DrugPatentWatch Database Preview
ICLUSIG Drug Profile
When do Iclusig patents expire, and what generic alternatives are available?
Iclusig is a drug marketed by Ariad and is included in one NDA. There are three patents protecting this drug.
This drug has seventy-four patent family members in twenty countries.
The generic ingredient in ICLUSIG is ponatinib hydrochloride. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the ponatinib hydrochloride profile page.
Summary for ICLUSIG
| International Patents: | 74 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 90 |
| Clinical Trials: | 18 |
| Patent Applications: | 76 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ICLUSIG |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ICLUSIG |
| DailyMed Link: | ICLUSIG at DailyMed |
Generic Entry Opportunity Date for ICLUSIG
Generic Entry Date for ICLUSIG*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;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 ICLUSIG
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Antonio Fojo | Phase 2 |
| Millennium Pharmaceuticals, Inc. | Phase 2 |
| Versailles Hospital | Phase 2 |
Recent Litigation for ICLUSIG
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Ariad Pharmaceuticals, Inc. v. Matal |
Pharmacology for ICLUSIG
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Protein Kinase Inhibitors |
Synonyms for ICLUSIG
| 0LI |
| 1114544-31-8 |
| 3-(2-(Imidazo(1,2-b)pyridazin-3-yl)ethynyl)-4-methyl-N-(4-((4-methylpiperazin-1- yl)methyl)-3-(trifluoromethyl)phenyl)benzamide |
| 3-(2-(Imidazo(1,2-b)pyridazin-3-yl)ethynyl)-4-methyl-N-(4-((4-methylpiperazin-1- yl)methyl)-3-(trifluoromethyl)phenyl)benzamide monohydrochloride |
| 3-(2-(Imidazo[1,2-b]pyridazin-3-yl)ethynyl)-4-methyl-N-(4-((4-methylpiperazin-1-yl)methyl)-3-(trifluoromethyl)phenyl)benzamide |
| 3-(2-{imidazo[1,2-b]pyridazin-3-yl}ethynyl)-4-methyl-N-{4-[(4-methylpiperazin-1-yl)methyl]-3-(trifluoromethyl)phenyl}benzamide hydrochloride |
| 3-(2-Imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-[4-[(4-methyl-1-piperazinyl)methyl]-3-(trifluoromethyl)phenyl]-benzamide |
| 3-(2-Imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-[4-[(4-methyl-1-piperazinyl)methyl]-3-(trifluoromethyl)phenyl]benzamide |
| 3-(2-imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-[4-[(4-methylpiperazin-1-yl)methyl]-3-(trifluoromethyl)phenyl]benzamide |
| 3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-(4-((4-methylpiperazin-1-yl)methyl)-3-(trifluoromethyl)phenyl)benzamide |
| 3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-(4-((4-methylpiperazin-1-yl)methyl)-3-(trifluoromethyl)phenyl)benzamide hydrochloride |
| 3-(Imidazo[1,2-B]pyridazin-3-Ylethynyl)-4-Methyl-N-{4-[(4-Methylpiperazin-1-Yl)methyl]-3-(Trifluoromethyl)phenyl}benzamide |
| 3-[2-(imidazo[1,2-b]pyridazin-3-yl)ethynyl]-4-methyl-n-{4-[(4-methylpiperazin-1-yl)methyl]-3-(trifluoromethyl)phenyl}benzamide |
| 4340891KFS |
| 943319-70-8 |
| 96R6PU3D8J |
| AB0008178 |
| AB01565847_03 |
| ABP000881 |
| AC-26973 |
| AKOS015995214 |
| AKOS030621539 |
| AM81261 |
| AOB3899 |
| AOB87302 |
| AP 24534 |
| AP 24534 hydrochloride |
| AP-24534 |
| AP-24534 HCl |
| AP-24534, Ponatinib, AP24534 |
| AP24534 |
| AP24534 - Ponatinib |
| AP24534 HCL |
| AP24534 Hydrochloride |
| AP24534,Ponatinib |
| AP24534(Ponatinib) |
