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Information, Expiry & Status of FDA Orange Book Patents covering Nilotinib HCl

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01 NOVARTIS (45)

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01 7169791*PED (3)

02 8163904 (3)

03 8163904*PED (3)

04 8293756 (3)

05 8293756*PED (3)

06 8389537 (3)

07 8389537*PED (3)

08 8415363 (6)

09 8415363*PED (3)

10 8501760 (3)

11 8501760*PED (3)

12 9061029 (6)

13 9061029*PED (3)

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01 Y (15)

02 Blank (30)

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01 Y (15)

02 Blank (30)

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01 2024-01-04 (3)

02 2026-07-18 (12)

03 2027-01-18 (9)

04 2027-09-25 (3)

05 2028-03-25 (3)

06 2028-08-23 (3)

07 2029-02-23 (3)

08 2032-04-07 (6)

09 2032-10-07 (3)

URL Supplier Web Content
9061029
Y
2032-04-07
U-1374
22068
TREATMENT OF PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOID LEUKEMIA (PH+CML)
3
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8389537
2026-07-18
U-1374
22068
TREATMENT OF PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOID LEUKEMIA (PH+CML)
3
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8389537
2026-07-18
U-1374
22068
TREATMENT OF PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOID LEUKEMIA (PH+CML)
2
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8415363
Y
Y
2026-07-18
U-1407
22068
TREATMENT OF NEWLY DIAGNOSED PHILADELPIA CHROMOSOME POSITIVE CHRONIC MYELOID LEUKEMIA (PH + CML)
2
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9061029
Y
2032-04-07
U-1374
22068
TREATMENT OF PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOID LEUKEMIA (PH+CML)
1
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URL Supplier Web Content
8415363
Y
Y
2026-07-18
U-1407
22068
TREATMENT OF NEWLY DIAGNOSED PHILADELPIA CHROMOSOME POSITIVE CHRONIC MYELOID LEUKEMIA (PH + CML)
1
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URL Supplier Web Content
9061029
Y
2032-04-07
U-1374
22068
TREATMENT OF PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOID LEUKEMIA (PH+CML)
2
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URL Supplier Web Content
8415363
Y
Y
2026-07-18
U-1407
22068
TREATMENT OF NEWLY DIAGNOSED PHILADELPIA CHROMOSOME POSITIVE CHRONIC MYELOID LEUKEMIA (PH + CML)
3
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9061029
Y
2032-04-07
U-3231
22068
3
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9061029
Y
2032-04-07
U-3231
22068
2
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