EXJADE Drug Patent Profile
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Which patents cover Exjade, and what generic alternatives are available?
Exjade is a drug marketed by Novartis and is included in one NDA.
The generic ingredient in EXJADE is deferasirox. There are twenty drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the deferasirox profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Exjade
A generic version of EXJADE was approved as deferasirox by ACTAVIS ELIZABETH on January 26th, 2016.
Summary for EXJADE
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 141 |
Clinical Trials: | 36 |
Patent Applications: | 1,584 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for EXJADE |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for EXJADE |
What excipients (inactive ingredients) are in EXJADE? | EXJADE excipients list |
DailyMed Link: | EXJADE at DailyMed |


Recent Clinical Trials for EXJADE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Phase 2 |
DisperSol Technologies, LLC | Phase 2 |
Fondazione Italiana Sindromi Mielodisplastiche-ETS | Phase 2 |
Pharmacology for EXJADE
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 EXJADE
Paragraph IV (Patent) Challenges for EXJADE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
EXJADE | Tablets for Suspension | deferasirox | 125 mg, 250 mg, and 500 mg | 021882 | 1 | 2011-10-28 |
US Patents and Regulatory Information for EXJADE
EXJADE is protected by zero US patents and two FDA Regulatory Exclusivities.
FDA Regulatory Exclusivity protecting EXJADE
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: ⤷ Try a Trial
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 | EXJADE | deferasirox | TABLET, FOR SUSPENSION;ORAL | 021882-001 | Nov 2, 2005 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Novartis | EXJADE | deferasirox | TABLET, FOR SUSPENSION;ORAL | 021882-002 | Nov 2, 2005 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Novartis | EXJADE | deferasirox | TABLET, FOR SUSPENSION;ORAL | 021882-001 | Nov 2, 2005 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Novartis | EXJADE | deferasirox | TABLET, FOR SUSPENSION;ORAL | 021882-002 | Nov 2, 2005 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Novartis | EXJADE | deferasirox | TABLET, FOR SUSPENSION;ORAL | 021882-003 | Nov 2, 2005 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Novartis | EXJADE | deferasirox | TABLET, FOR SUSPENSION;ORAL | 021882-003 | Nov 2, 2005 | 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 EXJADE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | EXJADE | deferasirox | TABLET, FOR SUSPENSION;ORAL | 021882-001 | Nov 2, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | EXJADE | deferasirox | TABLET, FOR SUSPENSION;ORAL | 021882-003 | Nov 2, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | EXJADE | deferasirox | TABLET, FOR SUSPENSION;ORAL | 021882-002 | Nov 2, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | EXJADE | deferasirox | TABLET, FOR SUSPENSION;ORAL | 021882-003 | Nov 2, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | EXJADE | deferasirox | TABLET, FOR SUSPENSION;ORAL | 021882-001 | Nov 2, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | EXJADE | deferasirox | TABLET, FOR SUSPENSION;ORAL | 021882-002 | Nov 2, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for EXJADE
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 EXJADE
See the table below for patents covering EXJADE around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Israel | 127212 | ⤷ Try a Trial | |
South Korea | 20050098029 | ⤷ Try a Trial | |
China | 1146415 | ⤷ Try a Trial | |
New Zealand | 333308 | Substituted 3,5-diphenyl-1,2,4-triazoles and their use as pharmaceutical metal chelators | ⤷ Try a Trial |
Germany | 122007000020 | ⤷ Try a Trial | |
Austria | 226435 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for EXJADE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
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 |
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 | PA2007001,C0914118 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: DEFERASIROXUM; REGISTRATION NO/DATE: EU/1/06/356/001 2006-08-28, EU/1/06/356/002 2006-08-28, EU/1/06/356/003 2006-08-28, EU/1/06/356/004 2006-08-28, EU/1/06/356/005 2006-08-28, EU/1/06/356/00 20060828 |
0914118 | 300248 | Netherlands | ⤷ Try a Trial | 300248, 20170624, EXPIRES: 20210827 |
0914118 | C00914118/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: DEFERASIROX; REGISTRATION NUMBER/DATE: SWISSMEDIC 57466 03.11.2005 |
0914118 | 290 | Finland | ⤷ Try a Trial | |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |