.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021986

« Back to Dashboard
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 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 six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the dasatinib profile page.

Summary for NDA: 021986

Tradename:
SPRYCEL
Applicant:
Bristol Myers Squibb
Ingredient:
dasatinib
Patents:5
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details

Pharmacology for NDA: 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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Jun 28, 2006TE:ABRLD:No
Patent:7,491,725Patent Expiration:Mar 28, 2026Product Flag?YSubstance Flag?YDelist Request?
Patent:8,680,103Patent Expiration:Feb 4, 2025Product Flag?YSubstance Flag?Delist Request?
Patent:6,596,746Patent Expiration:Jun 28, 2020Product Flag?YSubstance Flag?YDelist Request?
Patented Use:A METHOD FOR THE TREATMENT OF A PROTEIN TYROSINE KINASE-ASSOCIATED DISORDER


Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

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 verifification 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.

`abc