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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-eight 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: | 78 |
| US Patents: | 3 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 16 |
| Clinical Trials: | 48 |
| 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 |
|---|---|
| Otsuka Beijing Research Institute | Phase 2 |
| Apices Soluciones S.L. | Phase 2 |
| Incyte Biosciences UK | 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 | 203469-003 | Apr 23, 2015 | RX | Yes | No | 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 | 203469-002 | 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 | 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) | 2007133562 | Start Trial |
| Denmark | 2495016 | Start Trial |
| European Patent Office | 1973545 | Start Trial |
| Australia | 2018201013 | Start Trial |
| Eurasian Patent Organization | 027573 | 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 | 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 | 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 | 92327 | Luxembourg | Start Trial | PRODUCT NAME: PONATINIB SOUS TOUTES SES FORMES TELLES QUE PROTEGEES PAR LE BREVET DE BASE |
| 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 | 490 | Finland | Start Trial | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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