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 | 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 | Novartis |
| Tasigna | US8501760 | Pharmaceutical compositions comprising nilotinib or its salt | Jul 18, 2026 | 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 | 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 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 10 Oct, 2019 | US8163904 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 07 Dec, 2018 | US9061029 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 19 Jul, 2018 | US7169791 |
Nilotinib Hydrochloride's Family Patents
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Nilotinib Hydrochloride Generic API Manufacturers
Several generic applications have been filed for Nilotinib Hydrochloride.
Given below is the list of companies who have filed for Nilotinib Hydrochloride generic, along with the locations of their manufacturing plants worldwide.
1. APOTEX
Apotex Inc has filed for 3 different strengths of generic version for Nilotinib Hydrochloride. Given below are the details of the strengths of this generic introduced by Apotex.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 50MG BASE | capsule | Discontinued | ORAL | N/A | Jan 5, 2024 |
| EQ 150MG BASE | capsule | Discontinued | ORAL | N/A | Jan 5, 2024 |
| EQ 200MG BASE | capsule | Discontinued | ORAL | N/A | Jan 5, 2024 |
Manufacturing Plant Locations New
Apotex's manufacturing plants are situated in 3 countries - United States, Canada, India. Given below are the details of these plant locations as well as the firm names of Apotex as present at those locations.
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United States |
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| Canada |
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| India |
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