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Generic Sprycel Availability

Last updated on Nov 9, 2021.

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

SPRYCEL (dasatinib - tablet;oral)

Has a generic version of Sprycel been approved?

No. There is currently no therapeutically equivalent version of Sprycel available in the United States.

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 & 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
    • September 28, 2026
      ✓ 
      Pediatric exclusivity
  • Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors
    Patent 8,680,103
    Issued: March 25, 2014
    Assignee(s): Bristol-Myers Squibb Company

    The invention relates to a pharmaceutical composition of a crystalline monohydrate of the compound of formula (IV) wherein the crystalline monohydrate is characterized by certain unit cell parameters.

    Patent expiration dates:

    • February 4, 2025
      ✓ 
      Drug product
    • 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:

    • May 9, 2021 - PEDIATRIC EXCLUSIVITY
    • December 21, 2021 - TREATMENT OF PEDIATRIC PATIENTS ONE YEAR OF AGE AND OLDER WITH NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME-POSITIVE (PH+) ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) IN COMBINATION WITH CHEMOTHERAPY
    • June 21, 2022 - PEDIATRIC EXCLUSIVITY
    • November 9, 2024 -
    • May 9, 2025 - PEDIATRIC EXCLUSIVITY
    • December 21, 2025 -
    • June 21, 2026 - PEDIATRIC EXCLUSIVITY

Glossary

Term Definition
Drug Patent A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug Exclusivity Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLD A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.

Further information

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

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