Imatinib Mesylate Patent Expiration
Imatinib Mesylate is Used for treating tumors and gastrointestinal stromal tumors (GIST) in patients with CD117 positive unresectable or metastatic disease. It was first introduced by Novartis Pharmaceuticals Corp
Imatinib Mesylate Patents
Given below is the list of patents protecting Imatinib Mesylate, along with the drug name that holds that patent and the company name owning that drug.
| Drug Used in | Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Drug Owner |
|---|---|---|---|---|
| Imkeldi | US11957681 | Liquid dosage forms of Imatinib | Apr 27, 2040 | Shorla Oncology |
| Gleevec |
US6958335 (Pediatric) | Treatment of gastrointestinal stromal tumors |
Jun 19, 2022
(Expired) | Novartis |
| Gleevec | US6958335 | Treatment of gastrointestinal stromal tumors |
Dec 19, 2021
(Expired) | Novartis |
| Gleevec |
US6894051 (Pediatric) | Crystal modification of a N-phenyl-2-pyrimidineamine derivative, processes for its manufacture and its use |
Nov 23, 2019
(Expired) | Novartis |
| Gleevec |
US7544799 (Pediatric) | Crystal modification of a N-phenyl-2-pyrimidineamine derivative, processes for its manufacture and its use |
Jul 16, 2019
(Expired) | Novartis |
| Gleevec |
USRE43932 (Pediatric) | Crystal modification of a N-phenyl-2-pyrimidineamine derivative, processes for its manufacture and its use |
Jul 16, 2019
(Expired) | Novartis |
| Gleevec | US6894051 | Crystal modification of a N-phenyl-2-pyrimidineamine derivative, processes for its manufacture and its use |
May 23, 2019
(Expired) | Novartis |
| Gleevec | US7544799 | Crystal modification of a N-phenyl-2-pyrimidineamine derivative, processes for its manufacture and its use |
Jan 16, 2019
(Expired) | Novartis |
| Gleevec | USRE43932 | Crystal modification of a N-phenyl-2-pyrimidineamine derivative, processes for its manufacture and its use |
Jan 16, 2019
(Expired) | Novartis |
| Gleevec |
USRE43932 (Pediatric) | Crystal modification of a N-phenyl-2-pyrimidineamine derivative, processes for its manufacture and its use |
Jan 16, 2019
(Expired) | Novartis |
| Gleevec | USRE43932 | Crystal modification of a N-phenyl-2-pyrimidineamine derivative, processes for its manufacture and its use |
Jul 16, 2018
(Expired) | Novartis |
| Gleevec |
US5521184 (Pediatric) | Pyrimidine derivatives and processes for the preparation thereof |
Jul 04, 2015
(Expired) | Novartis |
| Gleevec | US5521184 | Pyrimidine derivatives and processes for the preparation thereof |
Jan 04, 2015
(Expired) | Novartis |
Imatinib Mesylate's Family Patents
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Clinical Trials
Recent Clinical Trials on Imatinib Mesylate:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
| Title | Lead Sponsor | Collaborators | Status | Phases |
|---|---|---|---|---|
 | ||||
| Sorafenib in Treating Patients With Malignant Gastrointestinal Stromal Tumor That Progressed During or After Previous Treatment With Imatinib Mesylate and Sunitinib Malate | National Cancer Institute (NCI) | NA |
ACTIVE NOT RECRUITING
(Aug 1, 2026)
| PHASE2 |
| Pioglityazone and Imatinib for CML Patients | Versailles Hospital | NA |
COMPLETED
(Jul 1, 2026)
| PHASE2 |
| A Prospective Randomized Phase II Study Evaluating the Monitoring of Imatinib Mesylate Plasmatic Through Level in Patients Newly Diagnosed With CP-CML | Versailles Hospital | NA |
COMPLETED
(Jul 1, 2026)
| PHASE2 |