Generic Iclusig Availability
Last updated on Apr 10, 2025.
Iclusig is a brand name of ponatinib, approved by the FDA in the following formulation(s):
ICLUSIG (ponatinib hydrochloride - tablet;oral)
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Manufacturer: TAKEDA PHARMS USA
Approval date: December 14, 2012
Strength(s): EQ 15MG BASE [RLD], EQ 45MG BASE [RLD] -
Manufacturer: TAKEDA PHARMS USA
Approval date: April 23, 2015
Strength(s): EQ 30MG BASE [RLD] -
Manufacturer: TAKEDA PHARMS USA
Approval date: December 18, 2020
Strength(s): EQ 10MG BASE [RLD]
Is there a generic version of Iclusig available?
No. There is currently no therapeutically equivalent version of Iclusig available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Iclusig. 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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Crystalline forms of 3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-n-{4-[(4-methylpiperazin-1-yl)methyl]-3-(trifluoromethyl)phenyl}benzamide and its mono hydrochloride salt
Patent 11,192,895
Issued: December 7, 2021
Inventor(s): Murray Christopher K. & Rozamus Leonard W. & Chaber John J. & Sharma Pradeep K.
Assignee(s): ARIAD PHARMACEUTICALS, INC.Novel crystalline forms of 3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-{4-[(4-methylpiperazin-1-yl)methyl]-3-(trifluoromethyl)phenyl}benzamide free base and 3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-{4-[(4-methylpiperazin-1-yl)methyl]-3-(trifluoromethyl)phenyl}benzamide mono hydrochloride, pharmaceutical compositions thereof and methods of their preparation and use are disclosed herein.
Patent expiration dates:
- December 12, 2033✓
- December 12, 2033✓
- December 12, 2033✓
- December 12, 2033
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Crystalline forms of 3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-{4-[(4-methylpiperazin-1-yl)methyl]-3-(trifluoromethyl)phenyl}benzamide and its mono hydrochloride salt
Patent 11,192,897
Issued: December 7, 2021
Inventor(s): Murray Christopher K. & Rozamus Leonard W. & Chaber John J. & Sharma Pradeep K.
Assignee(s): ARIAD PHARMACEUTICALS, INC.Novel crystalline forms of 3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-{4-[(4-methylpiperazin-1-yl)methyl]-3-(trifluoromethyl)phenyl}benzamide free base and 3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-{4-[(4-methylpiperazin-1-yl)methyl]-3-(trifluoromethyl)phenyl}benzamide mono hydrochloride, pharmaceutical compositions thereof and methods of their preparation and use are disclosed herein.
Patent expiration dates:
- December 12, 2033✓✓
- December 12, 2033✓✓
- December 12, 2033✓✓
- December 12, 2033
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Crystalline forms of 3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-n-{4-[(4-methylpiperazin-1- yl)methyl]-3-(trifluoromethyl)phenyl}benzamide and its mono hydrochloride salt
Patent 11,384,086
Issued: July 12, 2022
Inventor(s): Murray; Christopher K. et al.
Assignee(s): ARIAD PHARMACEUTICALS, INC. (Cambridge, MA)Novel crystalline forms of 3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-{4-[(4-methylpiperazin-1-yl)methyl]-3-(trifluoromethyl)phenyl}benzamide free base and 3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-{4-[(4-methylpiperazin-1-yl)methyl]-3-(trifluoromethyl)phenyl}benzamide mono hydrochloride, pharmaceutical compositions thereof and methods of their preparation and use are disclosed herein.
Patent expiration dates:
- December 12, 2033✓✓✓
- December 12, 2033✓✓✓
- December 12, 2033✓✓✓
- December 12, 2033
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Substituted acetylenic imidazo[1,2-B]pyridazine compounds as kinase inhibitors
Patent 8,114,874
Issued: February 14, 2012
Inventor(s): Zou Dong & Huang Wei-Sheng & Thomas R. Mathew & Romero Jan Antionette C. & Qi Jiwei & Wang Yihan & Zhu Xiaotian & Shakespeare William C. & Sundaramoorthi Rajeswari & Metcalf & III Chester A. & Dalgarno David C. & Sawyer Tomi K.
Assignee(s): ARIAD Pharmaceuticals, Inc.This invention relates to compounds of the general formula:
Patent expiration dates:
- January 24, 2027✓✓
- January 24, 2027
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Substituted acetylenic imidazo[1,2-A]pyridazines as kinase inhibitors
Patent 9,029,533
Issued: May 12, 2015
Inventor(s): Zou Dong & Huang Wei-Sheng & Thomas R. Mathew & Romero Jan Antoinette C. & Qi Jiwei & Wang Yihan & Zhu Xiaotian & Shakespeare William C. & Sundaramoorthi Rajeswari & Metcalf & III Chester A. & Dalgarno David C. & Sawyer Tomi K.
Assignee(s): ARIAD Pharmaceuticals, Inc.This invention relates to compounds of the general formula:
Patent expiration dates:
- December 22, 2026✓
- December 22, 2026✓
- December 22, 2026✓
- December 22, 2026✓
- December 22, 2026✓
- December 22, 2026
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Crystalline forms of 3-(imidazo[1,2-B] pyridazin-3-ylethynyl)-4-methyl-N-{4-[(4-methylpiperazin-1-yl) methyl]-3-(trifluoromethyl)phenyl}benzamide and its mono hydrochloride salt
Patent 9,493,470
Issued: November 15, 2016
Inventor(s): Murray Christopher K. & Rozamus Leonard W. & Chaber John J. & Sharma Pradeep
Assignee(s): ARIAD PHARMACEUTICALS, INC.Novel crystalline forms of 3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyi-N-{4-[(4-methylpiperazin-1-yl)methyl]-3-(trifluoromethyl)phenyljbenzamide free base and 3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyi-N-{4-[(4-methyl piperazin-1-yl)methyl]-3-(trifluoromethyl)phenyl}benzamide mono hydrochloride, pharmaceutical compositions thereof and methods of their preparation and use are disclosed herein. The instant application is directed to novel crystalline forms of 3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyi-N-{4-[(4-methylpiperazin-1-yl)methyl]-3-(trifluoromethyl}phenyl}benzamide and 3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyi-N-{4-[(4-methylpiperazin-1-yl)methyl]-3-(trifluoromethyl)phenyl}benzamide mono hydrochloride, compositions comprising such crystalline forms, and to methods of their preparation and use.
Patent expiration dates:
- December 12, 2033✓✓✓
- December 12, 2033✓✓✓
- December 12, 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:
- March 19, 2027 - TREATMENT OF ADULT PATIENTS WITH NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (PH+ ALL) IN COMBINATION WITH CHEMOTHERAPY
- March 19, 2031 - TREATMENT OF ADULT PATIENTS WITH NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (PH+ ALL)
More about Iclusig (ponatinib)
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- Drug class: BCR-ABL tyrosine kinase 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
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
