed/extended release mechanisms).
3. Method-of-use claims (indication-specific dosing regimens).
4. Manufacturing process claims (steps that differentiate commercial production).

Strength scoring framework (what to underwrite)

A practical scoring system for a branded lipid product:

• Remaining life: time until expiration of the latest relevant Orange Book patent listing.
• Claim defensibility: breadth of independent claims, sensitivity to generic redesign.
• Litigation posture: history of settlements, adverse rulings, or narrow construction trends.
• “Design-around” risk: whether generics can route around using alternative processes or formulation compositions.

What formulations are protected by TRILIPIX and do “product differences” matter for generics?

Featured snippet answer: If TRILIPIX has unexpired drug product/formulation patents, those claims can matter because generics must match the reference listed drug (RLD) and may face additional barriers if formulation is tied to protected manufacturing steps or specific excipient/coating systems.

Why formulation patents can persist even after drug substance expires

Even with fenofibric-acid composition-of-matter protections expired, formulation and process protections can:

• Delay “full” generic substitution if claims are asserted or if settlements require launch timing.
• Affect AB-rating outcomes if the ANDA seeks to use an alternative formulation strategy that triggers patent issues.

How does TRILIPIX compare with competing fenofibrate/fenofibric-acid drugs from an investment standpoint?

Featured snippet answer: TRILIPIX competes in a mature generic-heavy therapeutic category where differentiation is often limited to dosing, patient tolerability, and payer access rather than patent-protected exclusivity.

Underwrite relative value using market structure

For investment scenarios:

• Brand premium capture: whether TRILIPIX holds meaningful price premium versus nearest generic.
• Channel mix: specialty pharmacy vs retail coverage patterns.
• Switchability: whether prescribers stay on TRILIPIX once generic equivalents are available.

What patent litigation affects TRILIPIX and how does it change investment risk?

Featured snippet answer: Patent litigation is relevant to TRILIPIX if it shifts the effective exclusivity date for specific ANDA competitors through injunctions or settlements that delay launch.

How to translate litigation into timeline risk

Investment translation focuses on:

• Whether a settlement includes a stay of approval or an agreed launch date.
• Whether litigation outcomes remove or reinforce patent enforceability.
• Whether court decisions narrow claim scope in a way that accelerates subsequent generic approvals.

What biosimilar risk exists for TRILIPIX?

Featured snippet answer: None. TRILIPIX is a small-molecule fibric-acid drug, not a biologic.

What manufacturing/IP barriers matter for TRILIPIX market competition?

Featured snippet answer: In lipid small molecules, the main manufacturing/IP barrier is usually patent protection over process/formulation rather than biologics-style manufacturing complexity.

Key barriers to model

• Process claims: if still unexpired, they can require redesign or license.
• Formulation-specific manufacturing steps: coating/granulation processes if protected.
• Regulatory comparability: bioequivalence standards and any labeling-driven product differences.

How should an investor think about TRILIPIX in a portfolio context?

Featured snippet answer: TRILIPIX fits as a cashflow-and-contestability asset rather than a long-duration growth platform. The value driver is whether the brand maintains pricing power and share under generic pressure, not whether it can sustain multi-year patent exclusivity.

Base-case underwriting logic

A typical base-case for late-cycle lipid brands:

• Revenue declines with generic penetration over time.
• The rate of decline depends on payer contracting intensity and competitive launches.
• Any remaining patent or settlement-driven protection modestly shifts the curve.

Bull and bear framing (investment mechanics)

• Bull case mechanics: slower switching, stronger payer differentiation, fewer effective generic launches, or successful enforcement against specific ANDAs.
• Bear case mechanics: accelerated generic entry, aggressive rebate competition, and rapid formulary migration.

Key Takeaways

• TRILIPIX is a mature fenofibric-acid franchise in a generic-dominated lipid category; investment outcomes depend on remaining enforceable Orange Book patent listings and the effective timetable for generic erosion.
• Generic entry risk is typically controlled by the last relevant listed patents and any settlement outcomes for ANDAs.
• Formulation/process patents can extend contestability even after drug substance patents end.
• Competitive differentiation is mostly payer- and tolerance-driven rather than patent-driven in late lifecycle.
• Biosimilar risk does not apply because TRILIPIX is a small molecule.

FAQs

1. What Orange Book patents are listed for TRILIPIX and when do they expire?
2. Has TRILIPIX faced any Paragraph IV ANDA challenges, and what were the settlement outcomes?
3. How does TRILIPIX’s labeled indication scope affect payer access versus generic fenofibrate?
4. Which TRILIPIX drug product/formulation attributes could block generic substitution even after drug substance expiration?
5. How does TRILIPIX revenue typically track generic penetration and PBM rebate dynamics in the lipid market?

References (APA)

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA.