DrugPatentWatch Database Preview
TASIGNA Drug Profile
Which patents cover Tasigna, and when can generic versions of Tasigna launch?
Tasigna is a drug marketed by Novartis and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.
This drug has two hundred and sixty-seven patent family members in fifty-one countries.
The generic ingredient in TASIGNA is nilotinib hydrochloride. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the nilotinib hydrochloride profile page.
Summary for TASIGNA
| International Patents: | 267 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 111 |
| Clinical Trials: | 57 |
| Patent Applications: | 4,153 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for TASIGNA |
| DailyMed Link: | TASIGNA at DailyMed |
Generic Entry Opportunity Date for TASIGNA
Generic Entry Date for TASIGNA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for TASIGNA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Institutes of Health (NIH) | Phase 2 |
| Institut Bergonié | Phase 3 |
| Institut National de la Santé Et de la Recherche Médicale, France | Phase 3 |
Pharmacology for TASIGNA
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Protein Kinase Inhibitors |
Synonyms for TASIGNA
| 139316-EP2270008A1 |
| 139316-EP2292617A1 |
| 3gp0 |
| 4-Methyl-3-((4-(3-pyridinyl)-2-pyrimidinyl)amino)-N-(5-(4-methyl-1H-imidazol-1-yl)-3-(trifluoromethyl)phenyl)benzamide |
| 4-Methyl-3-(4-(3-pyridinyl)-2-pyrimidinyl)amino)-N-[5-(4-methyl-1H-imidazol-1-yl)-3-(trifluoromethyl)phenyl]benzamide |
| 4-Methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-N-[5-(4-methyl-1H-imidazol-1-yl)-3-(trifluoromethyl)phenyl]benzamide |
| 4-Methyl-N-(3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)-phenyl)-3-((4-(pyridin-3-yl)pyrimidin-2-yl)amino)benzamide |
| 4-Methyl-N-(3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(pyridin-3-yl)pyrimidin-2 |
| 4-Methyl-N-(3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(pyridin-3-yl)pyrimidin-2-yl)amino)benzamide |
| 4-Methyl-N-(3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-(4-(pyridin-3-yl)pyrimidin-2-ylamino)benzamide |
| 4-methyl-N-(3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-{(4-(pyridin-3-yl)pyrimidin-2-yl)amino}benzamide |
| 4-Methyl-N-(3-(4-methylimidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-pyridin-3-ylpyrimidin-2-yl)amino)benzamide |
| 4-methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[(4-pyridin-3-ylpyrimidin-2-yl)amino]benzamide |
| 4-methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-benzamide |
| 4-Methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]benzamide |
| 4-methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-{[4-(pyridin-3-yl)pyrimidin-2-yl]amino}benzamide |
| 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide |
| 4-methyl-N-[3-(4-methylimidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[(4-pyridin-3-ylpyrimidin-2-yl)amino]benzamide |
| 4-methyl-N-[3-(4-methylimidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[[4-(3-pyridyl)pyrimidin-2-yl]amino]benzamide |
| 49312-EP2270008A1 |
| 49312-EP2292617A1 |
| 49312-EP2305667A2 |
| 49312-EP2311840A1 |
| 571N100 |
| 641571-10-0 |
| 78680-EP2305667A2 |
| AB0007991 |
| AB01273978_03 |
| AB01273978-01 |
| AB01273978-02 |
| ABP000478 |
| AC-647 |
| AC1LD8U3 |
| AKOS005063561 |
| AM20090651 |
| AMN 107 |
| AMN 107; Tasigna |
| AMN-107 |
| AMN107 |
| AN-5308 |
| ANW-41982 |
| AOB87115 |
| API0003575 |
| AS-16214 |
| AX8144766 |
| BC224537 |
| BCP01367 |
| BCP9000989 |
| BCPP000149 |
| BDBM50237710 |
| Benzamide, 4-methyl-N-((3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-(4-(3-pyridinyl)-2-pyrimidinyl)amino)- |
| Benzamide, 4-methyl-N-(3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-(4-(3-pyridinyl)-2-pyrimidinyl)amino)- |
| benzamide, 4-methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]- |
| Benzamide, 4-methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]- (9CI) |
| BR-59889 |
| BRD-K81528515-001-04-7 |
| C28H22F3N7O |
| cc-353 |
| CHEBI:52172 |
| CHEMBL255863 |
| CS-0102 |
| CTK8B3214 |
| D08953 |
| DB04868 |
| DTXSID5042663 |
| EC 700-544-5 |
| EN002707 |
| F41401512X |
| FC0027 |
| FT-0654026 |
| GP5854 |
| GTPL5697 |
| HHZIURLSWUIHRB-UHFFFAOYSA-N |
| HMS3244A13 |
| HMS3244A14 |
| HMS3244B13 |
| HMS3654M07 |
| HSDB 7842 |
| HY-10159 |
| I01-1225 |
| KS-00000GT9 |
| MFCD09833716 |
| MLS003915611 |
| MLS006010160 |
| MolPort-003-987-089 |
| N-(3-(3-(1H-Imidazolyl)propoxy)phenyl)-4-methyl-3-((4-(3-pyridinyl)-2-pyrimidinyl)amino)benzamide |
| N-8207 |
| NCGC00183285-01 |
| NCGC00183285-03 |
| NCGC00183285-04 |
| NCGC00183285-09 |
| Nilotinib |
| Nilotinib (AMN-107) |
| Nilotinib (USAN/INN) |
| Nilotinib [USAN:INN:BAN] |
| Nilotinib & its intermediates |
| Nilotinib, AMN107, Tasigna |
| Nilotinib,AMN107,Tasigna;4-methyl-N-(3-(4-methylimidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-pyridin-3-ylpyrimidin-2-yl)amino)benzamide |
| Nilotinib; |
| Nilotinib(AMN-107) |
| Nilotinib/ |
| nilotinibum |
| NSC-747599 |
| NSC747599 |
| P111010 |
| PubChem18272 |
| Q-101348 |
| QCR-112 |
| RS0102 |
| RTX-011143 |
| S-6060 |
| s1033 |
| SB17315 |
| SC-19640 |
| SCHEMBL7901 |
| SMR002544680 |
| SR-01000931150 |
| SR-01000931150-2 |
| ST2413627 |
| SW218083-2 |
| SYN1057 |
| Tasigna (Novartis) |
| TL8004531 |
| UNII-F41401512X |
| V0705 |
| ZINC6716957 |
US Patents and Regulatory Information for TASIGNA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis | TASIGNA | nilotinib hydrochloride | CAPSULE;ORAL | 022068-001 | Oct 29, 2007 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Novartis | TASIGNA | nilotinib hydrochloride | CAPSULE;ORAL | 022068-001 | Oct 29, 2007 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Novartis | TASIGNA | nilotinib hydrochloride | CAPSULE;ORAL | 022068-001 | Oct 29, 2007 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Novartis | TASIGNA | nilotinib hydrochloride | CAPSULE;ORAL | 022068-001 | Oct 29, 2007 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Novartis | TASIGNA | nilotinib hydrochloride | CAPSULE;ORAL | 022068-003 | Mar 22, 2018 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Paragraph IV (Patent) Challenges for TASIGNA
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Capsules | 150 mg and 200 mg | ➤ Subscribe | Start Trial |
International Patents for TASIGNA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Nicaragua | 200800017 | Start Trial |
| Russian Federation | 2605551 | Start Trial |
| China | 1675195 | Start Trial |
| South Korea | 20150100946 | Start Trial |
| Brazil | 112012011693 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
