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Last Updated: August 15, 2022

JUXTAPID Drug Patent Profile


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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. 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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Drug patent expirations by year for JUXTAPID
Drug Prices for JUXTAPID

See drug prices for JUXTAPID

DrugPatentWatch® Estimated Generic Entry Opportunity Date for JUXTAPID
Generic Entry Date for JUXTAPID*:
Constraining patent/regulatory exclusivity:
NDA:
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

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

See all JUXTAPID clinical trials

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 See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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

Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side-effects
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amryt JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-004 Apr 23, 2015 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amryt JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-006 Apr 23, 2015 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amryt JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-004 Apr 23, 2015 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amryt JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-005 Apr 23, 2015 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Amryt JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-003 Dec 21, 2012 See Plans and Pricing See Plans and Pricing
Amryt JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-002 Dec 21, 2012 See Plans and Pricing See Plans and Pricing
Amryt JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-002 Dec 21, 2012 See Plans and Pricing See Plans and Pricing
Amryt JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-006 Apr 23, 2015 See Plans and Pricing See Plans and Pricing
Amryt JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-004 Apr 23, 2015 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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

Patent: 05221656
Estimated Expiration: See Plans and Pricing

Canada

Patent: 58766
Estimated Expiration: See Plans and Pricing

Patent: 10191
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0130115
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 14218
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 25234
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 25234
Estimated Expiration: See Plans and Pricing

Japan

Patent: 97296
Estimated Expiration: See Plans and Pricing

Patent: 02760
Estimated Expiration: See Plans and Pricing

Patent: 89918
Estimated Expiration: See Plans and Pricing

Patent: 07527433
Estimated Expiration: See Plans and Pricing

Patent: 12232995
Estimated Expiration: See Plans and Pricing

Patent: 14208683
Estimated Expiration: See Plans and Pricing

Patent: 16135762
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 725234
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 070
Estimated Expiration: See Plans and Pricing

Netherlands

Patent: 0634
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 9721
Estimated Expiration: See Plans and Pricing

Poland

Patent: 25234
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 25234
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 825
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 25234
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1494067
Estimated Expiration: See Plans and Pricing

Patent: 060129082
Estimated Expiration: See Plans and Pricing

Patent: 130004942
Estimated Expiration: See Plans and Pricing

Spain

Patent: 99721
Estimated Expiration: See Plans and Pricing

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
Israel 116917 See Plans and Pricing
Mexico 9705005 INHIBIDORES DE LA PROTEINA DE TRANSFERENCIA DE TRIGLICERIDOS MICROSOMICOS Y METODO. (INHIBITORS OF MICROSOMAL TRIGLYCERIDE TRANSFER PROTEIN AND METHOD.) See Plans and Pricing
European Patent Office 0643057 See Plans and Pricing
Austria 283851 See Plans and Pricing
Australia 3406493 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for JUXTAPID

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1725234 2014C/002 Belgium See Plans and Pricing 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 14C0003 France See Plans and Pricing PRODUCT NAME: LOMITAPIDE , OU UN SEL PHARMACEUTIQUEMENT ACTIF DE CELUI-CI.; REGISTRATION NO/DATE: EU/1/13/851/001 20130805
1725234 C300634 Netherlands See Plans and Pricing 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 SPC/GB14/005 United Kingdom See Plans and Pricing 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 PA2014001,C1725234 Lithuania See Plans and Pricing PRODUCT NAME: LOMITAPIDAS; 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Mallinckrodt
McKesson
Baxter
Dow
AstraZeneca

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.