Last Updated: November 13, 2026

Details for New Drug Application (NDA): 209299

NDA 209299 describes TAVALISSE, which is a drug marketed by Rigel Pharms and is included in one NDA. It is available from one supplier. There are fourteen patents protecting this drug. Additional details are available on the TAVALISSE profile page.

The generic ingredient in TAVALISSE is fostamatinib disodium. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the fostamatinib disodium profile page.

Summary for 209299

Tradename:	TAVALISSE
Applicant:	Rigel Pharms
Ingredient:	fostamatinib disodium
Patents:	14

Suppliers and Packaging for NDA: 209299

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299	NDA	Rigel Pharmaceuticals, Inc.	71332-001	71332-001-01	60 TABLET in 1 BOTTLE (71332-001-01)
TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299	NDA	Rigel Pharmaceuticals, Inc.	71332-002	71332-002-01	60 TABLET in 1 BOTTLE (71332-002-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 100MG BASE
Approval Date:	Apr 17, 2018	TE:	AB	RLD:	Yes
Patent:	⤷ Start Trial	Patent Expiration:	Sep 4, 2031	Product Flag?		Substance Flag?	Y	Delist Request?
Patent:	⤷ Start Trial	Patent Expiration:	Mar 28, 2026	Product Flag?		Substance Flag?	Y	Delist Request?
Patented Use:	TREATMENT OF THROMBOCYTOPENIA IN ADULT PATIENTS WITH CHRONIC IMMUNE THROMBOCYTOPENIA (ITP) WHO HAVE HAD AN INSUFFICIENT RESPONSE TO A PREVIOUS TREATMENT
Patent:	⤷ Start Trial	Patent Expiration:	Jun 12, 2026	Product Flag?		Substance Flag?	Y	Delist Request?
Patented Use:	TREATMENT OF THROMBOCYTOPENIA IN ADULT PATIENTS WITH CHRONIC IMMUNE THROMBOCYTOPENIA (ITP) WHO HAVE HAD AN INSUFFICIENT RESPONSE TO A PREVIOUS TREATMENT

Expired US Patents for NDA 209299

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Rigel Pharms	TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299-001	Apr 17, 2018	⤷ Start Trial	⤷ Start Trial
Rigel Pharms	TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299-002	Apr 17, 2018	⤷ Start Trial	⤷ Start Trial
Rigel Pharms	TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299-002	Apr 17, 2018	⤷ Start Trial	⤷ Start Trial
Rigel Pharms	TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299-002	Apr 17, 2018	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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