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Generic Zykadia Availability

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

ZYKADIA (ceritinib - capsule;oral)

  • Manufacturer: NOVARTIS PHARMS CORP
    Approval date: April 29, 2014
    Strength(s): 150MG [RLD]

Has a generic version of Zykadia been approved?

No. There is currently no therapeutically equivalent version of Zykadia available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Zykadia. 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.

  • Pyrimidine compounds
    Patent 7,153,964
    Issued: December 26, 2006
    Inventor(s): Pease; Elizabeth Janet & Breault; Gloria Anne & Morris; Jeffrey James
    Assignee(s): AstraZeneca AB
    Pyrimidine derivatives of formula (I) wherein: Qh1 and Q2 are independently selected from aryl or carbon linked heteroaryl optionally substituted as defined within; and one of Q1 and Q2 or both Q1 and Q2 is substituted on a ring carbon by one group selected from sulphamoyl, N—(C1-4alkyl)sulphamoyl (optionally substituted by halo or hydroxy), N,N-di-(C1-4alkyl)sulphamoyl (optionally substituted by halo or hydroxy), C1-4alkylsulphonyl (optionally substituted by halo or hydroxy) or a substituent of the formula (Ia) or (Ia′): wherein Q1, Q2, G, R1, Y, Z, Q3, n and m are as defined within; and pharmaceutically acceptable salts and in vivo hydrolysable esters thereof are described. Processes for their manufacture, pharmaceutical compositions and their use as cyclin-dependent serine/threonine kinase (CDK) inhibitors are also described
    Patent expiration dates:
    • February 26, 2021
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  • 2, 4-pyrimidinediamines useful in the treatment of neoplastic diseases, inflammatory and immune system disorders
    Patent 7,893,074
    Issued: February 22, 2011
    Inventor(s): Garcia-Echeverria; Carlos & Kanazawa; Takanori & Kawahara; Eiji & Masuya; Keiichi & Matsuura; Naoko & Miyake; Takahiro & Ohmori; Osamu & Umemura; Ichiro & Steensma; Ruo & Chopiuk; Greg & Jiang; Jiqing & Wan; Yongqin & Ding; Qiang & Zhang; Qiong & Gray; Nathanael Schiander & Karanewsky
    Assignee(s): Novartis AG IRM LLC
    Novel pyrimidine derivatives of formula I to processes for their production, their use as pharmaceuticals and to pharmaceutical compositions comprising them.
    Patent expiration dates:
    • April 25, 2026
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  • 2,4-di (phenylamino) pyrimidines useful in the treatment of neoplastic diseases, inflammatory and immune system disorders
    Patent 7,964,592
    Issued: June 21, 2011
    Inventor(s): Garcia-Echeverria; Carlos & Kanazawa; Takanori & Kawahara; Eiji & Masuya; Keiichi & Matsuura; Naoko & Miyake; Takahiro & Ohmori; Osamu & Umemura; Ichiro
    Assignee(s): Novartis AG
    Novel pyrimidine derivatives of formula I to process for their production, their use as pharmaceuticals and to pharmaceutical compositions comprising them.
    Patent expiration dates:
    • January 13, 2027
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  • Compounds and compositions as protein kinase inhibitors
    Patent 8,039,479
    Issued: October 18, 2011
    Inventor(s): Michellys; Pierre-Yves & Pei; Wei & Marsilje; Thomas H. & Chen; Bei & Uno; Tetsuo
    Assignee(s): IRM LLC
    The invention provides novel pyrimidine and pyridine derivatives and pharmaceutical compositions thereof, and methods for using such compounds. For example, the pyrimidine and pyridine derivatives of the invention may be used to treat, ameliorate or prevent a condition which responds to inhibition of anaplastic lymphoma kinase (ALK) activity, focal adhesion kinase (FAK), zeta-chain-associated protein kinase 70 (ZAP-70), insulin-like growth factor (IGF-1R), or a combination thereof.
    Patent expiration dates:
    • June 29, 2030
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  • Compounds and compositions as protein kinase inhibitors
    Patent 8,377,921
    Issued: February 19, 2013
    Assignee(s): IRM LLC
    The invention provides novel pyrimidine and pyridine derivatives and pharmaceutical compositions thereof, and methods for using such compounds. For example, the pyrimidine and pyridine derivatives of the invention may be used to treat, ameliorate or prevent a condition which responds to inhibition of anaplastic lymphoma kinase (ALK) activity, focal adhesion kinase (FAK), zeta-chain-associated protein kinase 70 (ZAP-70), insulin-like growth factor (IGF-1R), or a combination thereof.
    Patent expiration dates:
    • November 20, 2027
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      Patent use: TREATMENT OF A CANCER MEDIATED BY AN ANAPLASTIC LYMPHOMA KINASE (ALK)
  • Methods of using ALK inhibitors
    Patent 8,703,787
    Issued: April 22, 2014
    Assignee(s): IRM LLC
    The invention provides methods for using compounds of Formula (I) for treating an EML4-ALK+ mediated condition such as EML4-ALK+ non-small cell lung cancer, and optionally resistant to crizotinib; wherein R1, R2, R3, R4, R5 and R6 are as defined above.
    Patent expiration dates:
    • February 2, 2032
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      Patent use: TREATMENT OF A CANCER MEDIATED BY AN ANAPLASTIC LYMPHOMA KINASE (ALK)
  • Crystalline forms of 5-chloro-N2-(2-isopropoxy-5-methyl-4-piperidin-4-yl-phenyl)-N4-[2-(propane-2-sulfonyl)-phenyl]-pyrimidine-2, 4-diamine
    Patent 9,309,229
    Issued: April 12, 2016
    Assignee(s): Novartis AG
    The present invention describes specific crystalline forms of 5-chloro-N-(2-isopropoxy-5-methyl-4-(piperidin-4-ylphenyl)-N-2-(isopropylsulfonyl)phenyl)-2,4-diamine. The present invention further relates to methods for preparing said crystalline forms, pharmaceutical compositions comprising said crystalline forms, and methods of using said crystalline forms and pharmaceutical compositions to treat disease.
    Patent expiration dates:
    • January 18, 2032
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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:
    • April 29, 2019 - NEW CHEMICAL ENTITY
    • April 29, 2021 - ORPHAN DRUG EXCLUSIVITY

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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