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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Covington
Harvard Business School
Fuji
Johnson and Johnson
Medtronic
Accenture
Baxter
Chinese Patent Office

Generated: April 20, 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 eight 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:8
Formulation / Manufacturing:see details
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 N 76431-105-01
JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858 NDA Aegerion Pharmaceuticals, Inc. 76431-110 N 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:➤ Sign UpPatent Expiration:Feb 21, 2020Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF HYPERCHOLESTEROLEMIA, HYPERLIPIDEMIA AND HYPERLIPOPROTEINEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA
Patent:➤ Sign UpPatent Expiration:Dec 10, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF HYPERCHOLESTEROLEMIA BY DECREASING THE AMOUNT OR ACTIVITY OF MICROSOMAL TRIGLYCERIDE TRANSFER PROTEIN 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 203858-003 Dec 21, 2012 ➤ Sign Up ➤ Sign Up
Aegerion JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-001 Dec 21, 2012 ➤ Sign Up ➤ Sign Up
Aegerion JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-002 Dec 21, 2012 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Boehringer Ingelheim
McKesson
US Army
Johnson and Johnson
Chinese Patent Office
Baxter
Dow
Fuji

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