JUXTAPID Drug Patent Profile

Which patents cover Juxtapid, and what generic alternatives are available?

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

This drug has twenty-seven patent family members in eighteen countries.

The generic ingredient in JUXTAPID is lomitapide mesylate. There are two drug master file entries 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 March 7, 2025. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for JUXTAPID

International Patents:	27
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	71
Clinical Trials:	5
Formulation / Manufacturing:	see details
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

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
Aegerion Pharmaceuticals, Inc.
Amryt Pharma
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

Anatomical Therapeutic Chemical (ATC) Classes for JUXTAPID

C10AX	Other lipid modifying agents
C10A	LIPID MODIFYING AGENTS, PLAIN
C10	LIPID MODIFYING AGENTS
C	Cardiovascular system

US Patents and Regulatory Information for JUXTAPID

JUXTAPID is protected by eight US patents.

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

Patents protecting JUXTAPID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amryt	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-006	Apr 23, 2015		DISCN	Yes	No
Amryt	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-004	Apr 23, 2015		RX	Yes	No
Amryt	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-006	Apr 23, 2015		DISCN	Yes	No
Amryt	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-004	Apr 23, 2015		RX	Yes	No
Amryt	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-005	Apr 23, 2015		DISCN	Yes	No
Amryt	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-004	Apr 23, 2015		RX	Yes	No

Expired US Patents for JUXTAPID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Amryt	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-003	Dec 21, 2012
Amryt	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-003	Dec 21, 2012
Amryt	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-004	Apr 23, 2015
Amryt	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-001	Dec 21, 2012
Amryt	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-002	Dec 21, 2012
Amryt	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-004	Apr 23, 2015

International Patents for JUXTAPID

When does loss-of-exclusivity occur for JUXTAPID?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Canada

Croatia

Cyprus

Denmark

European Patent Office

Japan

Lithuania

Montenegro

Netherlands

New Zealand

Poland

Portugal

Serbia

Slovenia

South Korea

Spain

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

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

Country	Patent Number	Title	Estimated Expiration
Hungary	218419	Mikroszomális triglicerid transzfer protein (MTP) nagy molekulatömegű alegységének rekombináns úton történő előállítására és a protein és inhibitorainak kimutatására szolgáló eljárások (PROCESS FOR PRODUCING THE GREAT MOLECULAR WEIGHT SUBUNIT OF MICROSOMAL TRIGLYCERIDE TRANSFER PROTEIN USING RECOMBINANT TECHNIQUES AND METHODS FOR DETECTING THE PROTEIN AND ITS INHIBITORS)
Norway	943260
European Patent Office	0643057
Taiwan	486469
Spain	2399721
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)

Supplementary Protection Certificates for JUXTAPID

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1725234	498	Finland
1725234	2014C/002	Belgium		PRODUCT NAME: LOMITAPIDE ET TOUTE FORME THERAPEUTIQUEMENT EQUIVALENTE TELLE QUE PROTEGEE PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/13/851/001 20130805
1725234	CR 2014 00002	Denmark		PRODUCT NAME: LOMITAPID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF ELLER PIPERIDIN N-OXIDET DERAF, HERUNDER LOMITAPIDMESYLAT; REG. NO/DATE: EU/1/13/851/001-003 20130805
1725234	C20140001 00107	Estonia		PRODUCT NAME: LOMITAPIID;REG NO/DATE: K(2013)5153(LOPLIK) 05.08.2013
1725234	300634	Netherlands		PRODUCT NAME: LOMITAPIDE OF HET PIPERIDINE N-OXIDE DAARVAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/13/851/001-003 20130805
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