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Generated: November 15, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203858

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NDA 203858 describes JUXTAPID, which is a drug marketed by Aegerion and is included in one NDA. It is available from one supplier. 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. One supplier is listed for this compound. Additional details are available on the lomitapide mesylate profile page.
Summary for 203858
Tradename:JUXTAPID
Applicant:Aegerion
Ingredient:lomitapide mesylate
Patents:9
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 203858
Generic Entry Date for 203858*:
Constraining patent/regulatory exclusivity:
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.

Suppliers and Packaging for NDA: 203858
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858 NDA Aegerion Pharmaceuticals, Inc. 76431-105 76431-105-01 28 CAPSULE in 1 BOTTLE (76431-105-01)
JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858 NDA Aegerion Pharmaceuticals, Inc. 76431-110 76431-110-01 28 CAPSULE in 1 BOTTLE (76431-110-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 5MG BASE
Approval Date:Dec 21, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 21, 2019
Regulatory Exclusivity Use:ADJUNCT TO A LOW-FAT DIET AND OTHER LIPID-LOWERING TREATMENTS, INCLUDING LDL APHERESIS WHERE AVAILABLE, TO REDUCE LDL-C, TC, APOLIPOPROTEIN B, & NON-HDL-C IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA
Patent:➤ Try a Free 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:➤ Try a Free 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
Aegerion JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-001 Dec 21, 2012 ➤ Try a Free Trial ➤ Try a Free Trial
Aegerion JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-003 Dec 21, 2012 ➤ Try a Free Trial ➤ Try a Free Trial
Aegerion JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-002 Dec 21, 2012 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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