Generic Krazati Availability
Last updated on Jan 8, 2025.
Krazati is a brand name of adagrasib, approved by the FDA in the following formulation(s):
KRAZATI (adagrasib - tablet;oral)
Has a generic version of Krazati been approved?
No. There is currently no therapeutically equivalent version of Krazati available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Krazati. 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.
-
KRas G12C inhibitors
Patent 10,689,377
Issued: June 23, 2020
Inventor(s): Blake James F. & Burgess Laurence E. & Chicarelli Mark Joseph & Christensen James Gail & Cook Adam & Fell Jay Bradford & Fischer John P. & Marx Matthew Arnold & Mejia Macedonio J. & Savechenkov Pavel & Vigers Guy P. A. & Smith Christopher Ronald & Rodriguez Martha E.The present invention relates to compounds that inhibit KRas G12C. In particular, the present invention relates to compounds that irreversibly inhibit the activity of KRas G12C, pharmaceutical compositions comprising the compounds and methods of use therefor.
Patent expiration dates:
- May 17, 2037✓✓✓
- May 17, 2037✓✓✓
- May 17, 2037
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:
- December 12, 2027 - NEW CHEMICAL ENTITY
- December 12, 2029 - TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED AT LEAST ONE PRIOR SYSTEMIC THERAPY
More about Krazati (adagrasib)
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- Drug class: miscellaneous antineoplastics
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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.
