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Last Updated: November 29, 2022

Fostamatinib disodium - Generic Drug Details


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What are the generic drug sources for fostamatinib disodium and what is the scope of freedom to operate?

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 fifteen patent family members in forty-four countries.

Summary for fostamatinib disodium
International Patents:115
US Patents:14
Tradenames:1
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 1
Clinical Trials: 19
Patent Applications: 644
DailyMed Link:fostamatinib disodium at DailyMed
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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Rigel Pharms Inc TAVALISSE fostamatinib disodium TABLET;ORAL 209299-002 Apr 17, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Rigel Pharms Inc TAVALISSE fostamatinib disodium TABLET;ORAL 209299-001 Apr 17, 2018 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Rigel Pharms Inc TAVALISSE fostamatinib disodium TABLET;ORAL 209299-002 Apr 17, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Rigel Pharms Inc TAVALISSE fostamatinib disodium TABLET;ORAL 209299-002 Apr 17, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Rigel Pharms Inc TAVALISSE fostamatinib disodium TABLET;ORAL 209299-002 Apr 17, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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
Serbia 58433 NOVE FORMULACIJE (TRIMETOKSIFENILAMINO)PIRIMIDINILA (NEW (TRIMETHOXYPHENYLAMINO)PYRIMIDINYL FORMULATIONS) See Plans and Pricing
Croatia P20181174 See Plans and Pricing
Austria 540041 See Plans and Pricing
Eurasian Patent Organization 201070570 ВЛАЖНОЕ ГРАНУЛИРОВАНИЕ С ИСПОЛЬЗОВАНИЕМ ВЕЩЕСТВА, СВЯЗЫВАЮЩЕГО ВОДУ See Plans and Pricing
Brazil PI0820389 Formulação granulada usando um agente sequestrador de água See Plans and Pricing
Canada 2843138 NOUVELLES FORMULATIONS DE (TRIMETHOXYPHENYLAMINO)PYRIMIDINYLE (NEW (TRIMETHOXYPHENYLAMINO)PYRIMIDINYL FORMULATIONS) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for fostamatinib disodium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1856135 301039 Netherlands See Plans and Pricing 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 PA2020507,C1856135 Lithuania See Plans and Pricing PRODUCT NAME: FOSTAMATINIBO DINATRIO HEKSAHIDRATAS; REGISTRATION NO/DATE: EU/1/19/1405 20200109
1856135 2020/017 Ireland See Plans and Pricing 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 C202030021 Spain See Plans and Pricing 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 LUC00153 Luxembourg See Plans and Pricing PRODUCT NAME: FOSTAMATINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE FOSTAMATINIB, OU UN HYDRATE, SOLVATE OU N-OXYDE DE FOSTAMATINIB OU LE SEL PHARMACEUTIQUEMENT ACCEPTABLE DE FOSTAMATINIB, EN PARTICULIER FOSTAMATINIB DISODIUM, EVENTUELLEMENT SOUS FORME D'HYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/19/1405 20200113
1856135 2020C/511 Belgium See Plans and Pricing PRODUCT NAME: TAVLESSE - FOSTAMATINIB; AUTHORISATION NUMBER AND DATE: EU/1/19/1405 20200113
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Moodys

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