Thursday, October 13, 2016

Sprycel


Sprycel is a brand name of dasatinib, approved by the FDA in the following formulation(s):


SPRYCEL (dasatinib - tablet; oral)



  • Manufacturer: BRISTOL MYERS SQUIBB

    Approval date: June 28, 2006

    Strength(s): 20MG, 50MG, 70MG


  • Manufacturer: BRISTOL MYERS SQUIBB

    Approval date: May 30, 2008

    Strength(s): 100MG


  • Manufacturer: BRISTOL MYERS SQUIBB

    Approval date: October 28, 2010

    Strength(s): 140MG [RLD], 80MG

Has a generic version of Sprycel been approved?


No. There is currently no therapeutically equivalent version of Sprycel available.


Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Sprycel. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.




Related Patents


Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.




  • Cyclic protein tyrosine kinase inhibitors
    Patent 6,596,746
    Issued: July 22, 2003
    Inventor(s): Jagabandhu; Das & Ramesh; Padmanabha & Ping; Chen & Derek J.; Norris & Arthur M. P.; Doweyko & Joel C.; Barrish & John; Wityak
    Assignee(s): Bristol-Myers Squibb Company
    Novel cyclic compounds and salts thereof, pharmaceutical compositions containing such compounds, and methods of using such compounds in the treatment of protein tyrosine kinase-associated disorders such as immunologic and oncologic disorders.
    Patent expiration dates:

    • June 28, 2020
      ✓ 
      Patent use: A METHOD FOR THE TREATMENT OF A PROTEIN TYROSINE KINASE-ASSOCIATED DISORDER
      ✓ 
      Drug substance
      ✓ 
      Drug product


    • June 28, 2020
      ✓ 
      Patent use: A METHOD FOR THE TREATMENT OF CANCER
      ✓ 
      Drug substance
      ✓ 
      Drug product




  • Cyclic protein tyrosine kinase inhibitors
    Patent 7,125,875
    Issued: October 24, 2006
    Inventor(s): Das; Jagabandhu & Padmanabha; Ramesh & Chen; Ping & Norris; Derek J. & Doweyko; Arthur M. P. & Barrish; Joel C. & Wityak; John & Lombardo; Louis J. & Lee; Francis Y. F.
    Assignee(s): Bristol-Myers Squibb Company
    Novel cyclic compounds and salts thereof, pharmaceutical compositions containing such compounds, and methods of using such compounds in the treatment of protein tyrosine kinase-associated disorders such as immunologic and oncologic disorders.
    Patent expiration dates:

    • April 13, 2020
      ✓ 
      Patent use: A METHOD FOR TREATMENT OF A CANCER, WHEREIN THE CANCER IS CHRONIC MYELOGENOUS LEUKEMIA


    • April 13, 2020
      ✓ 
      Patent use: A METHOD FOR THE TREATMENT OF CANCER




  • Cyclic protein tyrosine kinase inhibitors
    Patent 7,153,856
    Issued: December 26, 2006
    Inventor(s): Barrish; Joel C. & Wityak; John & Das; Jagabandhu & Chen; Ping & Norris; Derek J. & Schieven; Gary
    Assignee(s): Bristol-Myers Squibb Company
    Novel cyclic compounds and salts thereof, pharmaceutical compositions containing such compounds, and methods of using such compounds in the treatment of protein tyrosine kinase-associated disorders such as immunologic and oncologic disorders.
    Patent expiration dates:

    • April 28, 2020
      ✓ 
      Patent use: A METHOD FOR THE TREATMENT OF CANCER




  • Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors
    Patent 7,491,725
    Issued: February 17, 2009
    Inventor(s): Lajeunesse; Jean & DiMarco; John D. & Galella; Michael & Chidambaram; Ramakrishnan
    Assignee(s): Bristol-Myers Squibb Company
    The invention relates to processes for preparing compounds having the formula, and crystalline forms thereof, wherein Ar is aryl or heteroaryl, L is an optional alkylene linker, and R2, R3, R4, and R5, are as defined in the specification herein, which compounds are useful as kinase inhibitors, in particular, inhibitors of protein tyrosine kinase and p38 kinase.
    Patent expiration dates:

    • March 28, 2026
      ✓ 
      Drug substance
      ✓ 
      Drug product



Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:
    • November 6, 2010 - PROVIDE FOR THE USE OF A LOWER DOSE FOR THE TREATMENT OF ADULTS WITH CHRONIC PHASE CHRONIC MYELOID LEUKEMIA (CML) WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY INCLUDING IMATINIB MESYLATE

    • November 6, 2010 - PROVISION OF INFORMATION OF THE RESULTS OF A PHASE 2 RANDOMIZED TRIAL OF SPRYCEL 70MG TWICE DAILY OR IMATINIB 800MG DAILY

    • June 28, 2011 - NEW CHEMICAL ENTITY

    • May 21, 2012 - DOSING REGIMEN ADJUSTMENTS

    • June 28, 2013 - ORPHAN DRUG EXCLUSIVITY

    • October 28, 2013 - INFO ADDED TO LABEL RELATED TO NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME POSITIVE (PH+) CHRONIC MYELOID LEUKEMIA IC CHRONIC PHASE

See also...

  • Sprycel Consumer Information (Drugs.com)
  • Sprycel Consumer Information (Wolters Kluwer)
  • Sprycel Consumer Information (Cerner Multum)
  • Sprycel Advanced Consumer Information (Micromedex)
  • Sprycel AHFS DI Monographs (ASHP)
  • Dasatinib Consumer Information (Wolters Kluwer)
  • Consumer Information (Cerner Multum)
  • Dasatinib Consumer Information (Cerner Multum)
  • Dasatinib Advanced Consumer Information (Micromedex)
  • Dasatinib AHFS DI Monographs (ASHP)

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