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Last Updated: October 25, 2020

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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 ten patent family members in forty-one countries.

Summary for fostamatinib disodium
International Patents:110
US Patents:14
Tradenames:1
Applicants:1
NDAs:1
Bulk Api Vendors: 53
Clinical Trials: 18
Patent Applications: 8
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

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

Supplementary Protection Certificates for fostamatinib disodium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1856135 CA 2020 00018 Denmark   Start 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; REG. NO/DATE: EU/1/19/1405 20200113
1856135 PA2020507 Lithuania   Start Trial PRODUCT NAME: FOSTAMATINIBO DINATRIO HEKSAHIDRATAS; REGISTRATION NO/DATE: EU/1/19/1405 20200109
1856135 132020000000046 Italy   Start Trial PRODUCT NAME: FOSTAMATINIB O SUO SALE FARMACEUTICAMENTE ACCETTABILE O IDRATO, SOLVATO O N-OSSIDO DI FOSTAMATINIB O DI SUO SALE FARMACEUTICAMENTE ACCETTABILE, IN PARTICOLARE FOSTAMATINIB DISODICO, FACOLTATIVAMENTE NELLA SUA FORMA IDRATA(TAVLESSE - FOSTAMATINIB); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1405, 20200113
1856135 LUC00153 Luxembourg   Start Trial 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 301039 Netherlands   Start 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 122020000021 Germany   Start Trial PRODUCT NAME: FOSTAMATINIB; PHARMAZEUTISCH ANNEHMBARES SALZ VON FOSTAMATINIB; HYDRAT, SOVAT ODER N-OXID VON FOSTAMATINIB ODER DES PHARMAZEUTISCH ANNEHMBAREN SALZES VON FOSTAMATINIB; DINATRIUM-FOSTAMATINIB; DINATRIUM-FOSTAMATINIB-HYDRAT; REGISTRATION NO/DATE: EU/1/19/1405 20200109
1856135 2020C/511 Belgium   Start Trial 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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Serving leading biopharmaceutical companies globally:

Harvard Business School
Medtronic
McKesson
Merck
Boehringer Ingelheim
Moodys

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