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Last Updated: June 5, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206910


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NDA 206910 describes JADENU, which is a drug marketed by Novartis Pharms Corp and Novartis and is included in two NDAs. It is available from one supplier. There is one patent protecting this drug and three Paragraph IV challenges. Additional details are available on the JADENU profile page.

The generic ingredient in JADENU is deferasirox. There are twenty drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the deferasirox profile page.
Summary for 206910
Tradename:JADENU
Applicant:Novartis Pharms Corp
Ingredient:deferasirox
Patents:1
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 206910
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
JADENU deferasirox TABLET;ORAL 206910 NDA Novartis Pharmaceuticals Corporation 0078-0654 0078-0654-15 30 TABLET, FILM COATED in 1 BOTTLE (0078-0654-15)
JADENU deferasirox TABLET;ORAL 206910 NDA Novartis Pharmaceuticals Corporation 0078-0655 0078-0655-15 30 TABLET, FILM COATED in 1 BOTTLE (0078-0655-15)
Paragraph IV (Patent) Challenges for 206910
Tradename Dosage Ingredient NDA Submissiondate
JADENU TABLET;ORAL deferasirox 206910 2016-04-21
JADENU TABLET;ORAL deferasirox 206910 2015-10-19

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength90MG
Approval Date:Mar 30, 2015TE: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 206910

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharms Corp JADENU deferasirox TABLET;ORAL 206910-003 Mar 30, 2015   Start Trial   Start Trial
Novartis Pharms Corp JADENU deferasirox TABLET;ORAL 206910-001 Mar 30, 2015   Start Trial   Start Trial
Novartis Pharms Corp JADENU deferasirox TABLET;ORAL 206910-002 Mar 30, 2015   Start Trial   Start Trial
Novartis Pharms Corp JADENU deferasirox TABLET;ORAL 206910-001 Mar 30, 2015   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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