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Last Updated: December 14, 2019

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Details for New Drug Application (NDA): 021882

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NDA 021882 describes EXJADE, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the EXJADE profile page.

The generic ingredient in EXJADE is deferasirox. There are twenty drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the deferasirox profile page.
Summary for 021882
Tradename:EXJADE
Applicant:Novartis
Ingredient:deferasirox
Patents:1
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 021882
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EXJADE deferasirox TABLET, FOR SUSPENSION;ORAL 021882 NDA Novartis Pharmaceuticals Corporation 0078-0468 0078-0468-15 30 TABLET, FOR SUSPENSION in 1 BOTTLE (0078-0468-15)
EXJADE deferasirox TABLET, FOR SUSPENSION;ORAL 021882 NDA Novartis Pharmaceuticals Corporation 0078-0469 0078-0469-15 30 TABLET, FOR SUSPENSION in 1 BOTTLE (0078-0469-15)
Paragraph IV (Patent) Challenges for 021882
Tradename Dosage Ingredient NDA Submissiondate
EXJADE TABLET, FOR SUSPENSION;ORAL deferasirox 021882 2011-10-28

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, FOR SUSPENSION;ORALStrength125MG
Approval Date:Nov 2, 2005TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Jul 24, 2022
Regulatory Exclusivity Use:INFORMATION ADDED TO THE LABELING FOR SAFETY & EFFICACY STUDY ENTITLED, A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED CLINICAL TRIAL OF DEFERASIROX IN PATIENTS WITH MYELODYSPLASTIC SYNDROMES (LOW/INT-1 RISK) & TRANSFUSIONAL IRON OVERLOAD
Regulatory Exclusivity Expiration:Dec 12, 2021
Regulatory Exclusivity Use:INFORMATION ADDED TO THE PEDIATRIC USE SECTION OF THE LABELING REGARDING A TRIAL CONDUCTED IN TREATMENT NAIVE PEDIATRIC PATIENTS, AGES 2 YEARS TO < 18 YEARS WITH TRANSFUSIONAL IRON OVERLOAD
Regulatory Exclusivity Expiration:Jan 23, 2020
Regulatory Exclusivity Use:TREATMENT OF CHRONIC IRON OVERLOAD IN PATIENTS 10 YRS. & OLDER WITH NON-TRANSFUSION DEPENDENT THALASSEMIA (NTDT) SYNDROMES AND WITH A LIVER IRON CONCENTRATION OF AT LEAST 5 MG OF IRON PER GRAM OF LIVER DRY WEIGHT & SERUM FERRITIN GREATER THAN 300 MCG/L.

Expired US Patents for NDA 021882

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis EXJADE deferasirox TABLET, FOR SUSPENSION;ORAL 021882-003 Nov 2, 2005   Start Trial   Start Trial
Novartis EXJADE deferasirox TABLET, FOR SUSPENSION;ORAL 021882-001 Nov 2, 2005   Start Trial   Start Trial
Novartis EXJADE deferasirox TABLET, FOR SUSPENSION;ORAL 021882-003 Nov 2, 2005   Start Trial   Start Trial
Novartis EXJADE deferasirox TABLET, FOR SUSPENSION;ORAL 021882-002 Nov 2, 2005   Start Trial   Start Trial
Novartis EXJADE deferasirox TABLET, FOR SUSPENSION;ORAL 021882-002 Nov 2, 2005   Start Trial   Start Trial
Novartis EXJADE deferasirox TABLET, FOR SUSPENSION;ORAL 021882-001 Nov 2, 2005   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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