JUXTAPID Drug Patent Profile

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

Juxtapid is a drug marketed by Chiesi and is included in one NDA. There are two patents protecting this drug.

The generic ingredient in JUXTAPID is lomitapide mesylate. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the lomitapide mesylate profile page.

DrugPatentWatch^® Generic Entry Outlook for Juxtapid

Juxtapid was eligible for patent challenges on December 21, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 25, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for JUXTAPID

US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	71
Clinical Trials:	5
Patent Applications:	880
Drug Prices:	Drug price information for JUXTAPID
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for JUXTAPID
What excipients (inactive ingredients) are in JUXTAPID?	JUXTAPID excipients list
DailyMed Link:	JUXTAPID at DailyMed

See drug prices for JUXTAPID

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for JUXTAPID

Constraining patent/regulatory exclusivity:

NEW STRENGTH

NDA:

203858

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for JUXTAPID

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

Sponsor	Phase
Amryt Pharma
Aegerion Pharmaceuticals, Inc.
Aegerion Pharmaceuticals, Inc.	Phase 1

See all JUXTAPID clinical trials

Pharmacology for JUXTAPID

Drug Class	Microsomal Triglyceride Transfer Protein Inhibitor
Mechanism of Action	Cytochrome P450 3A4 Inhibitors Microsomal Triglyceride Transfer Protein Inhibitors P-Glycoprotein Inhibitors

US Patents and Regulatory Information for JUXTAPID

JUXTAPID is protected by two US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on NEW STRENGTH.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-007	Feb 25, 2026		RX	Yes	No	12,472,172
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-006	Apr 23, 2015		DISCN	Yes	No	7,932,268
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-002	Dec 21, 2012		RX	Yes	No	7,932,268
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-001	Dec 21, 2012		RX	Yes	No	7,932,268

Expired US Patents for JUXTAPID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-001	Dec 21, 2012	9,861,622
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-003	Dec 21, 2012	8,618,135
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-003	Dec 21, 2012	10,016,404
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-003	Dec 21, 2012	9,861,622

International Patents for JUXTAPID

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

Country	Patent Number	Title	Estimated Expiration
Australia	2005221656	Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side-effects
Canada	2558766	TRAITEMENT A FAIBLES EFFETS SECONDAIRES CONTRE DES AFFECTIONS LIEES A L'HYPERLIPIDEMIE ET L'HYPERCHOLESTEROLEMIE (METHODS FOR TREATING DISORDERS OR DISEASES ASSOCIATED WITH HYPERLIPIDEMIA AND HYPERCHOLESTEROLEMIA WHILE MINIMIZING SIDE-EFFECTS)
Canada	2910191	L'UTILISATION D'INHIBITEURS MTP POUR LE TRAITEMENT A FAIBLES EFFETS SECONDAIRES CONTRE DES AFFECTIONS LIEES A L'HYPERLIPIDEMIE ET L'HYPERCHOLESTEROLEMIE (THE USE OF MTP INHIBITORS FOR TREATING DISORDERS OR DISEASES ASSOCIATED WITH HYPERLIPIDEMIA AND HYPERCHOLESTEROLEMIA WHILE MINIMIZING SIDE EFFECTS)
Cyprus	1114218

Supplementary Protection Certificates for JUXTAPID

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1725234	CA 2014 00002	Denmark		PRODUCT NAME: LOMITAPID OG ENHVER TERAPEUTISK AEKVIVALENT FORM DERAF, SOM BESKYTTET I GRUNDPATENTET; REG. NO/DATE: EU/1/13/851/001-003 20130731
1725234	C300634	Netherlands		PRODUCT NAME: LOMITAPIDE EN ELKE THERAPEUTISCH EQUIVALENTE VORM DAARVAN, ZOALS DOOR HET BASISOCTROOI BESCHERMD; REGISTRATION NO/DATE: EU/1/13/851/001-003 20130731
1725234	PA2014001	Lithuania		PRODUCT NAME: LOMITAPIDUM; REGISTRATION NO/DATE: EU/1/13/851/001, 2013 07 31 EU/1/13/851/002, 2013 07 31 EU/1/13/851/003 20130731
1725234	C20140001 00107	Estonia		PRODUCT NAME: LOMITAPIID;REG NO/DATE: K(2013)5153(LOPLIK) 05.08.2013