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Last Updated: November 8, 2024

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
Medical Subject Heading (MeSH) Categories for 021986
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:RXDosage:TABLET;ORALStrength20MG
Approval Date:Jun 28, 2006TE:ABRLD: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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-002 Jun 28, 2006 ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-006 Oct 28, 2010 ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-002 Jun 28, 2006 ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-001 Jun 28, 2006 ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-004 May 30, 2008 ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-004 May 30, 2008 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.