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. There is one patent protecting this drug and two Paragraph IV challenges.

This drug has nineteen patent family members in eleven countries.

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

DrugPatentWatch^® Generic Entry Outlook for Trilipix

There are two Paragraph IV patent challenges for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for TRILIPIX

International Patents:	19
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	182
Clinical Trials:	9
Patent Applications:	2,644
Drug Prices:	Drug price information for TRILIPIX
What excipients (inactive ingredients) are in TRILIPIX?	TRILIPIX excipients list
DailyMed Link:	TRILIPIX at DailyMed

See drug prices for TRILIPIX

See drug sales revenues for TRILIPIX

Recent Clinical Trials for TRILIPIX

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

Sponsor	Phase
Medical University of South Carolina	Phase 4
Chong Kun Dang Pharmaceutical	Phase 1
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Phase 2

See all TRILIPIX clinical trials

Pharmacology for TRILIPIX

Drug Class

Peroxisome Proliferator Receptor alpha Agonist

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

TRILIPIX is protected by one US patents.

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	AB	RX	Yes	No	7,259,186			Y
Abbvie	TRILIPIX	choline fenofibrate	CAPSULE, DELAYED RELEASE;ORAL	022224-002	Dec 15, 2008	AB	RX	Yes	Yes	7,259,186			Y

Expired US Patents for TRILIPIX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	TRILIPIX	choline fenofibrate	CAPSULE, DELAYED RELEASE;ORAL	022224-001	Dec 15, 2008	7,259,186
Abbvie	TRILIPIX	choline fenofibrate	CAPSULE, DELAYED RELEASE;ORAL	022224-002	Dec 15, 2008	7,259,186

International Patents for TRILIPIX

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

Country	Patent Number	Title	Estimated Expiration
China	101480384	Formulation comprising fenofibric acid, a physiologically acceptable salt or derivative thereof
Russian Federation	2500398	КОМПОЗИЦИЯ, ВКЛЮЧАЮЩАЯ ФЕНОФИБРИНОВУЮ КИСЛОТУ ИЛИ ЕЕ ФИЗИОЛОГИЧЕСКИ ПРИЕМЛЕМУЮ СОЛЬ, И КАПСУЛА, ВКЛЮЧАЮЩАЯ КОМПОЗИЦИЮ (COMPOSITION CONTAINING FENOFIBRIC ACID OR PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF, AND CAPSULE CONTAINING COMPOSITION)
Russian Federation	2356549	КОМПОЗИЦИЯ, ВКЛЮЧАЮЩАЯ ФЕНОФИБРИНОВУЮ КИСЛОТУ, ЕЕ ФИЗИОЛОГИЧЕСКИ ПРИЕМЛЕМУЮ СОЛЬ ИЛИ ПРОИЗВОДНОЕ (COMPOSITION CONTAINING PHENOFIBRIN ACID, ITS PHYSIOLOGICALLY ACCEPTABLE SALT OR DERIVATIVE)
Russian Federation	2005122439	КОМПОЗИЦИЯ, ВКЛЮЧАЮЩАЯ ФЕНОФИБРИНОВУЮ КИСЛОТУ, ЕЕ ФИЗИОЛОГИЧЕСКИ ПРИЕМЛЕМУЮ СОЛЬ ИЛИ ПРОИЗВОДНОЕ

Supplementary Protection Certificates for TRILIPIX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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	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

Market Dynamics and Financial Trajectory for the Drug: TRILIPIX

Introduction

TRILIPIX, a next-generation fenofibrate developed by Abbott (now part of AbbVie), has been a significant player in the cholesterol-lowering medication market. Here, we delve into the market dynamics and financial trajectory of TRILIPIX, exploring its approval, marketing strategies, financial performance, and the challenges it faced.

FDA Approval and Marketing

In 2008, TRILIPIX received FDA approval for use in combination with a statin to lower triglycerides and LDL (bad) cholesterol, and to increase HDL (good) cholesterol in adults[4].

Combination Therapy

TRILIPIX was marketed as part of a combination therapy with statins like rosuvastatin, atorvastatin, or simvastatin. Clinical trials demonstrated that this combination significantly improved HDL-C and TG compared to statin therapy alone, and also improved LDL-C compared to TRILIPIX alone[4].

Competitive Advantage

Abbott aimed to transition its existing Tricor patient base to TRILIPIX, leveraging its unique indication for use with a statin as a competitive advantage. This strategy was crucial as Tricor faced generic competition in 2011[4].

Financial Performance

Sales and Revenue

TRILIPIX contributed significantly to Abbott's revenue. In 2008, TriCor (the predecessor to TRILIPIX) sales booked by Abbott in the US were $886 million, a 7% increase from the previous year[3].

