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Last Updated: May 26, 2022

JADENU SPRINKLE Drug Patent Profile


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When do Jadenu Sprinkle patents expire, and when can generic versions of Jadenu Sprinkle launch?

Jadenu Sprinkle is a drug marketed by Novartis and is included in one NDA.

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.

DrugPatentWatch® Litigation and Generic Entry Outlook for Jadenu Sprinkle

A generic version of JADENU SPRINKLE was approved as deferasirox by ACTAVIS ELIZABETH on January 26th, 2016.

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US Patents and Regulatory Information for JADENU SPRINKLE

JADENU SPRINKLE is protected by zero US patents and two FDA Regulatory Exclusivities.

FDA Regulatory Exclusivity protecting JADENU SPRINKLE

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
Exclusivity Expiration: See Plans and Pricing

REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY ICL670E2419 (THETIS TRIAL) TO SUPPORT PMR 3342-2 AND 3342-3
Exclusivity Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis JADENU SPRINKLE deferasirox GRANULE;ORAL 207968-001 May 18, 2017 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis JADENU SPRINKLE deferasirox GRANULE;ORAL 207968-002 May 18, 2017 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis JADENU SPRINKLE deferasirox GRANULE;ORAL 207968-001 May 18, 2017 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for JADENU SPRINKLE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis JADENU SPRINKLE deferasirox GRANULE;ORAL 207968-002 May 18, 2017 See Plans and Pricing See Plans and Pricing
Novartis JADENU SPRINKLE deferasirox GRANULE;ORAL 207968-001 May 18, 2017 See Plans and Pricing See Plans and Pricing
Novartis JADENU SPRINKLE deferasirox GRANULE;ORAL 207968-003 May 18, 2017 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for JADENU SPRINKLE

See the table below for patents covering JADENU SPRINKLE around the world.

Country Patent Number Title Estimated Expiration
Hungary 226232 SUBSTITUTED 3,5-DIPHENYL-1,2,4-TRIAZOLES, THEIR PRODUCTION PROCESSES, THEIR USE AS PHARMACEUTICAL METAL CHELATORS AND PHARAMCEUTICAL COMPOSITIONS COMPRISING SAID COMPOSITIONS See Plans and Pricing
Hong Kong 1020530 See Plans and Pricing
Austria 226435 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for JADENU SPRINKLE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0914118 06C0049 France See Plans and Pricing PRODUCT NAME: DEFERASIROX OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE IN FRANCE: EU/1/06/356/001 DU 20060828; REGISTRATION NO/DATE AT EEC: EU/1/06/356/001 DU 20060828
0914118 SPC 035/2006 Ireland See Plans and Pricing SPC 035/2006: 20070528, EXPIRES: 20210827
0914118 300248 Netherlands See Plans and Pricing 300248, 20170624, EXPIRES: 20210827
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Harvard Business School
Boehringer Ingelheim
Dow
Medtronic
Colorcon

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