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Last Updated: January 25, 2022

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207968


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NDA 207968 describes JADENU SPRINKLE, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. Additional details are available on the JADENU SPRINKLE profile page.

The generic ingredient in JADENU SPRINKLE 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 207968
Tradename:JADENU SPRINKLE
Applicant:Novartis
Ingredient:deferasirox
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 207968
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
JADENU SPRINKLE deferasirox GRANULE;ORAL 207968 NDA Novartis Pharmaceuticals Corporation 0078-0713 0078-0713-15 30 PACKET in 1 CARTON (0078-0713-15) > 1 GRANULE in 1 PACKET (0078-0713-19)
JADENU SPRINKLE deferasirox GRANULE;ORAL 207968 NDA Novartis Pharmaceuticals Corporation 0078-0720 0078-0720-15 30 PACKET in 1 CARTON (0078-0720-15) > 1 GRANULE in 1 PACKET (0078-0720-19)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GRANULE;ORALStrength90MG
Approval Date:May 18, 2017TE: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:Jul 23, 2023
Regulatory Exclusivity Use:REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY ICL670E2419 (THETIS TRIAL) TO SUPPORT PMR 3342-2 AND 3342-3

Expired US Patents for NDA 207968

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis JADENU SPRINKLE deferasirox GRANULE;ORAL 207968-001 May 18, 2017 ⤷  Try it Free ⤷  Try it Free
Novartis JADENU SPRINKLE deferasirox GRANULE;ORAL 207968-003 May 18, 2017 ⤷  Try it Free ⤷  Try it Free
Novartis JADENU SPRINKLE deferasirox GRANULE;ORAL 207968-002 May 18, 2017 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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