Tasigna is a drug owned by Novartis Pharmaceuticals Corp. It is protected by 14 US drug patents filed from 2013 to 2018. Out of these, 12 drug patents are active and 2 have expired. Tasigna's patents will be open to challenges from 23 March, 2028. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 07, 2032. Details of Tasigna'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. | |||
| US9061029 | Method of treating proliferative disorders and other pathological conditions mediated by Bcr-Abl, c-Kit, DDR1, DDR2 or PDGF-R kinase activity |
Apr, 2032
(7 years from now) | Active |
| 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, 2028
(3 years from now) | Active |
| 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, 2026
(1 year, 7 months from now) | Active |
| US7169791 | Inhibitors of tyrosine kinases |
Jul, 2023
(1 year, 4 months ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
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, 2032
(7 years from now) | Active |
|
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, 2029
(4 years from now) | Active |
|
US8293756 (Pediatric) | Pharmaceutical compositions comprising nilotinib hydrochloride monohydrate |
Mar, 2028
(3 years from now) | Active |
| US8293756 | Pharmaceutical compositions comprising nilotinib hydrochloride monohydrate |
Sep, 2027
(2 years from now) | Active |
|
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, 2027
(2 years from now) | Active |
|
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, 2027
(2 years from now) | Active |
|
US8501760 (Pediatric) | Pharmaceutical compositions comprising nilotinib or its salt |
Jan, 2027
(2 years from now) | Active |
| US8501760 | Pharmaceutical compositions comprising nilotinib or its salt |
Jul, 2026
(1 year, 7 months from now) | Active |
| 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, 2026
(1 year, 7 months from now) | Active |
|
US7169791 (Pediatric) | Inhibitors of tyrosine kinases |
Jan, 2024
(10 months ago) |
Expired
|
| US7169791 | Inhibitors of tyrosine kinases |
Jul, 2023
(1 year, 4 months 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 Tasigna's patents.
Latest Legal Activities on Tasigna's Patents
Given below is the list of recent legal activities going on the following patents of Tasigna.
| 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 |
FDA has granted several exclusivities to Tasigna. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Tasigna, 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 Tasigna.
Exclusivity Information
Tasigna holds 9 exclusivities out of which 5 have expired. Its last outstanding exclusivity is set to expire in 2029. Details of Tasigna's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Oct 29, 2012 |
| New Indication(I-627) | Jun 17, 2014 |
| Orphan Drug Exclusivity(ODE) | Oct 29, 2014 |
| New Dosing Schedule(D-170) | Dec 22, 2020 |
| New Patient Population(NPP) | Mar 22, 2021 |
| Orphan Drug Exclusivity(ODE-171) | Mar 22, 2025 |
| Orphan Drug Exclusivity(ODE-172) | Mar 22, 2025 |
| Orphan Drug Exclusivity(ODE-380) | Sep 23, 2028 |
| Pediatric Exclusivity(PED) | Mar 23, 2029 |
Several oppositions have been filed on Tasigna's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Tasigna's generic, the next section provides detailed information on ongoing and past EP oppositions related to Tasigna patents.
Tasigna's Oppositions Filed in EPO
Tasigna has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Mar 08, 2013, by D Young & Co. This opposition was filed on patent number EP06800109A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP10173956A | Nov, 2017 | D Young & Co LLP | Patent maintained as amended |
| EP10781781A | Nov, 2016 | Generics (U.K.) Limited | Granted and Under Opposition |
| EP10781781A | Nov, 2016 | Hamm&Wittkopp Patentanwälte PartmbB | Granted and Under Opposition |
| EP10781781A | Nov, 2016 | Teva Pharmaceutical Industries Ltd | Granted and Under Opposition |
| EP10781781A | Nov, 2016 | Intas Pharmaceuticals Ltd. | Granted and Under Opposition |
| EP10781781A | Nov, 2016 | Fresenius Kabi Deutschland GmbH | Granted and Under Opposition |
| EP07820560A | Jun, 2016 | medac Gesellschaft für klinische Spezialpräparate mbH | Patent maintained as amended |
| EP07820560A | Jun, 2016 | Fresenius Kabi Deutschland GmbH | Patent maintained as amended |
| EP07820560A | Jun, 2016 | Strawman Limited | Patent maintained as amended |
| EP07820560A | Jun, 2016 | Generics [UK] Limited | Patent maintained as amended |
| EP06800109A | Mar, 2013 | Actavis Group Ptc Ehf | Revoked |
| EP06800109A | Mar, 2013 | D YOUNG & CO | Revoked |
US patents provide insights into the exclusivity only within the United States, but Tasigna 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 Tasigna's family patents as well as insights into ongoing legal events on those patents.
Tasigna's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Tasigna's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 07, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Tasigna Generic API suppliers:
Nilotinib Hydrochloride is the generic name for the brand Tasigna. 1 company has already filed for the generic of Tasigna. Check out the entire list of companies who have already received approval for Tasigna's generic
How can I launch a generic of Tasigna before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Tasigna's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Tasigna'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 Tasigna -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 50 mg | 17 Oct, 2019 | 1 | 07 Apr, 2032 | ||
| 150 mg and 200 mg | 08 Nov, 2013 | 1 | 18 Jul, 2026 |
Alternative Brands for Tasigna
Tasigna which is used for treating Philadelphia chromosome-positive chronic myeloid leukemia (PH+CML) with nilotinib dispersed in a fruit preparation., has several other brand drugs in the same treatment category . Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Novartis |
| |||
About Tasigna
Tasigna is a drug owned by Novartis Pharmaceuticals Corp. It is used for treating Philadelphia chromosome-positive chronic myeloid leukemia (PH+CML) with nilotinib dispersed in a fruit preparation. Tasigna uses Nilotinib Hydrochloride as an active ingredient. Tasigna was launched by Novartis in 2018.
Approval Date:
Tasigna was approved by FDA for market use on 22 March, 2018.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Tasigna is 22 March, 2018, its NCE-1 date is estimated to be 23 March, 2028.
Active Ingredient:
Tasigna uses Nilotinib Hydrochloride as the active ingredient. Check out other Drugs and Companies using Nilotinib Hydrochloride ingredient
Treatment:
Tasigna is used for treating Philadelphia chromosome-positive chronic myeloid leukemia (PH+CML) with nilotinib dispersed in a fruit preparation.
Dosage:
Tasigna is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 50MG BASE | CAPSULE | Prescription | ORAL |
| EQ 150MG BASE | CAPSULE | Prescription | ORAL |
| EQ 200MG BASE | CAPSULE | Prescription | ORAL |