Nilotinib Hydrochloride Patent Expiration
Nilotinib Hydrochloride is Used for treating Philadelphia chromosome-positive chronic myeloid leukemia (PH+CML) with nilotinib dispersed in a fruit preparation. It was first introduced by Novartis Pharmaceuticals Corp
Nilotinib Hydrochloride Patents
Given below is the list of patents protecting Nilotinib Hydrochloride, 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 |
|---|---|---|---|---|
| Tasigna |
US9061029 (Pediatric) | Method of treating proliferative disorders and other pathological conditions mediated by Bcr-Abl, c-Kit, DDR1, DDR2 or PDGF-R kinase activity | Oct 07, 2032 | Novartis |
| Tasigna | US9061029 | Method of treating proliferative disorders and other pathological conditions mediated by Bcr-Abl, c-Kit, DDR1, DDR2 or PDGF-R kinase activity | Apr 07, 2032 | Novartis |
| Tasigna |
US8163904 (Pediatric) | Salts of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-Benzamide | Feb 23, 2029 | Novartis |
| Tasigna | US8163904 | Salts of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-Benzamide | Aug 23, 2028 | Novartis |
| Tasigna |
US8293756 (Pediatric) | Pharmaceutical compositions comprising nilotinib hydrochloride monohydrate | Mar 25, 2028 | Novartis |
| Tasigna | US8293756 | Pharmaceutical compositions comprising nilotinib hydrochloride monohydrate | Sep 25, 2027 | Novartis |
| Tasigna |
US8389537 (Pediatric) | Salts of 4-methyl N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide | Jan 18, 2027 | Novartis |
| Tasigna |
US8415363 (Pediatric) | Crystalline forms of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide | Jan 18, 2027 | Novartis |
| Tasigna |
US8501760 (Pediatric) | Pharmaceutical compositions comprising nilotinib or its salt | Jan 18, 2027 | Novartis |
| Tasigna | US8389537 | Salts of 4-methyl N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide |
Jul 18, 2026
(Expired) | Novartis |
| Tasigna | US8415363 | Crystalline forms of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide |
Jul 18, 2026
(Expired) | Novartis |
| Tasigna | US8501760 | Pharmaceutical compositions comprising nilotinib or its salt |
Jul 18, 2026
(Expired) | Novartis |
| Tasigna |
US7169791 (Pediatric) | Inhibitors of tyrosine kinases |
Jan 04, 2024
(Expired) | Novartis |
| Tasigna | US7169791 | Inhibitors of tyrosine kinases |
Jul 04, 2023
(Expired) | Novartis |
| Tasigna | US7169791 | Inhibitors of tyrosine kinases |
Jul 04, 2023
(Expired) | Novartis |
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 Nilotinib Hydrochloride's patents.
Latest Legal Activities on Nilotinib Hydrochloride's Patents
Given below is the list recent legal activities going on the following patents of Nilotinib Hydrochloride.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 06 Jan, 2025 | US8501760 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 25 Sep, 2024 | US8415363 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 21 Aug, 2024 | US8389537 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 10 Apr, 2024 | US8293756 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 11 Oct, 2023 | US8163904 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 07 Dec, 2022 | US9061029 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Jan, 2021 | US8501760 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 24 Sep, 2020 | US8415363 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 21 Aug, 2020 | US8389537 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 14 Apr, 2020 | US8293756 |
Nilotinib Hydrochloride's Family Patents
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Clinical Trials
Recent Clinical Trials on Nilotinib Hydrochloride:
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 |
|---|---|---|---|---|
 | ||||
| Testing the Use of Nilotinib and Paclitaxel as a Treatment for Patients With Prior Taxane Treatment, A ComboMATCH Treatment Trial | National Cancer Institute (NCI) | NA |
ACTIVE NOT RECRUITING
(May 1, 2026)
| PHASE2 |