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Last Updated: October 23, 2019

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Regulatory Exclusivity Expiring in 2025

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Drugs with Regulatory Exclusivity Expiring in 2025

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Exclusivity Expiration Patented / Exclusive Use
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-005 Oct 28, 2010 RX Yes No   Start Trial INDICATED FOR THE TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) IN COMBINATION WITH CHEMOTHERAPY
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-004 May 30, 2008 RX Yes Yes   Start Trial INDICATED FOR THE TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) IN COMBINATION WITH CHEMOTHERAPY
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-001 Jun 28, 2006 RX Yes No   Start Trial INDICATED FOR THE TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) IN COMBINATION WITH CHEMOTHERAPY
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-006 Oct 28, 2010 RX Yes No   Start Trial INDICATED FOR THE TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) IN COMBINATION WITH CHEMOTHERAPY
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-002 Jun 28, 2006 RX Yes No   Start Trial INDICATED FOR THE TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) IN COMBINATION WITH CHEMOTHERAPY
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-003 Jun 28, 2006 RX Yes No   Start Trial INDICATED FOR THE TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) IN COMBINATION WITH CHEMOTHERAPY
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Exclusivity Expiration >Patented / Exclusive Use

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