Fostamatinib disodium - Generic Drug Details

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 eighteen patent family members in forty-five countries.

One supplier is listed for this compound.

Summary for fostamatinib disodium

International Patents:	118
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

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

See all fostamatinib disodium clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for fostamatinib disodium

B02BX	Other systemic hemostatics
B02B	VITAMIN K AND OTHER HEMOSTATICS
B02	ANTIHEMORRHAGICS
B	Blood and blood forming organs

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
Rigel Pharms Inc	TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299-001	Apr 17, 2018		RX	Yes	No				Y
Rigel Pharms Inc	TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299-002	Apr 17, 2018		RX	Yes	Yes
Rigel Pharms Inc	TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299-001	Apr 17, 2018		RX	Yes	No				Y
Rigel Pharms Inc	TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299-001	Apr 17, 2018		RX	Yes	No				Y
Rigel Pharms Inc	TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299-002	Apr 17, 2018		RX	Yes	Yes				Y

International Patents for fostamatinib disodium

Country	Patent Number	Title	Estimated Expiration
Australia	2006206458	Prodrugs of 2,4-pyrimidinediamine compounds and their uses
World Intellectual Property Organization (WIPO)	2008064274
Netherlands	301039
Portugal	2736487
New Zealand	585913	Formulations and tablets comprising (6-(5-fluoro-2-(3,4,5-trimethoxyphenylamino)pyrimidin-4-ylamino)-2,2-dimethyl-3-oxo-2H-pyrido[3,2-b][1,4]oxazin-4(3H)-yl)methyl phosphate (fostamatinib) disodium salt
Poland	2217241

Supplementary Protection Certificates for fostamatinib disodium

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1856135	CA 2020 00018	Denmark		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	C202030021	Spain		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	2020C/511	Belgium		PRODUCT NAME: TAVLESSE - FOSTAMATINIB; AUTHORISATION NUMBER AND DATE: EU/1/19/1405 20200113
1856135	PA2020507	Lithuania		PRODUCT NAME: FOSTAMATINIBO DINATRIO HEKSAHIDRATAS; REGISTRATION NO/DATE: EU/1/19/1405 20200109
1856135	132020000000046	Italy		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	301039	Netherlands		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