Generic Gleevec Availability
Gleevec is a brand name of imatinib, approved by the FDA in the following formulation(s):
GLEEVEC (imatinib mesylate - tablet; oral)
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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.
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.
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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✓✓
- January 4, 2015✓✓✓
- January 4, 2015
- July 4, 2015✓
- January 4, 2015
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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✓✓✓
- November 23, 2019✓
- May 23, 2019
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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✓
- June 19, 2022✓
- December 19, 2021
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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✓✓✓
- July 16, 2019✓
- January 16, 2019
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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✓✓
- July 16, 2019✓
- January 16, 2019
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:
- October 19, 2013 - ORPHAN DRUG EXCLUSIVITY
- December 19, 2015 - ORPHAN DRUG EXCLUSIVITY
- 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 - ORPHAN DRUG EXCLUSIVITY
See also...
- Gleevec Consumer Information (Drugs.com)
- Gleevec Consumer Information (Wolters Kluwer)
- Gleevec Consumer Information (Cerner Multum)
- Gleevec Advanced Consumer Information (Micromedex)
- Gleevec AHFS DI Monographs (ASHP)
- Imatinib Consumer Information (Wolters Kluwer)
- Imatinib Consumer Information (Cerner Multum)
- Imatinib Advanced Consumer Information (Micromedex)
- Imatinib Mesylate AHFS DI Monographs (ASHP)
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. |
