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Last Updated: July 6, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203858


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NDA 203858 describes JUXTAPID, which is a drug marketed by Amryt and is included in one NDA. There are nine patents protecting this drug. Additional details are available on the JUXTAPID profile page.

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.
Summary for 203858
Tradename:JUXTAPID
Applicant:Amryt
Ingredient:lomitapide mesylate
Patents:9
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 5MG BASE
Approval Date:Dec 21, 2012TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Mar 7, 2025Product Flag?Substance Flag?Delist Request?
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
Patent:  Start TrialPatent Expiration:Mar 7, 2025Product Flag?Substance Flag?Delist Request?
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
Patent:  Start TrialPatent Expiration:Feb 21, 2020Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF HYPERCHOLESTEROLEMIA, HYPERLIPIDEMIA AND HYPERLIPOPROTEINEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA

Expired US Patents for NDA 203858

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Amryt JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-006 Apr 23, 2015   Start Trial   Start Trial
Amryt JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-001 Dec 21, 2012   Start Trial   Start Trial
Amryt JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-004 Apr 23, 2015   Start Trial   Start Trial
Amryt JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-004 Apr 23, 2015   Start Trial   Start Trial
Amryt JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-001 Dec 21, 2012   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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