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TRILIPIX Drug Patent Profile

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When do Trilipix patents expire, and what generic alternatives are available?

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. Twelve 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

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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:	2,599
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for TRILIPIX
What excipients (inactive ingredients) are in TRILIPIX?	TRILIPIX excipients list
DailyMed Link:	TRILIPIX at DailyMed

Drug patent expirations by year 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

Anatomical Therapeutic Chemical (ATC) Classes for TRILIPIX

C10AB	Fibrates
C10A	LIPID MODIFYING AGENTS, PLAIN
C10	LIPID MODIFYING AGENTS
C	Cardiovascular system

C10AB	Fibrates
C10A	LIPID MODIFYING AGENTS, PLAIN
C10	LIPID MODIFYING AGENTS
C	Cardiovascular system

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.

Patents protecting TRILIPIX

Salts of fenofibric acid and pharmaceutical formulations thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

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Glossary

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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	⤷ Try a Trial	⤷ Try a Trial		Y		⤷ Try a Trial
Abbvie	TRILIPIX	choline fenofibrate	CAPSULE, DELAYED RELEASE;ORAL	022224-002	Dec 15, 2008	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial		Y		⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for TRILIPIX

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

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Country	Patent Number	Title	Estimated Expiration
Austria	359777		⤷ Try a Trial
European Patent Office	1829541	Formulation comprenant de l'acide fénofibrique ou l'un de ses sels physiologiquement acceptable (Formulation comprising fenofibric acid or a physiologically acceptable salt thereof)	⤷ Try a Trial
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)	⤷ Try a Trial
Spain	2286486		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for TRILIPIX

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0050793	94C0009	Belgium	⤷ Try a Trial	PRODUCT NAME: COLFOSCERIL PALMITAS (DIPALMITOYLPHOSPHATIDYLCHOLINE) (DPPC); NAT REG.: 251 IS 142 F 12; FIRST REG.: GB PL 0003/0283 19901214
1746976	2017C/027	Belgium	⤷ Try a Trial	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
1746976	CA 2017 00030	Denmark	⤷ Try a Trial	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	⤷ Try a Trial	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description