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PONATINIB HYDROCHLORIDE - Generic Drug Details
What are the generic drug sources for ponatinib hydrochloride and what is the scope of patent protection?
Ponatinib hydrochloride
is the generic ingredient in one branded drug marketed by Ariad and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Ponatinib hydrochloride has seventy-six patent family members in twenty-one countries.
There is one drug master file entry for ponatinib hydrochloride. Two suppliers are listed for this compound.
Summary for PONATINIB HYDROCHLORIDE
International Patents: | 76 |
US Patents: | 3 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 1 |
Suppliers / Packagers: | 2 |
Bulk Api Vendors: | 15 |
Clinical Trials: | 45 |
Patent Applications: | 11 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for PONATINIB HYDROCHLORIDE |
DailyMed Link: | PONATINIB HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for PONATINIB HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Centre Leon Berard | Phase 2 |
Incyte Biosciences International Sàrl | Phase 1/Phase 2 |
Fundación Teófilo Hernando, Spain | Phase 2 |
Recent Litigation for PONATINIB HYDROCHLORIDE
Identify potential future generic entrants
District Court Litigation
Case Name | Date |
---|---|
Ariad Pharmaceuticals, Inc. v. Matal |
Pharmacology for PONATINIB HYDROCHLORIDE
Drug Class | Kinase Inhibitor |
Mechanism of Action | Protein Kinase Inhibitors |
Synonyms for PONATINIB HYDROCHLORIDE
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 monohydrochloride |
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-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-(4-((4-methylpiperazin-1-yl)methyl)-3-(trifluoromethyl)phenyl)benzamide hydrochloride |
96R6PU3D8J |
AKOS030621539 |
AOB3899 |
AP 24534 hydrochloride |
AP-24534 HCl |
AP24534 HCL |
AP24534 Hydrochloride |
AS-16772 |
BCP10906 |
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) |
BWTNNZPNKQIADY-UHFFFAOYSA-N |
C29H28ClF3N6O |
CHEMBL2105708 |
D09951 |
DTXSID50149655 |
Iclusig |
Iclusig (TN) |
Ponatinib (HCl salt) |
Ponatinib HCl |
Ponatinib hydrochloride (JAN/USAN) |
Ponatinib hydrochloride [USAN] |
Ponatinib Mono-hydrochloride |
SCHEMBL15798559 |
UNII-96R6PU3D8J |
Y1466 |
US Patents and Regulatory Information for PONATINIB HYDROCHLORIDE
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 | 203469-002 | Dec 14, 2012 | RX | Yes | Yes | Start Trial | Start Trial | 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 | 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 | 203469-003 | 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 | Y | 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 |
International Patents for PONATINIB HYDROCHLORIDE
Country | Patent Number | Estimated Expiration |
---|---|---|
World Intellectual Property Organization (WIPO) | 2007075869 | Start Trial |
Israel | 229351 | Start Trial |
Israel | 239445 | Start Trial |
Japan | 6447508 | Start Trial |
Israel | 229350 | Start Trial |
Canada | 2815506 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for PONATINIB HYDROCHLORIDE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
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 | C01973545/01 | Switzerland | Start Trial | PRODUCT NAME: PONATINIBUM; REGISTRATION NO/DATE: SWISSMEDIC 63097 12.02.2014 |
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 | 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 | C300631 | Netherlands | Start Trial | PRODUCT NAME: PONATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, SOLVAAT OF HYDRAAT; REGISTRATION NO/DATE: EU/1/13/839/001-004 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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