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ICLUSIG Drug Profile
» See Plans and Pricing
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 eighty-six patent family members in twenty-three countries.
The generic ingredient in ICLUSIG is ponatinib hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the ponatinib hydrochloride profile page.
US ANDA Litigation and Generic Entry Outlook for Iclusig
Iclusig was eligible for patent challenges on December 14, 2016.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be December 12, 2033. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for ICLUSIG
| International Patents: | 86 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 98 |
| Clinical Trials: | 19 |
| Patent Applications: | 88 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information 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 |
|---|---|
| Otsuka Beijing Research Institute | Phase 2 |
| Antonio Fojo | Phase 2 |
| Millennium Pharmaceuticals, Inc. | Phase 2 |
Pharmacology for ICLUSIG
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Protein Kinase Inhibitors |
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 | Y | Y | Start Trial | ||
| Ariad | ICLUSIG | ponatinib hydrochloride | TABLET;ORAL | 203469-002 | Dec 14, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | 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 | Y | Y | Start Trial | ||
| Ariad | ICLUSIG | ponatinib hydrochloride | TABLET;ORAL | 203469-003 | Apr 23, 2015 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| 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 | 203469-002 | 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 |
|---|---|---|
| Japan | 2009536652 | Start Trial |
| Brazil | PI0621098 | Start Trial |
| Denmark | 2495016 | Start Trial |
| Canada | 3022250 | Start Trial |
| Mexico | 359147 | Start Trial |
| European Patent Office | 2023933 | 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 | 122013000152 | Germany | Start Trial | PRODUCT NAME: PONATINIB "BENZAMID, 3-(2-IMIDAZO(1,2-B)PYRIDAZIN-3-YLETHYNYL)-4-METHYL-N-(4-((4-METHYL-1-PIPERAZINYL)METHYL)-3-(TRIFLUORMETHYL)PHENYL)"; REGISTRATION 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 |
| 1973545 | SPC/GB13/077 | United Kingdom | Start Trial | PRODUCT NAME: PONATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT, SOLVATE OR HYDRATE THEREOF; REGISTERED: UK EU/1/13/839/001 20130703; UK EU/1/13/839/002 20130703; UK EU/1/13/839/003 20130703; UK EU/1/13/839/004 20130703 |
| 1973545 | 72/2013 | Austria | Start Trial | PRODUCT NAME: PONATINIB; REGISTRATION NO/DATE: EU/1/13/839 20130701 |
| 1973545 | 13C0069 | France | Start Trial | PRODUCT NAME: PONATINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, SOLVATE OU HYDRATE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/13/839/001-004 20130701 |
| 1973545 | 151 5025-2013 | Slovakia | Start Trial | (93) EU/1/13/839/001, EU/1/13/839/002, EU/1/13/839/003, EU/1/13/839/004, 1.7.2013, EU (94) 3.7.2028 |
| 1973545 | 1390059-2 | Sweden | Start Trial | PERIOD OF VALIDITY (FROM - UNTIL): 20261223 - 20280702 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