| AS-16772 |
| AS-19133 |
| BC659935 |
| BCP02037 |
| BCP10906 |
| BCP9000307 |
| BCPP000397 |
| BDBM50322535 |
| Benzamide, 3-(2-imidazo(1,2-b)pyridazin-3-ylethynyl)-4-methyl-N-(4-((4-methyl-1- piperazinyl)methyl)-3-(trifluoromethyl)phenyl)- |
| Benzamide, 3-(2-imidazo(1,2-b)pyridazin-3-ylethynyl)-4-methyl-N-(4-((4-methyl-1- piperazinyl)methyl)-3-(trifluoromethyl)phenyl)-, hydrochloride (1:1) |
| BENZAMIDE, 3-(2-IMIDAZO[1,2-B]PYRIDAZIN-3-YLETHYNYL)-4-METHYL-N-[4-[(4-METHYL-1-PIPERAZINYL)METHYL]-3-(TRIFLUOROMETHYL)PHENYL]- |
| BRD-K44227013-001-02-3 |
| BWTNNZPNKQIADY-UHFFFAOYSA-N |
| C29H27F3N6O |
| C29H28ClF3N6O |
| CHEBI:78543 |
| CHEMBL1171837 |
| CHEMBL2105708 |
| CS-0204 |
| CTK5H6398 |
| D09950 |
| D09951 |
| DB08901 |
| DTXSID50149655 |
| DTXSID50241426 |
| EX-A067 |
| FT-0660376 |
| GTPL5890 |
| HMS3654H16 |
| HSDB 8184 |
| HY-12047 |
| Iclusig (TN) |
| KB-80068 |
| KS-00000772 |
| MLS006010166 |
| MolPort-009-679-483 |
| NCGC00263152-01 |
| NCGC00263152-02 |
| NCGC00263152-14 |
| PB34916 |
| PHXJVRSECIGDHY-UHFFFAOYSA-N |
| Ponatinb |
| PONATINIB |
| Ponatinib (AP24534) |
| Ponatinib (HCl salt) |
| Ponatinib (USAN/INN) |
| Ponatinib [USAN:INN] |
| Ponatinib HCl |
| Ponatinib hydrochloride |
| Ponatinib hydrochloride (JAN/USAN) |
| Ponatinib hydrochloride [USAN] |
| Ponatinib Mono-hydrochloride |
| ponatinibum |
| Q-4579 |
| QCR-6 |
| RL05926 |
| RT-011294 |
| S1490 |
| SC-53014 |
| SCHEMBL15798559 |
| SCHEMBL589260 |
| SMR004701274 |
| SW218091-2 |
| SYN1116 |
| UNII-4340891KFS |
| UNII-96R6PU3D8J |
| X4747 |
| Y1466 |
| ZINC36701290 |
US Patents and Regulatory Information for ICLUSIG
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ariad | ICLUSIG | ponatinib hydrochloride | TABLET;ORAL | 203469-001 | Dec 14, 2012 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Ariad | ICLUSIG | ponatinib hydrochloride | TABLET;ORAL | 203469-003 | Apr 23, 2015 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Ariad | ICLUSIG | ponatinib hydrochloride | TABLET;ORAL | 203469-001 | Dec 14, 2012 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Ariad | ICLUSIG | ponatinib hydrochloride | TABLET;ORAL | 203469-002 | Dec 14, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for ICLUSIG
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2007133562 | Start Trial |
| Chile | 2015001643 | Start Trial |
| Eurasian Patent Organization | 200870515 | Start Trial |
| Mexico | 2008014290 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ICLUSIG
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1973545 | 2013/059 | Ireland | Start Trial | PRODUCT NAME: PONATINIB IN ALL FORMS PROTECTED BY THE BASIC PATENT; REGISTRATION NO/DATE: EU/1/13/839/001-004 20130701 |
| 1973545 | PA2013027,C1973545 | Lithuania | Start Trial | PRODUCT NAME: PONATINIBUM; REGISTRATION NO/DATE: EU/1/13/839/001, 2013 07 03 EU/1/13/839/002, 2013 07 03 EU/1/13/839/003, 2013 07 03 EU/1/13/839/004 20130703 |
| 1973545 | CR 2013 00066 | Denmark | Start Trial | PRODUCT NAME: PONATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF INCLUDING THE HYDROCHLORIDE SALT THEREOF; REG. NO/DATE: EU/1/13/839/001-004 20130701 |
| 1973545 | C01973545/01 | Switzerland | Start Trial | PRODUCT NAME: PONATINIBUM; REGISTRATION NO/DATE: SWISSMEDIC 63097 12.02.2014 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
