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.
Summary for JADENU SPRINKLE


Pharmacology for JADENU SPRINKLE
Drug Class | Iron Chelator |
Mechanism of Action | Cytochrome P450 1A2 Inhibitors Cytochrome P450 2C8 Inhibitors Cytochrome P450 3A4 Inducers Iron Chelating Activity |
Anatomical Therapeutic Chemical (ATC) Classes for JADENU SPRINKLE
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 |