Generic Ibtrozi Availability
Last updated on Jul 9, 2025.
Ibtrozi is a brand name of taletrectinib, approved by the FDA in the following formulation(s):
IBTROZI (taletrectinib adipate - capsule;oral)
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Manufacturer: NUVATION
Approval date: June 11, 2025
Strength(s): EQ 200MG BASE [RLD]
Is there a generic version of Ibtrozi available?
No. There is currently no therapeutically equivalent version of Ibtrozi available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Ibtrozi. 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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Imidazo[1,2-b]pyridazine derivatives as kinase inhibitors
Patent 9,187,489
Issued: November 17, 2015
Inventor(s): Takeda; Yasuyuki et al.
Assignee(s): Daiichi Sankyo Company, Limited (Chuo-ku, JP)The present invention is intended to provide a compound or a pharmacologically acceptable salt thereof which is useful in the treatment of a tumor through its ROS1 kinase enzyme activity inhibitory effect and NTRK kinase enzyme inhibitory effect. The present invention provides a compound having an imidazo[1,2-b]pyridazine structure represented by the general formula (I) or a pharmacologically acceptable salt thereof, and a pharmaceutical composition comprising the compound. In the formula, R.sup.1, G, T, Y.sup.1, Y.sup.2, Y.sup.3, and Y.sup.4 are as defined herein.
Patent expiration dates:
- June 3, 2033✓✓✓
- June 3, 2033
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Imidazo[1,2-b]pyridazine derivatives as kinase inhibitors
Patent 9,751,887
Issued: September 5, 2017
Inventor(s): Takeda; Yasuyuki et al.
Assignee(s): Daiichi Sankyo Company, Limited (Chuo-ku, JP)The present invention is intended to provide a compound or a pharmacologically acceptable salt thereof which is useful in the treatment of a tumor through its ROS1 kinase enzyme activity inhibitory effect and NTRK kinase enzyme inhibitory effect. The present invention provides a compound having an imidazo[1,2-b]pyridazine structure represented by the general formula (I) or a pharmacologically acceptable salt thereof, and a pharmaceutical composition comprising the compound. In the formula, R.sup.1, G, T, Y.sup.1, Y.sup.2, Y.sup.3, and Y.sup.4 are as defined herein.
Patent expiration dates:
- June 3, 2033✓✓✓
- June 3, 2033
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:
- June 11, 2030 - NEW CHEMICAL ENTITY
More about Ibtrozi (taletrectinib)
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- FDA approval history
- Drug class: multikinase inhibitors
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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
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