Generic Imkeldi Availability
Last updated on Apr 10, 2025.
Imkeldi is a brand name of imatinib, approved by the FDA in the following formulation(s):
IMKELDI (imatinib mesylate - solution;oral)
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Manufacturer: SHORLA ONCOLOGY
Approval date: November 22, 2024
Strength(s): EQ 80MG BASE/ML [RLD]
Is there a generic version of Imkeldi available?
No. There is currently no therapeutically equivalent version of Imkeldi available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Imkeldi. 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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Liquid dosage forms of Imatinib
Patent 11,957,681
Issued: April 16, 2024
Inventor(s): Mehta; Sandip et al.
Assignee(s): SHORLA PHARMA LIMITED (County Tipperary, IE)Imatinib is approved and marketed in solid oral dosage forms which may be dispersed in water or apple juice for patients having swallowing difficulty. Dispersion of Imatinib solid dosage forms in apple juice may increase palatability and patient compliance but apple juice may not be available all the time for administration. Further, dispersion of Imatinib solid oral dosage forms may not administer correct and consistent dose of medicine every time. The present invention therefore provides liquid dosage forms of Imatinib which correctly and consistently administers correct dose of drug to the patients.
Patent expiration dates:
- April 27, 2040✓
- April 27, 2040
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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.
