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Last Updated: December 3, 2023

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. Twenty 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 one FDA Regulatory Exclusivity.

FDA Regulatory Exclusivity protecting JADENU SPRINKLE

REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY ICL670E2419 (THETIS TRIAL) TO SUPPORT PMR 3342-2 AND 3342-3
Exclusivity Expiration: ⤷  Try a Trial

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

EU/EMA Drug Approvals for JADENU SPRINKLE

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Mylan Pharmaceuticals Limited Deferasirox Mylan deferasirox EMEA/H/C/005014
Deferasirox Mylan is indicated forthe treatment of chronic iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) in patients with beta thalassaemia major aged 6 years and olderthe treatment of chronic iron overload due to blood transfusions when deferoxamine therapy is contraindicated or inadequate in the following patient groups:in paediatric patients with beta thalassaemia major with iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) aged 2 to 5 years,in adult and paediatric patients with beta thalassaemia major with iron overload due to infrequent blood transfusions (
Authorised yes no no 2019-09-26
Novartis Europharm Limited Exjade deferasirox EMEA/H/C/000670
Exjade is indicated for the treatment of chronic iron overload due to frequent blood transfusions (≥ 7 ml/kg/month of packed red blood cells) in patients with beta thalassaemia major aged six years and older.Exjade is also indicated for the treatment of chronic iron overload due to blood transfusions when deferoxamine therapy is contraindicated or inadequate in the following patient groups:in patients with beta thalassaemia major with iron overload due to frequent blood transfusions (≥ 7 ml/kg/month of packed red blood cells) aged two to five years;in patients with beta thalassaemia major with iron overload due to infrequent blood transfusions (< 7 ml/kg/month of packed red blood cells) aged two years and older;in patients with other anaemias aged two years and older.Exjade is also indicated for the treatment of chronic iron overload requiring chelation therapy when deferoxamine therapy is contraindicated or inadequate in patients with non-transfusion-dependent thalassaemia syndromes aged 10 years and older.
Authorised no no no 2006-08-28
Accord Healthcare S.L.U. Deferasirox Accord deferasirox EMEA/H/C/005156
Deferasirox Accord is indicated for the treatment of chronic iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) in patients with beta thalassaemia major aged 6 years and older.Deferasirox Accord is also indicated for the treatment of chronic iron overload due to blood transfusions when deferoxamine therapy is contraindicated or inadequate in the following patient groups:in paediatric patients with beta thalassaemia major with iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) aged 2 to 5 years,in adult and paediatric patients with beta thalassaemia major with iron overload due to infrequent blood transfusions (
Authorised yes no no 2020-01-09
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for JADENU SPRINKLE

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

Country Patent Number Title Estimated Expiration
Hungary 9903111 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 9749395 ⤷  Try a Trial
Australia 3262997 ⤷  Try a Trial
Japan 2000507601 ⤷  Try a Trial
Germany 122007000020 ⤷  Try a Trial
Czech Republic 291470 Substituované 3,5-difenyl-1,2,4-triazoly, jejich použití jako léčiv chelatujících kovy a způsob jejich přípravy (Substituted 3,5-diphenyl-1,2,4-triazoles, their use as iron chelating medicaments and process of their preparation) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for JADENU SPRINKLE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0914118 SPC 035/2006 Ireland ⤷  Try a Trial SPC 035/2006: 20070528, EXPIRES: 20210827
0914118 300248 Netherlands ⤷  Try a Trial 300248, 20170624, EXPIRES: 20210827
0914118 SPC/GB07/002 United Kingdom ⤷  Try a Trial SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB07/002 GRANTED TO NOVARTIS AG IN RESPECT OF THE PRODUCT DEFERASIROX AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, ESPECIALLY 4-(3,5-BIS(2-HYDROXYPHENYL)-(1,2,4) TRIAZOL-L-YL) BENZOIC ACID, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6179 DATED 24 OCTOBER 2007 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 30 AUGUST 2021.
0914118 290 Finland ⤷  Try a Trial
0914118 CA 2006 00035 Denmark ⤷  Try a Trial
0914118 06C0049 France ⤷  Try a Trial 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
>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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