Generic Xalkori Availability

Xalkori is a brand name of crizotinib, approved by the FDA in the following formulation(s):

XALKORI (crizotinib - capsule;oral)

  • Manufacturer: PF PRISM CV
    Approval date: August 26, 2011
    Strength(s): 200MG, 250MG [RLD]

Has a generic version of Xalkori been approved?

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: About generic drugs.

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.

  • Aminoheteroaryl compounds as protein kinase inhibitors
    Patent 7,230,098
    Issued: June 12, 2007
    Inventor(s): Cui; Jingrong Jean & Bhumralkar; Dilip & Botrous; Iriny & Chu; Ji Yu & Funk; Lee A. & Hanau; Cathleen Elizabeth & Harris; G. Davis & Jia; Lei & Johnson; Joanne & Kolodziej; Stephen A. & Kung; Pei-Pei & Li; Xiaoyuan (Sharon) & Lin; Jason (Qishen) & Meng; Jerry Jialun & Nambu; Mitchel
    Assignee(s): Sugen, Inc.
    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
    Patent expiration dates:
    • March 1, 2025
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      Drug substance
  • Method of treating abnormal cell growth
    Patent 7,825,137
    Issued: November 2, 2010
    Inventor(s): Christensen; James Gail & Zou; Yahong
    Assignee(s): Pfizer Inc.
    The present invention relates to the use of (R)-3-[1-(2,6-Dichloro-3-fluoro-phenyl)-ethoxy]-5-(1-piperidin-4-yl-1H-pyrazol-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
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      Patent use: TREATMENT OF A CANCER MEDIATED BY AN ANAPLASTIC LYMPHOMA KINASE (ALK)
  • Enantiomerically pure aminoheteroaryl compounds as protein kinase inhibitors
    Patent 7,858,643
    Issued: December 28, 2010
    Inventor(s): Cui; Jingrong Jean & Funk; Lee Andrew & Jia; Lei & Kung; Pei-Pei & Meng; Jerry Jialun & Nambu; Mitchell David & Pairish; Mason Alan & Shen; Hong & Tran-Dube; Michelle
    Assignee(s): Agouron Pharmaceuticals, Inc.
    Enantiomerically pure compound of formula 1 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
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      Drug substance
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      Drug product
  • 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
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      Drug substance
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      Drug product

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:
    • August 26, 2016 -
    • August 26, 2018 -

Glossary

TermDefinition
Drug PatentA 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 ExclusivityExclusivity 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.
RLDA 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.
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