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Last Updated: May 24, 2022

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.

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Drug patent expirations by year for EXJADE
Drug Prices for EXJADE

See drug prices for EXJADE

Recent Clinical Trials for EXJADE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
DisperSol Technologies, LLCPhase 2
Fondazione Italiana Sindromi Mielodisplastiche OnlusPhase 2
Fondazione Italiana Sindromi Mielodisplastiche-ETSPhase 2

See all EXJADE clinical trials

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

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

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