Generic Xalkori Availability
Last updated on Apr 10, 2025.
Xalkori is a brand name of crizotinib, approved by the FDA in the following formulation(s):
XALKORI (crizotinib - capsule, pellets;oral)
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Manufacturer: PF PRISM CV
Approval date: September 7, 2023
Strength(s): 20MG [RLD], 50MG [RLD], 150MG [RLD]
XALKORI (crizotinib - capsule;oral)
Is there a generic version of Xalkori available?
No. There is currently no therapeutically equivalent version of Xalkori available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Xalkori. 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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Aminoheteroaryl compounds as protein kinase inhibitors
Patent 7,230,098
Issued: June 12, 2007
Inventor(s): Cui; Jingrong Jean et al.
Assignee(s): Sugen, Inc. (South San Francisco, CA)Aminopyridine and aminopyrazine compounds of formula (1), compositions including these compounds, and methods of their use are provided. Preferred compounds of formula 1 have activity as protein kinase inhibitors, including as inhibitors of c-MET ##STR00001##
Patent expiration dates:
- August 26, 2025✓
- August 26, 2025
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Method of treating abnormal cell growth
Patent 7,825,137
Issued: November 2, 2010
Inventor(s): Christensen; James Gail et al.
Assignee(s): Pfizer Inc. (New York, NY)The present invention relates to the use of (R)-3-[1-(2,6-Dichloro-3-fluoro-phenyl)-ethoxy]-5-(1-piperidin-4-yl-1H-py- razol-4-yl)-pyridin-2-ylamine, a novel c-Met/HGFR inhibitor, for treating abnormal cell growth in mammals. In particular, the invention provides methods of treating mammals suffering from cancer.
Patent expiration dates:
- May 12, 2027✓
- May 12, 2027✓
- May 12, 2027✓
- May 12, 2027
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Enantiomerically pure aminoheteroaryl compounds as protein kinase inhibitors
Patent 7,858,643
Issued: December 28, 2010
Inventor(s): Cui; Jingrong Jean et al.
Assignee(s): Agouron Pharmaceuticals, Inc. (San Diego, CA)Enantiomerically pure compound of formula 1 ##STR00001## are provided, as well as methods for their synthesis and use. Preferred compounds are potent inhibitors of the c-Met protein kinase, and are useful in the treatment of abnormal cell growth disorders, such as cancers.
Patent expiration dates:
- October 8, 2029✓✓
- October 8, 2029
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Polymorphs of a c-MET/HGFR inhibitor
Patent 8,217,057
Issued: July 10, 2012
Inventor(s): Cui Jingrong Jean & Tran-Dubé Michelle Bich
Assignee(s): Pfizer Inc.This invention relates to polymorphs of (R)-3-[1-(2,6-Dichloro-3-fluoro-phenyl)-ethoxy]-5-(1-piperidin-4-yl-1H-pyrazol-4-yl)-pyridin-2-ylamine that are useful in the treatment of abnormal cell growth, such as cancer, in mammals. This invention also relates to compositions including such salts and polymorphs, and to methods of using such compositions in the treatment of abnormal cell growth in mammals, especially humans.
Patent expiration dates:
- November 6, 2029✓
- November 6, 2029✓✓
- November 6, 2029
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Enantiomerically pure aminoheteroaryl compounds as protein kinase inhibitors
Patent 8,785,632
Issued: July 22, 2014
Inventor(s): Cui; Jingrong Jean et al.
Assignee(s): Agouron Pharmaceuticals, Inc. (San Diego, CA); Pfizer Inc. (New York, NY)Enantiomerically pure compound of formula 1 ##STR00001## are provided, as well as methods for their synthesis and use. Preferred compounds are potent inhibitors of the c-Met protein kinase, and are useful in the treatment of abnormal cell growth disorders, such as cancers.
Patent expiration dates:
- March 1, 2025✓✓
- March 1, 2025✓
- March 1, 2025
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:
- July 14, 2025 - TREATMENT OF ADULT AND PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH UNRESECTABLE, RECURRENT OR REFRACTORY INFLAMMATORY MYOFIBROBLASTIC TUMOR (IMT) THAT IS ANAPLASTIC LYMPHOMA KINASE (ALK) POSITIVE
- January 14, 2028 - TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER AND YOUNG ADULTS WITH RELAPSED OR REFRACTORY, SYSTEMIC ANAPLASTIC LARGE CELL LYMPHOMA (ALCL) THAT IS ALK-POSITIVE
- July 14, 2029 - TREATMENT OF ADULT AND PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH UNRESECTABLE, RECURRENT, OR REFRACTORY INFLAMMATORY MYOFIBROBLASTIC TUMOR (IMT) THAT IS ALK-POSITIVE
More about Xalkori (crizotinib)
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- 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
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
