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 in its drug Tasigna on Oct 29, 2007. 2 different companies have introduced drugs containing Nilotinib Hydrochloride.


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 US7169791 Inhibitors of tyrosine kinases Jul 04, 2023

(Expired)

Novartis
Tasigna US7169791 Inhibitors of tyrosine kinases Jul 04, 2023

(Expired)

Novartis
Tasigna US7169791

(Pediatric)

Inhibitors of tyrosine kinases Jan 04, 2024

(Expired)

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 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 US8293756 Pharmaceutical compositions comprising nilotinib hydrochloride monohydrate Sep 25, 2027 Novartis
Tasigna US8293756

(Pediatric)

Pharmaceutical compositions comprising nilotinib hydrochloride monohydrate Mar 25, 2028 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 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 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 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 Pharmaceutical compositions comprising nilotinib or its salt Jul 18, 2026 Novartis
Tasigna US8501760

(Pediatric)

Pharmaceutical compositions comprising nilotinib or its salt Jan 18, 2027 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 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


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.

Given below is the list recent legal activities going on the following patents of Nilotinib Hydrochloride.

Event Date Patent/Publication
Patent litigations
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



Coming Soon

Patent Strength Analyzer

Will this be useful for you?

YesNo

Thank you for your response 🥳

Nilotinib Hydrochloride Generics

Several generic applications have been filed for Nilotinib Hydrochloride.

Given below is the list of companies who have filed for Nilotinib Hydrochloride generic.


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