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JUXTAPID Drug Patent Profile

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

Juxtapid is a drug marketed by Chiesi 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. Three 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

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Summary for JUXTAPID

International Patents:	27
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	71
Clinical Trials:	5
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

Drug patent expirations by year for JUXTAPID

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

Generic Entry Date for JUXTAPID^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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 eight US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of JUXTAPID is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
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

Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side effects
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES

Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side-effects
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES

Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side-effects
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A DOSING REGIMEN FOR THE TREATMENT OFHYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES

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

Expired US Patents for JUXTAPID

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-005	Apr 23, 2015	⤷ Sign Up	⤷ Sign Up
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-003	Dec 21, 2012	⤷ Sign Up	⤷ Sign Up
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-003	Dec 21, 2012	⤷ Sign Up	⤷ Sign Up
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-001	Dec 21, 2012	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for JUXTAPID

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

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Country	Patent Number	Title	Estimated Expiration
Australia	670930		⤷ Sign Up
Bulgaria	101717		⤷ Sign Up
Denmark	0584446		⤷ Sign Up
Slovakia	113597	INHIBITORS OF MICROSOMAL TRIGLYCERIDE TRANSFER PROTEIN AND METHOD FOR PREPARATION THEREOF	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for JUXTAPID

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1725234	122014000003	Germany	⤷ Sign Up	PRODUCT NAME: LOMITAPID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON ODER DAS PIPERIDIN-N-OXID DAVON; REGISTRATION NO/DATE: EU/1/13/851/001-003 20130731
1725234	SPC/GB14/005	United Kingdom	⤷ Sign Up	PRODUCT NAME: LOMITAPIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF OR THE PIPERIDINE N-OXIDE THEREOF; REGISTERED: UK EU/1/13/851/001 20130805; UK EU/1/13/851/002 20130805; UK EU/1/13/851/003 20130805
1725234	132014902228079	Italy	⤷ Sign Up	PRODUCT NAME: LOMITAPIDE E OGNI SUA FORMA TERAPEUTICAMENTE EQUIVALENTE COME PROTETTA DAL BREVETTO BASE(LOJUXTA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/851/001/-003, 20130805
1725234	C20140001 00107	Estonia	⤷ Sign Up	PRODUCT NAME: LOMITAPIID;REG NO/DATE: K(2013)5153(LOPLIK) 05.08.2013
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description