Generic Ayvakit Availability
Last updated on Mar 13, 2025.
Ayvakit is a brand name of avapritinib, approved by the FDA in the following formulation(s):
AYVAKIT (avapritinib - tablet;oral)
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Manufacturer: BLUEPRINT MEDICINES
Approval date: January 9, 2020
Strength(s): 100MG [RLD], 200MG [RLD], 300MG [RLD] -
Manufacturer: BLUEPRINT MEDICINES
Approval date: June 16, 2021
Strength(s): 25MG [RLD], 50MG [RLD]
Has a generic version of Ayvakit been approved?
No. There is currently no therapeutically equivalent version of Ayvakit available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Ayvakit. 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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Patent 11,827,642
Patent expiration dates:
- October 15, 2034✓✓✓
- October 15, 2034
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Patent 11,964,980
Patent expiration dates:
- April 10, 2040✓✓
- April 10, 2040
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Patent 11,999,744
Patent expiration dates:
- April 10, 2040✓
- April 10, 2040✓
- April 10, 2040
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Patent 12,060,354
Patent expiration dates:
- March 8, 2042✓
- March 8, 2042
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Compositions useful for treating disorders related to KIT
Patent 9,200,002
Issued: December 1, 2015
Inventor(s): Hodous Brian L. & Kim Joseph L. & Wilson Kevin J. & Wilson Douglas & Zhang Yulian
Assignee(s): BLUEPRINT MEDICINES CORPORATIONCompounds and compositions useful for treating disorders related to mutant KIT are described herein.
Patent expiration dates:
- October 15, 2034✓✓✓
- October 15, 2034✓✓✓
- October 15, 2034✓✓✓
- October 15, 2034
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Compositions useful for treating disorders related to kit
Patent 9,944,651
Issued: April 17, 2018
Inventor(s): Hodous Brian L. & Kim Joseph L. & Wilson Kevin J. & Wilson Douglas & Zhang Yulian
Assignee(s): BLUEPRINT MEDICINES CORPORATIONCompounds and compositions useful for treating disorders related to mutant KIT are described herein.
Patent expiration dates:
- October 15, 2034✓✓✓
- October 15, 2034✓✓✓
- October 15, 2034✓✓✓
- October 15, 2034
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Compositions useful for treating disorders related to kit
Patent 9,994,575
Issued: June 12, 2018
Inventor(s): Hodous Brian L. & Kim Joseph L. & Wilson Kevin J. & Wilson Douglas & Zhang Yulian
Assignee(s): BLUEPRINT MEDICINES CORPORATIONCompounds and compositions useful for treating disorders related to mutant KIT are described herein.
Patent expiration dates:
- October 15, 2034✓✓✓
- October 15, 2034✓✓✓
- October 15, 2034✓✓✓
- October 15, 2034
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:
- January 9, 2025 - NEW CHEMICAL ENTITY
- May 22, 2026 - TREATMENT OF ADULT PATIENTS WITH INDOLENT SYSTEMIC MASTOCYTOSIS (ISM)
- January 9, 2027 - INDICATED FOR THE TREATMENT OF ADULTS WITH UNRESECTABLE OR METASTATIC GIST HARBORING A PLATELET-DERIVED GROWTH FACTOR RECEPTOR ALPHA (PDGFRA) EXON 18 MUTATION, INCLUDING PDGFRA D842V MUTATIONS
- June 16, 2028 - FOR THE TREATMENT OF ADULT PATIENTS WITH ADVANCED SYSTEMIC MASTOCYTOSIS (ADVSM). ADVSM INCLUDES PATIENTS WITH AGGRESSIVE SYSTEMIC MASTOCYTOSIS (ASM), SYSTEMIC MASTOCYTOSIS WITH AN ASSOCIATED HEMATOLOGICAL NEOPLASM (SM-AHN), AND MAST CELL LEUKEMIA (MCL)
- May 22, 2030 - TREATMENT OF ADULT PATIENTS WITH INDOLENT SYSTEMIC MASTOCYTOSIS (ISM)
More about Ayvakit (avapritinib)
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- During pregnancy
- FDA approval history
- Drug class: multikinase inhibitors
- Breastfeeding
- En español
Patient resources
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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. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
