Generic Sprycel Availability
Last updated on Jul 9, 2025.
Sprycel is a brand name of dasatinib, approved by the FDA in the following formulation(s):
SPRYCEL (dasatinib - tablet;oral)
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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
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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): 20MG [AB], 50MG [AB], 70MG [AB], 80MG [AB], 100MG [AB], 140MG [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.
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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✓✓
- March 28, 2026
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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✓
- September 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
Inventor(s): Lajeunesse Jean & DiMarco John D. & Galella Michael & Chidambaram Ramakrishnan
Assignee(s): Bristol-Myers Squibb CompanyThe invention relates to a pharmaceutical composition of a crystalline monohydrate of the compound of formula (IV)
Patent expiration dates:
- February 4, 2025✓
- February 4, 2025
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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 CompanyThe invention relates to a pharmaceutical composition of a crystalline monohydrate of the compound of formula (IV)
Patent expiration dates:
- August 4, 2025✓
- August 4, 2025
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
More about Sprycel (dasatinib)
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- During pregnancy
- FDA approval history
- Drug class: BCR-ABL tyrosine kinase inhibitors
- Breastfeeding
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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. |
| AB | Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes 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 (e.g. AB1, AB2, AB7). 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. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
