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Last Updated: March 29, 2024

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.

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

SponsorPhase
Rigel PharmaceuticalsPhase 3
AstraZenecaPhase 2
AstraZenecaPhase 3

See all FOSTAMATINIB DISODIUM clinical trials

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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Rigel Pharms Inc TAVALISSE fostamatinib disodium TABLET;ORAL 209299-001 Apr 17, 2018 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Rigel Pharms Inc TAVALISSE fostamatinib disodium TABLET;ORAL 209299-002 Apr 17, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Rigel Pharms Inc TAVALISSE fostamatinib disodium TABLET;ORAL 209299-002 Apr 17, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Rigel Pharms Inc TAVALISSE fostamatinib disodium TABLET;ORAL 209299-001 Apr 17, 2018 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Rigel Pharms Inc TAVALISSE fostamatinib disodium TABLET;ORAL 209299-001 Apr 17, 2018 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Rigel Pharms Inc TAVALISSE fostamatinib disodium TABLET;ORAL 209299-002 Apr 17, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a 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 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

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