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Last Updated: October 23, 2020

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Regulatory Exclusivity: ORPHAN DRUG EXCLUSIVITY

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Drugs with Orphan Drug Exclusivity Regulatory Exclusivity

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Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Exclusivity Expiration Patented / Exclusive Use
Novartis EXJADE deferasirox TABLET, FOR SUSPENSION;ORAL 021882-002 Nov 2, 2005 AB RX Yes No   Start Trial TREATMENT OF CHRONIC IRON OVERLOAD IN PATIENTS 10 YRS. & OLDER WITH NON-TRANSFUSION DEPENDENT THALASSEMIA (NTDT) SYNDROMES AND WITH A LIVER IRON CONCENTRATION OF AT LEAST 5 MG OF IRON PER GRAM OF LIVER DRY WEIGHT & SERUM FERRITIN GREATER THAN 300 MCG/L.
Novartis Pharms Corp JADENU deferasirox TABLET;ORAL 206910-002 Mar 30, 2015 AB RX Yes No   Start Trial TREATMENT OF CHRONIC IRON OVERLOAD IN PATIENTS 10 YRS. & OLDER WITH NON-TRANSFUSION DEPENDENT THALASSEMIA (NTDT) SYNDROMES AND WITH A LIVER IRON CONCENTRATION OF AT LEAST 5 MG OF IRON PER GRAM OF LIVER DRY WEIGHT & SERUM FERRITIN GREATER THAN 300 MCG/L.
Novartis EXJADE deferasirox TABLET, FOR SUSPENSION;ORAL 021882-001 Nov 2, 2005 AB RX Yes No   Start Trial TREATMENT OF CHRONIC IRON OVERLOAD IN PATIENTS 10 YRS. & OLDER WITH NON-TRANSFUSION DEPENDENT THALASSEMIA (NTDT) SYNDROMES AND WITH A LIVER IRON CONCENTRATION OF AT LEAST 5 MG OF IRON PER GRAM OF LIVER DRY WEIGHT & SERUM FERRITIN GREATER THAN 300 MCG/L.
Novartis Pharms Corp JADENU deferasirox TABLET;ORAL 206910-001 Mar 30, 2015 AB RX Yes No   Start Trial TREATMENT OF CHRONIC IRON OVERLOAD IN PATIENTS 10 YRS. & OLDER WITH NON-TRANSFUSION DEPENDENT THALASSEMIA (NTDT) SYNDROMES AND WITH A LIVER IRON CONCENTRATION OF AT LEAST 5 MG OF IRON PER GRAM OF LIVER DRY WEIGHT & SERUM FERRITIN GREATER THAN 300 MCG/L.
Novartis EXJADE deferasirox TABLET, FOR SUSPENSION;ORAL 021882-003 Nov 2, 2005 AB RX Yes Yes   Start Trial TREATMENT OF CHRONIC IRON OVERLOAD IN PATIENTS 10 YRS. & OLDER WITH NON-TRANSFUSION DEPENDENT THALASSEMIA (NTDT) SYNDROMES AND WITH A LIVER IRON CONCENTRATION OF AT LEAST 5 MG OF IRON PER GRAM OF LIVER DRY WEIGHT & SERUM FERRITIN GREATER THAN 300 MCG/L.
Novartis Pharms Corp JADENU deferasirox TABLET;ORAL 206910-003 Mar 30, 2015 AB RX Yes Yes   Start Trial TREATMENT OF CHRONIC IRON OVERLOAD IN PATIENTS 10 YRS. & OLDER WITH NON-TRANSFUSION DEPENDENT THALASSEMIA (NTDT) SYNDROMES AND WITH A LIVER IRON CONCENTRATION OF AT LEAST 5 MG OF IRON PER GRAM OF LIVER DRY WEIGHT & SERUM FERRITIN GREATER THAN 300 MCG/L.
Novartis GLEEVEC imatinib mesylate TABLET;ORAL 021588-001 Apr 18, 2003 AB RX Yes No   Start Trial TREATMENT OF PEDIATRIC PATIENTS WITH NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (PH+ ALL) IN COMBINATION WITH CHEMOTHERAPY, APPROVED UNDER NDA #21588/S-037
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Exclusivity Expiration >Patented / Exclusive Use

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Serving leading biopharmaceutical companies globally:

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