By 2013, however, the sales of TRILIPIX and TriCor began to decline due to the loss of exclusivity. Despite this, AbbVie reported a 10.9% increase in sales excluding TRILIPIX and TriCor, driven by other strong products like HUMIRA[2].

Financial Impact

The revenue from TRILIPIX and TriCor was substantial, with Abbott Laboratories generating $1.6 billion from these drugs in a single year. This revenue helped offset the costs associated with conducting further studies on TRILIPIX, which were mandated by the FDA and estimated to cost over $100 million[1].

Market Challenges

Generic Competition

One of the major challenges faced by TRILIPIX was the impending generic competition for Tricor. Abbott's strategy to transition patients to TRILIPIX was aimed at mitigating this impact, but the labeling of TRILIPIX indicated that it offered no incremental cardiovascular benefit over a statin alone, making it harder to convince managed care organizations to prefer it over generics[4].

Regulatory Scrutiny

The FDA's decision to allow TRILIPIX to continue being marketed as a heart attack prevention drug, despite studies showing no substantial reduction in heart attacks, was controversial. The FDA did, however, require Abbott to conduct its own study on TRILIPIX's effects on heart attacks[1].

Marketing Strategies

Fixed-Dose Combinations

Abbott planned to market a fixed-dose combination of TRILIPIX with rosuvastatin (Crestor), which would help address all lipid parameters for patients. This strategy was intended to enhance the drug's market appeal and competitiveness[4].

Clinical Trials and Studies

The approval of TRILIPIX was based on several Phase 3 studies and a 52-week open-label extension study. These studies demonstrated the safety and efficacy of TRILIPIX in combination with statins, which was a key factor in its marketing strategy[4].

Financial Trajectory

Revenue Growth and Decline

The revenue from TRILIPIX and TriCor was a significant component of Abbott's financial performance. However, the loss of exclusivity led to a decline in sales. Despite this, AbbVie's overall revenue continued to grow, driven by other successful products[2].

Operational Costs

The operational costs associated with TRILIPIX, including the mandated study by the FDA, were substantial. However, these costs were manageable given the drug's revenue contribution. Abbott's financial reports showed that the company's overall operating earnings and net earnings continued to grow, even with the decline in TRILIPIX and TriCor sales[2][5].

Industry Impact

Market Positioning

TRILIPIX played a crucial role in Abbott's (now AbbVie) portfolio, particularly in the cardiometabolic segment. Its approval and marketing helped Abbott maintain a strong presence in the cholesterol-lowering medication market, despite the challenges posed by generic competition[3][4].

R&D Investments

The development and marketing of TRILIPIX were part of Abbott's broader R&D strategy. The company continued to invest heavily in research and development, which supported pipeline advancements and the launch of new products[2].

Key Takeaways

• FDA Approval and Marketing: TRILIPIX was approved for use in combination with statins to lower triglycerides and LDL cholesterol and increase HDL cholesterol.
• Financial Performance: TRILIPIX contributed significantly to Abbott's revenue, but sales declined due to the loss of exclusivity.
• Market Challenges: The drug faced generic competition and regulatory scrutiny, including a mandated study by the FDA.
• Marketing Strategies: Abbott focused on fixed-dose combinations and highlighted the results of clinical trials to market TRILIPIX.
• Financial Trajectory: Despite declining sales, AbbVie's overall revenue continued to grow driven by other successful products.

FAQs

What is TRILIPIX used for?

TRILIPIX is used in combination with a statin to lower triglycerides and LDL (bad) cholesterol, and to increase HDL (good) cholesterol in adults.

How did the FDA's decision impact TRILIPIX marketing?

The FDA allowed TRILIPIX to continue being marketed as a heart attack prevention drug despite studies showing no substantial reduction in heart attacks, but required Abbott to conduct its own study on TRILIPIX's effects on heart attacks.

What were the financial implications of the FDA's decision?

The mandated study was estimated to cost over $100 million, but this was manageable given the $1.6 billion revenue generated by TRILIPIX and TriCor.

How did generic competition affect TRILIPIX sales?

Generic competition for Tricor in 2011 led to a decline in TRILIPIX and TriCor sales, despite Abbott's efforts to transition patients to TRILIPIX.

What other products contributed to AbbVie's revenue growth?

Products like HUMIRA, Synthroid, Creon, Zemplar, and Duodopa drove AbbVie's revenue growth, compensating for the decline in TRILIPIX and TriCor sales.

Sources

1. FDA Okays Abbott's Marketing of Trilipix as Combo Medication - Chicago Personal Injury Lawyer Blawg
2. AbbVie Reports Third-Quarter 2013 Financial Results - AbbVie Investors
3. SOLVAY GROUP Consistent implementation of our strategy for sustainable and profitable growth - Solvay Group
4. TriLipix - MM+M - Medical Marketing and Media
5. United States Securities and Exchange Commission - Abbott Investor Relations