FOSTAMATINIB DISODIUM - Generic Drug Details
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What are the generic drug sources for fostamatinib disodium and what is the scope of patent protection?
Fostamatinib disodium
is the generic ingredient in one branded drug marketed by Rigel Pharms Inc and is included in one NDA. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.Fostamatinib disodium has one hundred and sixteen patent family members in forty-five countries.
One supplier is listed for this compound.
Summary for FOSTAMATINIB DISODIUM
International Patents: | 116 |
US Patents: | 14 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 112 |
Clinical Trials: | 19 |
Patent Applications: | 518 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for FOSTAMATINIB DISODIUM |
DailyMed Link: | FOSTAMATINIB DISODIUM at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for FOSTAMATINIB DISODIUM
Generic Entry Date for FOSTAMATINIB DISODIUM*:
Constraining patent/regulatory exclusivity:
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 FOSTAMATINIB DISODIUM
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Rigel Pharmaceuticals | Phase 3 |
AstraZeneca | Phase 2 |
AstraZeneca | Phase 3 |
Paragraph IV (Patent) Challenges for FOSTAMATINIB DISODIUM
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
TAVALISSE | Tablets | fostamatinib disodium | 100 mg and 150 mg | 209299 | 1 | 2022-04-18 |
US Patents and Regulatory Information for FOSTAMATINIB DISODIUM
International Patents for FOSTAMATINIB DISODIUM
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 1856135 | PROMEDICAMENTS DE COMPOSES DE 2,4-PYRIMIDINEDIAMINE ET LEURS UTILISATIONS (PRODRUGS OF 2,4-PYRIMIDINEDIAMINE COMPOUNDS AND THEIR USES) | ⤷ Try a Trial |
Netherlands | 301039 | ⤷ Try a Trial | |
China | 101998857 | Wet granulation using a water sequestering agent | ⤷ Try a Trial |
Hong Kong | 1108896 | PRODRUGS OF 2,4-PYRIMIDINEDIAMINE COMPOUNDS AND THEIR USES | ⤷ Try a Trial |
Lithuania | 2217241 | ⤷ Try a Trial | |
Japan | 5264759 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for FOSTAMATINIB DISODIUM
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1856135 | 20C1019 | France | ⤷ Try a Trial | PRODUCT NAME: FOSTAMATINIB ET/OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES OU HYDRATE OU SOLVATE DU FOSTAMATINIB, EN PARTICULIER UN SEL DISODIQUE DE FOSTAMATINIB TEL QUE LE FOSTAMATINIB DISODIQUE HEXAHYDRATE; NAT. REGISTRATION NO/DATE: EU/1/19/1405 20200109; FIRST REGISTRATION: NL - EU/1/19/1405 20200109 |
1856135 | C202030021 | Spain | ⤷ Try a Trial | PRODUCT NAME: FOSTAMATINIB O UNA SAL FARMACEUTICAMENTE ACEPTABLE DE FOSTAMATINIB, O UN HIDRATO, O UN SOLVATO, O N-OXIDO DEL FOSTAMATINIB O UNA SAL, PREFERENTEMENTE FOSTAMATINIB DISODICO Y, OPCIONALMENTE, EN FORMA DE HIDRATO; NATIONAL AUTHORISATION NUMBER: EU/1/19/1405; DATE OF AUTHORISATION: 20200109; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/19/1405; DATE OF FIRST AUTHORISATION IN EEA: 20200109 |
1856135 | 2020/017 | Ireland | ⤷ Try a Trial | PRODUCT NAME: FOSTAMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, OR A HYDRATE, SOLVATE OR N-OXIDE OF FOSTAMATINIB OR THE PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, ESPECIALLY FOSTAMATINIB DISODIUM, OPTIONALLY IN FORM OF A HYDRATE; REGISTRATION NO/DATE: EU/1/19/1405 20200113 |
1856135 | 301039 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: FOSTAMATINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN FOSTAMATINIB, OF EEN HYDRAAT, SOLVAAT OF N-OXIDE VAN FOSTAMATINIB OF HET FARMACEUTISCH AANVAARDBARE ZOUT VAN FOSTAMATINIB, IN HET BIJZONDER DINATRIUMFOSTAMATINIB EVENTUEEL IN DE VORM VAN EEN HYDRAAT; REGISTRATION NO/DATE: EU/1/19/1405 20200113 |
1856135 | C 2020 014 | Romania | ⤷ Try a Trial | PRODUCT NAME: SUPPLEMENTARY PROTECTION CERTIFICATE; NATIONAL AUTHORISATION NUMBER: C 2020 014; DATE OF NATIONAL AUTHORISATION: RO; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 1856135; DATE OF FIRST AUTHORISATION IN EEA: 20220530 |
1856135 | 2090014-8 | Sweden | ⤷ Try a Trial | PRODUCT NAME: FOSTAMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, OR A HYDRATE OR SOLVATE OF FOSTAMATINIB OR THE PH ARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, ESPECIALLY FOSTAMATINIB DISODIUM, OPTIONALLY IN FORM OF A HYDRATE; REG. NO/DATE: EU/1/19/1405 20200113 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |