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Queensland Health
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Julphar
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Cipla
Merck
Cantor Fitzgerald
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Generated: April 22, 2018

DrugPatentWatch Database Preview

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 one supplier. There are five 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. One supplier is 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:5
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details
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 N 0003-0524-11
SPRYCEL dasatinib TABLET;ORAL 021986 NDA E.R. Squibb & Sons, L.L.C. 0003-0527 N 0003-0527-11

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Jun 28, 2006TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Nov 9, 2020
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Nov 9, 2024
Regulatory Exclusivity Use:TREATMENT OF PEDIATRIC PATIENTS WITH PHILADELPHIA CHROMOSOME-POSITIVE (PH+) CHRONIC MYELOID LEUKEMIA (CML) IN CHRONIC PHASE
Patent:➤ Sign UpPatent Expiration:Jun 28, 2020Product Flag?YSubstance Flag?YDelist Request?
Patented Use:A METHOD FOR THE TREATMENT OF A PROTEIN TYROSINE KINASE-ASSOCIATED DISORDER

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Baxter
US Army
Farmers Insurance
QuintilesIMS
Dow
Deloitte
Medtronic
Chubb

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