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Serving leading biopharmaceutical companies globally:

US Department of Justice
Julphar
Chubb
Medtronic
Farmers Insurance
Fuji
McKesson
Accenture
Mallinckrodt
Merck

Generated: October 18, 2017

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 seven 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 NDA: 203858

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:7
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 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)

Summary 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, 2017
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Dec 21, 2019
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY
Patent:► SubscribePatent Expiration:Feb 21, 2020Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF HYPERCHOLESTEROLEMIA, HYPERLIPIDEMIA AND HYPERLIPOPROTEINEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA

Expired Orange Book Patents for NDA: 203858

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Aegerion
JUXTAPID
lomitapide mesylate
CAPSULE;ORAL203858-003Dec 21, 2012► Subscribe► Subscribe
Aegerion
JUXTAPID
lomitapide mesylate
CAPSULE;ORAL203858-001Dec 21, 2012► Subscribe► Subscribe
Aegerion
JUXTAPID
lomitapide mesylate
CAPSULE;ORAL203858-002Dec 21, 2012► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Baxter
Chubb
Citi
Dow
UBS
AstraZeneca
Deloitte
Moodys
QuintilesIMS

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 verifification 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.

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