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Last Updated: December 23, 2024

Details for New Drug Application (NDA): 203858


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NDA 203858 describes JUXTAPID, which is a drug marketed by Chiesi and is included in one NDA. It is available from three suppliers. 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. Three suppliers are listed for this compound. Additional details are available on the lomitapide mesylate profile page.
Summary for 203858
Tradename:JUXTAPID
Applicant:Chiesi
Ingredient:lomitapide mesylate
Patents:8
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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 Chiesi USA, Inc. 10122-405 10122-405-28 28 CAPSULE in 1 BOTTLE (10122-405-28)
JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858 NDA Chiesi USA, Inc. 10122-410 10122-410-28 28 CAPSULE in 1 BOTTLE (10122-410-28)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 5MG BASE
Approval Date:Dec 21, 2012TE:RLD:Yes
Patent:10,016,404Patent 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:10,555,938Patent 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:7,932,268Patent Expiration:Aug 19, 2027Product 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

Expired US Patents for NDA 203858

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Chiesi JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-002 Dec 21, 2012 6,492,365 ⤷  Subscribe
Chiesi JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-001 Dec 21, 2012 5,712,279 ⤷  Subscribe
Chiesi JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-002 Dec 21, 2012 5,712,279 ⤷  Subscribe
Chiesi JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-003 Dec 21, 2012 6,492,365 ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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.