Generic Gleevec Availability

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

GLEEVEC (imatinib mesylate - tablet;oral)

  • Manufacturer: NOVARTIS
    Approval date: April 18, 2003
    Strength(s): EQ 100MG BASE, EQ 400MG BASE [RLD]

Has a generic version of Gleevec been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Gleevec. 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 derivatives and processes for the preparation thereof
    Patent 5,521,184
    Issued: May 28, 1996
    Inventor(s): Zimmermann; Jurg
    Assignee(s): Ciba-Geigy Corporation
    There are described N-phenyl-2-pyrimidine-amine derivatives of formula I ##STR1## wherein R.sub.1 is 4-pyrazinyl, 1-methyl-1H-pyrrolyl, amino- or amino-lower alkyl-substituted phenyl wherein the amino group in each case is free, alkylated or acylated, 1H-indolyl or 1H-imidazolyl bonded at a five-membered ring carbon atom, or unsubstituted or lower alkyl-substituted pyridyl bonded at a ring carbon atom and unsubstituted or substituted at the nitrogen atom by oxygen, R.sup.2, R.sup.3, R.sup.9, X, Y, n and R.sup.10 are defined in claim 1 These compounds can be used, for example, in the therapy of tumoral diseases.
    Patent expiration dates:
    • January 4, 2015
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      Patent use: A METHOD FOR TREATING A TUMOR DISEASE
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      Drug substance
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      Drug product
    • January 4, 2015
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      Drug substance
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      Drug product
    • January 4, 2015
    • July 4, 2015
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      Pediatric exclusivity
  • Crystal modification of a N-phenyl-2-pyrimidineamine derivative, processes for its manufacture and its use
    Patent 6,894,051
    Issued: May 17, 2005
    Inventor(s): Zimmermann; Jürg & Sutter; Bertrand & Bürger; Hans Michael
    Assignee(s): Novartis AG
    The invention relates to a new crystalline form of the methanesulfonic acid addition salt of 4-(4-methylpiperazin-1-ylmethyl)-N-[4-methyl-3-(4-pyridin-3-yl)pyrimidin-2-ylamino)phenyl]benzamide of formula 1, which may be used for example for tumor therapy.
    Patent expiration dates:
    • May 23, 2019
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      Patent use: A METHOD FOR TREATING A TUMOR DISEASE
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    • November 23, 2019
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      Pediatric exclusivity
  • Treatment of gastrointestinal stromal tumors
    Patent 6,958,335
    Issued: October 25, 2005
    Inventor(s): Buchdunger; Elisabeth & Capdeville; Renaud & Demetri; George Daniel & Dimitrijevic; Sasa & Druker; Brian Jay & Fletcher; Jonathan A. & Heinrich; Michael C. & Joensuu; Heikki & Silberman; Sandra Leta & Tuveson; David
    Assignee(s): Novartis AG Dana-Farber Cancer Institute, Inc. Oregon Health & Science University
    4-(4-methylpiperazin-1-ylmethyl)-N-[4-methyl-3-(4-pyridin-3-yl)pyrimidin-2-ylamino)phenyl]-benzamide of the formula I or a pharmaceutically acceptable salt thereof can be used in the treatment of gastrointestinal stromal tumours.
    Patent expiration dates:
    • December 19, 2021
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      Patent use: GLEEVEC IS ALSO INDICATED FOR THE TREATMENT OF PATIENTS WITH KIT (CD117) POSITIVE UNRESECTABLE AND/OR METASTATIC MALIGNANT GASTROINTESTINAL STROMAL TUMORS (GIST)
    • June 19, 2022
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  • Crystal modification of a N-phenyl-2-pyrimidineamine derivative, processes for its manufacture and its use
    Patent 7,544,799
    Issued: June 9, 2009
    Inventor(s): Zimmermann; Jürg & Sutter; Bertrand & Bürger; Hans M
    Assignee(s): Novartis AG
    The invention relates to a new crystalline form of the methanesulfonic acid addition salt of 4-(4-methylpiperazin-1-ylmethyl)-N-[4-methyl-3-(4-pyridin-3-yl)pyrimidin-2-ylamino)phenyl]-benzamide of formula 1, which may be used for example for tumour therapy.
    Patent expiration dates:
    • January 16, 2019
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      Drug substance
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      Sponsor has requested patent be delisted
    • July 16, 2019
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      Pediatric exclusivity
  • Crystal modification of a N-phenyl-2-pyrimidineamine derivative, processes for its manufacture and its use
    Patent RE43932
    Issued: January 15, 2013
    Assignee(s): Novartis AG
    The invention relates to a new crystalline form of the methanesulfonic acid addition salt of 4-(4-methylpiperazin-1-yl-methyl)-N-[4-methyl-3-(4-pyridin-3-yl)pyrimidin-2-ylamino)phenyl]-benzamide of formula I, which may be used for example for tumour therapy.
    Patent expiration dates:
    • January 16, 2019
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      Drug substance
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      Drug product
    • July 16, 2019
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      Pediatric exclusivity

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:
    • January 25, 2016 - TREATMENT OF PEDIATRIC PATIENTS WITH NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (PH+ALL) IN COMBINATION WITH CHEMOTHERAPY
    • January 25, 2020 -

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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