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: | 62 |
Patent Applications: | 517 |
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 |
---|---|
Deutsche Leukämie- & Lymphom-Hilfe | Phase 2 |
Goethe University | Phase 2 |
German Federal Ministry of Education and Research | 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 |
---|---|---|---|
Japan | 2009521462 | ⤷ Sign Up | |
Canada | 2651822 | COMPOSES D'HETEROARYLE ACETYLENIQUE (ACETYLENIC HETEROARYL COMPOUNDS) | ⤷ Sign Up |
South Korea | 101436303 | ⤷ Sign Up | |
Mexico | 2021002258 | 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.) | ⤷ Sign Up |
Japan | 2022037122 | 3-(イミダゾ[1,2-b]ピリダジン-3-イルエチニル)-4-メチル-N-{4-[(4-メチルピペラジン-1-イル)メチル]-3-(トリフルオロメチル)フェニル}ベンズアミドおよびその一塩酸塩の結晶形 | ⤷ Sign Up |
Mexico | 2015007578 | FORMAS CRISTALINAS DE 3-(IMIDAZO[1,2-B] PIRIDAZIN-3-ILETINIL)-4-ME TIL-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.) | ⤷ Sign Up |
Portugal | 2495016 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ponatinib hydrochloride
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1973545 | 72/2013 | Austria | ⤷ Sign Up | PRODUCT NAME: PONATINIB; REGISTRATION NO/DATE: EU/1/13/839 20130701 |
1973545 | 13C0069 | France | ⤷ Sign Up | 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 | CA 2013 00066 | Denmark | ⤷ Sign Up | PRODUCT NAME: POATINIB, HERUNDER PONATINIB HYDROCHLORID; REG. NO/DATE: EU/1/13/839/001-004 20130701 |
1973545 | C 2013 039 | Romania | ⤷ Sign Up | PRODUCT NAME: PONATINIB SI SARURILE SALE ACCEPTABILE FARMACEUTIC; NATIONAL AUTHORISATION NUMBER: EU/1/13/839/001, EU/1/13/839/002, EU/1/13/839/003, EU/1/13/839/004; DATE OF NATIONAL AUTHORISATION: 20130701; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/839/001, EU/1/13/839/002, EU/1/13/839/003, EU/1/13/839/004; DATE OF FIRST AUTHORISATION IN EEA: 20130701 |
1973545 | CR 2013 00066 | Denmark | ⤷ Sign Up | 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 | ⤷ Sign Up | 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 | 151 5025-2013 | Slovakia | ⤷ Sign Up | (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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