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Last Updated: March 28, 2020

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. There is one patent protecting this drug. 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. Sixteen 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:1
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:RLD: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
Patent:  Start TrialPatent Expiration:Apr 5, 2019Product Flag?YSubstance Flag?YDelist Request?

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

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