Generic Sprycel Availability

Last updated on Jun 11, 2025.

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 ^{[RLD] [AB]}, 50MG ^{[RLD] [AB]}, 70MG ^{[RLD] [AB]}
• Manufacturer: BRISTOL MYERS SQUIBB
  Approval date: May 30, 2008
  Strength(s): 100MG ^{[RLD] [AB]}
• Manufacturer: BRISTOL MYERS SQUIBB
  Approval date: October 28, 2010
  Strength(s): 80MG ^{[RLD] [AB]}, 140MG ^{[RLD] [AB]}

Is there a generic version of Sprycel available?

A generic version of Sprycel has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Sprycel and have been approved by the FDA:

dasatinib tablet;oral

• Manufacturer: APOTEX
  Approval date: June 10, 2016
  Strength(s): 20MG ^[AB], 50MG ^[AB], 70MG ^[AB], 100MG ^[AB]
• Manufacturer: APOTEX
  Approval date: November 23, 2021
  Strength(s): 80MG ^[AB], 140MG ^[AB]
• Manufacturer: BIOCON PHARMA
  Approval date: March 3, 2025
  Strength(s): 20MG ^[AB], 50MG ^[AB], 70MG ^[AB], 80MG ^[AB], 100MG ^[AB], 140MG ^[AB]
• Manufacturer: DR REDDYS
  Approval date: March 3, 2025
  Strength(s): 80MG ^[AB], 100MG ^[AB], 140MG ^[AB], 20MG ^[AB], 50MG ^[AB], 70MG ^[AB]
• Manufacturer: EUGIA PHARMA
  Approval date: April 22, 2025
  Strength(s): 20MG ^[AB], 50MG ^[AB], 70MG ^[AB], 80MG ^[AB], 100MG ^[AB], 140MG ^[AB]
• Manufacturer: ZYDUS PHARMS
  Approval date: March 3, 2025
  Strength(s): 20MG ^[AB], 50MG ^[AB], 70MG ^[AB], 80MG ^[AB], 100MG ^[AB], 140MG ^[AB]

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: Generic Drug FAQ.

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.

• Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors
  Patent 7,491,725
  Issued: February 17, 2009
  Inventor(s): Lajeunesse; Jean et al.
  Assignee(s): Bristol-Myers Squibb Company (Princeton, NJ)
  

  The invention relates to processes for preparing compounds having the formula, ##STR00001## and crystalline forms thereof, wherein Ar is aryl or heteroaryl, L is an optional alkylene linker, and R.sub.2, R.sub.3, R.sub.4, and R.sub.5, 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
• Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors
  Patent 7491725*PED
  Issued: February 17, 2009
  Inventor(s): Lajeunesse; Jean et al.
  Assignee(s): Bristol-Myers Squibb Company (Princeton, NJ)
  

  The invention relates to processes for preparing compounds having the formula, ##STR00001## and crystalline forms thereof, wherein Ar is aryl or heteroaryl, L is an optional alkylene linker, and R.sub.2, R.sub.3, R.sub.4, and R.sub.5, 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:

  • September 28, 2026
    
    ✓ 
    Pediatric exclusivity
• Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors
  Patent 8,680,103
  Issued: March 25, 2014
  Inventor(s): Lajeunesse Jean & DiMarco John D. & Galella Michael & Chidambaram Ramakrishnan
  Assignee(s): Bristol-Myers Squibb Company
  

  The invention relates to a pharmaceutical composition of a crystalline monohydrate of the compound of formula (IV)

  Patent expiration dates:

  • February 4, 2025
    
    ✓ 
    Drug product
• Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors
  Patent 8680103*PED
  Issued: March 25, 2014
  Inventor(s): Lajeunesse Jean & DiMarco John D. & Galella Michael & Chidambaram Ramakrishnan
  Assignee(s): Bristol-Myers Squibb Company
  

  The invention relates to a pharmaceutical composition of a crystalline monohydrate of the compound of formula (IV)

  Patent expiration dates:

  • August 4, 2025
    
    ✓ 
    Pediatric exclusivity

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 9, 2024 - TREATMENT OF PEDIATRIC PATIENTS WITH PHILADELPHIA CHROMOSOME-POSITIVE (PH+) CHRONIC MYELOID LEUKEMIA (CML) IN CHRONIC PHASE
  • May 9, 2025 - PEDIATRIC EXCLUSIVITY
  • December 21, 2025 - 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
  • June 21, 2026 - PEDIATRIC EXCLUSIVITY

Related/similar drugs

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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