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Last Updated: October 5, 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 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 fourteen patent family members in forty-four countries.

Summary for fostamatinib disodium
International Patents:114
US Patents:14
Tradenames:1
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 1
Clinical Trials: 19
Patent Applications: 568
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

Anatomical Therapeutic Chemical (ATC) Classes for fostamatinib disodium
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 Y 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
>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
Costa Rica 11476 GRANULACION EN HUMEDO UTILIZANDO UN AGENTE SECUESTRANTE DE AGUA See Plans and Pricing
World Intellectual Property Organization (WIPO) 2006078846 See Plans and Pricing
Brazil 112014001999 composição farmacêutica, forma de dosagem unitária, formulação de granulação a úmido, formulação de compactação por roletes, formulação de compressão direta, e, método para a preparação de uma composição farmacêutica 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 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 CA 2020 00018 Denmark 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; REG. NO/DATE: EU/1/19/1405 20200113
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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