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Generic Sprycel Availability

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?

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 INC
    Approval date: June 10, 2016
    Strength(s): 20MG [AB], 50MG [AB], 70MG [AB], 100MG [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 FAQs.

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
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      Patent use: A METHOD FOR THE TREATMENT OF CANCER
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    • June 28, 2020
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      Patent use: A METHOD FOR THE TREATMENT OF A PROTEIN TYROSINE KINASE-ASSOCIATED DISORDER
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  • 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
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      Patent use: A METHOD FOR THE TREATMENT OF CANCER
    • April 13, 2020
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      Patent use: A METHOD FOR TREATMENT OF A CANCER, WHEREIN THE CANCER IS CHRONIC MYELOGENOUS LEUKEMIA
  • 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
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      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
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  • 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
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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, 2020 - NEW PATIENT POPULATION
    • November 9, 2024 -
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Glossary
TermDefinition
Drug PatentA 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 ExclusivityExclusivity 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.
RLDA 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.
ABProducts meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (i.e., identical active ingredients(s), dosage form, and route(s) of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (i.e., AB1, AB2, AB3, etc.). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.

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