Gleevec is a drug owned by Novartis Pharmaceuticals Corp. It is protected by 10 US drug patents filed from 2013 to 2014 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 19, 2022. Details of Gleevec's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| USRE43932 | Crystal modification of a N-phenyl-2-pyrimidineamine derivative, processes for its manufacture and its use |
Jul, 2018
(6 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US6958335 (Pediatric) | Treatment of gastrointestinal stromal tumors |
Jun, 2022
(2 years ago) |
Expired
|
| US6958335 | Treatment of gastrointestinal stromal tumors |
Dec, 2021
(2 years ago) |
Expired
|
|
US6894051 (Pediatric) | Crystal modification of a N-phenyl-2-pyrimidineamine derivative, processes for its manufacture and its use |
Nov, 2019
(4 years ago) |
Expired
|
|
USRE43932 (Pediatric) | Crystal modification of a N-phenyl-2-pyrimidineamine derivative, processes for its manufacture and its use |
Jan, 2019
(5 years ago) |
Expired
|
|
US7544799 (Pediatric) | Crystal modification of a N-phenyl-2-pyrimidineamine derivative, processes for its manufacture and its use |
Jul, 2019
(5 years ago) |
Expired
|
| US6894051 | Crystal modification of a N-phenyl-2-pyrimidineamine derivative, processes for its manufacture and its use |
May, 2019
(5 years ago) |
Expired
|
| US7544799 | Crystal modification of a N-phenyl-2-pyrimidineamine derivative, processes for its manufacture and its use |
Jan, 2019
(5 years ago) |
Expired
|
| USRE43932 | Crystal modification of a N-phenyl-2-pyrimidineamine derivative, processes for its manufacture and its use |
Jan, 2019
(5 years ago) |
Expired
|
|
US5521184 (Pediatric) | Pyrimidine derivatives and processes for the preparation thereof |
Jul, 2015
(9 years ago) |
Expired
|
| US5521184 | Pyrimidine derivatives and processes for the preparation thereof |
Jan, 2015
(9 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Gleevec's patents.
Latest Legal Activities on Gleevec's Patents
Given below is the list of recent legal activities going on the following patents of Gleevec.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Post Issue Communication - Certificate of Correction | 17 Jun, 2019 | US6958335 |
| Recordation of Patent Grant Mailed Critical | 09 Jun, 2009 | US7544799 |
| Patent Issue Date Used in PTA Calculation Critical | 09 Jun, 2009 | US7544799 |
| Issue Notification Mailed Critical | 20 May, 2009 | US7544799 |
| Dispatch to FDC | 04 May, 2009 | US7544799 |
| Application Is Considered Ready for Issue Critical | 04 May, 2009 | US7544799 |
| Printer Rush- No mailing | 01 May, 2009 | US7544799 |
| Issue Fee Payment Received Critical | 29 Apr, 2009 | US7544799 |
| Issue Fee Payment Verified Critical | 29 Apr, 2009 | US7544799 |
| Mail Notice of Allowance Critical | 30 Jan, 2009 | US7544799 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Gleevec and ongoing litigations to help you estimate the early arrival of Gleevec generic.
Gleevec's Litigations
Gleevec been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Mar 05, 2003, against patent number US6894051. The petitioner , challenged the validity of this patent, with JURG ZIMMERMANN et al as the respondent. Click below to track the latest information on how companies are challenging Gleevec's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US6894051 | March, 2003 |
Decision
(24 Nov, 2003) | JURG ZIMMERMANN et al | |
FDA has granted some exclusivities to Gleevec. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Gleevec, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Gleevec.
Exclusivity Information
Gleevec holds 4 exclusivities. All of its exclusivities have expired in 2020. Details of Gleevec's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-583) | Dec 19, 2011 |
| Orphan Drug Exclusivity(ODE) | Jan 25, 2020 |
| New Indication(I-666) | Jan 25, 2016 |
| Orphan Drug Exclusivity(ODE-40) | Jan 25, 2020 |
US patents provide insights into the exclusivity only within the United States, but Gleevec is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Gleevec's family patents as well as insights into ongoing legal events on those patents.
Gleevec's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Gleevec's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 19, 2022 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Gleevec Generic API suppliers:
Imatinib Mesylate is the generic name for the brand Gleevec. 14 different companies have already filed for the generic of Gleevec, with Amneal Pharms having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Gleevec's generic
How can I launch a generic of Gleevec before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Gleevec's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Gleevec's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Gleevec -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 100 mg and 400 mg | 12 Mar, 2007 | 1 | 03 Dec, 2015 | 23 Nov, 2019 | Non-forfeiture |
About Gleevec
Gleevec is a drug owned by Novartis Pharmaceuticals Corp. It is used for treating tumors and gastrointestinal stromal tumors (GIST) in patients with CD117 positive unresectable or metastatic disease. Gleevec uses Imatinib Mesylate as an active ingredient. Gleevec was launched by Novartis in 2003.
Approval Date:
Gleevec was approved by FDA for market use on 18 April, 2003.
Active Ingredient:
Gleevec uses Imatinib Mesylate as the active ingredient. Check out other Drugs and Companies using Imatinib Mesylate ingredient
Treatment:
Gleevec is used for treating tumors and gastrointestinal stromal tumors (GIST) in patients with CD117 positive unresectable or metastatic disease.
Dosage:
Gleevec is available in the following dosage forms - tablet form for oral use, capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 100MG BASE | TABLET | Prescription | ORAL |
| EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE | Discontinued | ORAL |
| EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE | Discontinued | ORAL |
| EQ 400MG BASE | TABLET | Prescription | ORAL |