Details for New Drug Application (NDA): 021986

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NDA 021986 describes SPRYCEL, which is a drug marketed by Bristol Myers Squibb and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug and three Paragraph IV challenges. Additional details are available on the SPRYCEL profile page.

The generic ingredient in SPRYCEL is dasatinib. There are fourteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the dasatinib profile page.

Summary for 021986

Tradename:	SPRYCEL
Applicant:	Bristol Myers Squibb
Ingredient:	dasatinib
Patents:	2

Pharmacology for NDA: 021986

Mechanism of Action	Cytochrome P450 3A4 Inhibitors Protein Kinase Inhibitors

Medical Subject Heading (MeSH) Categories for 021986

Antineoplastic Agents
Protein Kinase Inhibitors

Suppliers and Packaging for NDA: 021986

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SPRYCEL	dasatinib	TABLET;ORAL	021986	NDA	E.R. Squibb & Sons, L.L.C.	0003-0524	0003-0524-11	1 BOTTLE in 1 CARTON (0003-0524-11) / 60 TABLET in 1 BOTTLE
SPRYCEL	dasatinib	TABLET;ORAL	021986	NDA	E.R. Squibb & Sons, L.L.C.	0003-0527	0003-0527-11	1 BOTTLE in 1 CARTON (0003-0527-11) / 60 TABLET in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Jun 28, 2006	TE:	AB	RLD:	Yes
Regulatory Exclusivity Expiration:	Dec 21, 2025
Regulatory Exclusivity Use:	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
Regulatory Exclusivity Expiration:	Jun 21, 2026
Regulatory Exclusivity Use:	PEDIATRIC EXCLUSIVITY
Regulatory Exclusivity Expiration:	May 9, 2025
Regulatory Exclusivity Use:	PEDIATRIC EXCLUSIVITY

Expired US Patents for NDA 021986

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-006	Oct 28, 2010	7,153,856*PED	⤷ Subscribe
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-003	Jun 28, 2006	6,596,746*PED	⤷ Subscribe
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-003	Jun 28, 2006	7,153,856*PED	⤷ Subscribe
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-004	May 30, 2008	6,596,746*PED	⤷ Subscribe
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-004	May 30, 2008	7,125,875*PED	⤷ Subscribe
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