Ponatinib hydrochloride - Generic Drug Details
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What are the generic sources for ponatinib hydrochloride and what is the scope of freedom to operate?
Ponatinib hydrochloride
is the generic ingredient in two branded drugs marketed by Takeda Pharms Usa and Apotex, and is included in two NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.Ponatinib hydrochloride has one hundred and four patent family members in twenty-three countries.
There is one drug master file entry for ponatinib hydrochloride. One supplier is listed for this compound.
Summary for ponatinib hydrochloride
International Patents: | 104 |
US Patents: | 6 |
Tradenames: | 2 |
Applicants: | 2 |
NDAs: | 2 |
Drug Master File Entries: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 37 |
Clinical Trials: | 61 |
Patent Applications: | 658 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ponatinib hydrochloride |
What excipients (inactive ingredients) are in ponatinib hydrochloride? | ponatinib hydrochloride excipients list |
DailyMed Link: | ponatinib hydrochloride at DailyMed |
Recent Clinical Trials for ponatinib hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Institute of Hematology & Blood Diseases Hospital | Phase 2 |
University of Michigan Rogel Cancer Center | Phase 2 |
University of Chicago | Phase 2 |
Pharmacology for ponatinib hydrochloride
Drug Class | Kinase Inhibitor |
Mechanism of Action | Protein Kinase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for ponatinib hydrochloride
Paragraph IV (Patent) Challenges for PONATINIB HYDROCHLORIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ICLUSIG | Tablets | ponatinib hydrochloride | 10 mg and 30 mg | 203469 | 1 | 2022-12-12 |
ICLUSIG | Tablets | ponatinib hydrochloride | 15 mg and 45 mg | 203469 | 1 | 2021-03-31 |
US Patents and Regulatory Information for ponatinib hydrochloride
International Patents for ponatinib hydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Cyprus | 1113907 | ⤷ Try a Trial | |
Japan | 2009536650 | ⤷ Try a Trial | |
Australia | 2006331673 | Bicyclic heteroaryl compounds | ⤷ Try a Trial |
Mexico | 2021002259 | FORMAS CRISTALINAS DE 3-(IMIDAZO[1,2-B] PIRIDAZIN-3- ILETINIL)-4-METIL-N-(4-[(4-METILPIPERAZIN-1-IL) METIL]-3-(TRIFLUOROMETIL)FENIL) BENZAMIDA Y SU SAL DE MONOCLORHIDRATO. (CRYSTALLINE FORMS OF 3-(IMIDAZO[1,2-B] PYRIDAZIN-3-YLETHYNYL)-4-M ETHYL-N-(4-[(4-METHYLPIPERAZIN-1-YL) METHYL]-3-(TRIFLUOROMETHYL)P HENYL)BENZAMIDE AND ITS MONO HYDROCHLORIDE SALT.) | ⤷ Try a Trial |
Australia | 2016210725 | Crystalline forms of 3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-{4-[(4-methylpiperazin-1-yl)methyl]-3-(trifluoromethyl)phenyl}benzamide mono hydrochloride | ⤷ Try a Trial |
European Patent Office | 2024366 | COMPOSÉS D'HÉTÉROARYLE MONOCYCLIQUE (MONOCYCLIC HETEROARYL COMPOUNDS) | ⤷ Try a Trial |
Eurasian Patent Organization | 027573 | БИЦИКЛИЧЕСКИЕ ГЕТЕРОАРИЛЬНЫЕ СОЕДИНЕНИЯ (BICYCLIC HETEROARYL COMPOUNDS) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ponatinib hydrochloride
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1973545 | CR 2013 00066 | Denmark | ⤷ Try a 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 | PA2013027 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: PONATINIBUM; REGISTRATION NO/DATE: EU/1/13/839/001, 2013 07 01 EU/1/13/839/002, 2013 07 01 EU/1/13/839/003, 2013 07 01 EU/1/13/839/004 20130701 |
1973545 | SPC/GB13/077 | United Kingdom | ⤷ Try a 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 | C300631 | Netherlands | ⤷ Try a 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 | 2013C/073 | Belgium | ⤷ Try a Trial | PRODUCT NAME: PONATINIB; AUTHORISATION NUMBER AND DATE: EU/1/13/839/001 20130703 |
1973545 | 122013000152 | Germany | ⤷ Try a 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 | 151 5025-2013 | Slovakia | ⤷ Try a 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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