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. Seventeen 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: | 122 |
Clinical Trials: | 35 |
Patent Applications: | 1,411 |
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 |
---|---|
DisperSol Technologies, LLC | Phase 2 |
Fondazione Italiana Sindromi Mielodisplastiche Onlus | Phase 2 |
Fondazione Italiana Sindromi Mielodisplastiche-ETS | Phase 2 |
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: 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 | EXJADE | deferasirox | TABLET, FOR SUSPENSION;ORAL | 021882-001 | Nov 2, 2005 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Novartis | EXJADE | deferasirox | TABLET, FOR SUSPENSION;ORAL | 021882-002 | Nov 2, 2005 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Novartis | EXJADE | deferasirox | TABLET, FOR SUSPENSION;ORAL | 021882-001 | Nov 2, 2005 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Novartis | EXJADE | deferasirox | TABLET, FOR SUSPENSION;ORAL | 021882-002 | Nov 2, 2005 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Novartis | EXJADE | deferasirox | TABLET, FOR SUSPENSION;ORAL | 021882-003 | Nov 2, 2005 | AB | RX | Yes | Yes | 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 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 | See Plans and Pricing | See Plans and Pricing |
Novartis | EXJADE | deferasirox | TABLET, FOR SUSPENSION;ORAL | 021882-002 | Nov 2, 2005 | See Plans and Pricing | See Plans and Pricing |
Novartis | EXJADE | deferasirox | TABLET, FOR SUSPENSION;ORAL | 021882-002 | Nov 2, 2005 | See Plans and Pricing | See Plans and Pricing |
Novartis | EXJADE | deferasirox | TABLET, FOR SUSPENSION;ORAL | 021882-003 | Nov 2, 2005 | See Plans and Pricing | See Plans and Pricing |
Novartis | EXJADE | deferasirox | TABLET, FOR SUSPENSION;ORAL | 021882-001 | Nov 2, 2005 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for EXJADE
See the table below for patents covering EXJADE around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Poland | 330119 | See Plans and Pricing | |
Denmark | 0914118 | See Plans and Pricing | |
Slovakia | 284319 | See Plans and Pricing | |
Bulgaria | 64248 | See Plans and Pricing | |
Norway | 986024 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for EXJADE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0914118 | SPC/GB07/002 | United Kingdom | See Plans and Pricing | 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 | C00914118/01 | Switzerland | See Plans and Pricing | PRODUCT NAME: DEFERASIROX; REGISTRATION NUMBER/DATE: SWISSMEDIC 57466 03.11.2005 |
0914118 | PA2007001,C0914118 | Lithuania | See Plans and Pricing | 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 | PA2007001 | Lithuania | See Plans and Pricing | 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 | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |