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Generated: May 20, 2019

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EXJADE Drug Profile

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When do Exjade patents expire, and when can generic versions of Exjade launch?

Exjade is a drug marketed by Novartis and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has forty-eight patent family members in thirty-four countries.

The generic ingredient in EXJADE is deferasirox. There are twenty drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the deferasirox profile page.

US Patents and Regulatory Information for EXJADE

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 ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Novartis EXJADE deferasirox TABLET, FOR SUSPENSION;ORAL 021882-002 Nov 2, 2005 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis EXJADE deferasirox TABLET, FOR SUSPENSION;ORAL 021882-001 Nov 2, 2005 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis EXJADE deferasirox TABLET, FOR SUSPENSION;ORAL 021882-002 Nov 2, 2005 AB RX Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Novartis EXJADE deferasirox TABLET, FOR SUSPENSION;ORAL 021882-003 Nov 2, 2005 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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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 ➤ Sign Up ➤ Sign Up
Novartis EXJADE deferasirox TABLET, FOR SUSPENSION;ORAL 021882-002 Nov 2, 2005 ➤ Sign Up ➤ Sign Up
Novartis EXJADE deferasirox TABLET, FOR SUSPENSION;ORAL 021882-002 Nov 2, 2005 ➤ Sign Up ➤ Sign Up
Novartis EXJADE deferasirox TABLET, FOR SUSPENSION;ORAL 021882-003 Nov 2, 2005 ➤ Sign Up ➤ Sign Up
Novartis EXJADE deferasirox TABLET, FOR SUSPENSION;ORAL 021882-001 Nov 2, 2005 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for EXJADE
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 125 mg, 250 mg, and 500 mg ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for EXJADE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0914118 PA2007001,C0914118 Lithuania ➤ Sign Up 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 C00914118/01 Switzerland ➤ Sign Up PRODUCT NAME: DEFERASIROX; REGISTRATION NUMBER/DATE: SWISSMEDIC 57466 03.11.2005
0914118 06C0049 France ➤ Sign Up 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 PA2007001 Lithuania ➤ Sign Up 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 SPC 035/2006 Ireland ➤ Sign Up SPC 035/2006: 20070528, EXPIRES: 20210827
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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