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TAVALISSE Drug Profile

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When do Tavalisse patents expire, and when can generic versions of Tavalisse launch?

Tavalisse is a drug marketed by Rigel Pharms Inc and is included in one NDA. There are fourteen patents protecting this drug.

This drug has one hundred and six patent family members in forty-one countries.

The generic ingredient in TAVALISSE is fostamatinib disodium. Additional details are available on the fostamatinib disodium profile page.

US ANDA Litigation and Generic Entry Outlook for Tavalisse

Tavalisse will be eligible for patent challenges on April 17, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 27, 2032. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for TAVALISSE

International Patents:	106
US Patents:	14
Applicants:	1
NDAs:	1
Bulk Api Vendors:	69
Patent Applications:	67
Drug Prices:	Drug price information for TAVALISSE
DailyMed Link:	TAVALISSE at DailyMed

See drug prices for TAVALISSE

Generic Entry Opportunity Date for TAVALISSE

NDA:

209299

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.

Synonyms for TAVALISSE

(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 dihydrogen phosphate

[6-({5-Fluoro-2-[(3,4,5-Trimethoxyphenyl)amino]pyrimidin-4-Yl}amino)-2,2-Dimethyl-3-Oxo-2,3-Dihydro-4h-Pyrido[3,2-B][1,4]oxazin-4-Yl]methyl Dihydrogen Phosphate

[6-[[5-fluoro-2-(3,4,5-trimethoxyanilino)pyrimidin-4-yl]amino]-2,2-dimethyl-3-oxo-pyrido[3,2-b][1,4]oxazin-4-yl]methyl dihydrogen phosphate

[6-[[5-fluoro-2-(3,4,5-trimethoxyanilino)pyrimidin-4-yl]amino]-2,2-dimethyl-3-oxopyrido[3,2-b][1,4]oxazin-4-yl]methyl dihydrogen phosphate

[6-[[5-fluoro-2-[(3,4,5-trimethoxyphenyl)amino]pyrimidin-4-yl]amino]-2,2-dimethyl-3-oxopyrido[2,3-e][1,4]oxazin-4-yl]methyl dihydrogen phosphate

2H-Pyrido(3,2-b)-1,4-oxazin-3(4H)-one, 6-((5-fluoro-2-((3,4,5-trimethoxyphenyl)amino)-4-pyrimidinyl)amino)-2,2-dimethyl-4-((phosphonooxy)methyl)-

2H-Pyrido[3,2-b]-1,4-oxazin-3(4H)-one, 6-((5-fluoro-2-((3,4,5-trimethoxyphenyl)amino)-4-pyrimidinyl)amino)-2,2-dimethyl-4-((phosphonooxy)methyl)-

2H-Pyrido[3,2-b]-1,4-oxazin-3(4H)-one, 6-[[5-fluoro-2-[(3,4,5-trimethoxyphenyl)amino]-4-pyrimidinyl]amino]-2,2-dimethyl-4-[(phosphonooxy)methyl]-

2RC

4CA-0549

6-((5-Fluoro-2-((3,4,5-trimethoxyphenyl)amino)-4-pyrimidinyl)amino)-2,2-dimethyl-4-((phosphonooxy)methyl)-2h-pyrido(3,2-b)-1,4-oxazi n-3(4h)-one

6-[[5-fluoro-2-[(3,4,5-trimethoxyphenyl)amino]-4-pyrimidinyl]amino]-2,2-dimethyl-4-[(phosphonooxy)methyl]-2H-pyrido[3,2-b]-1,4-oxazin-3(4H)-one

901119-35-5

A11926

AB0008135

ABP000970

AC-30126

AK174913

AKOS025404920

AM81257

AS-56399

BCP01871

BCP9000704

BCPP000226

BDBM50431381

CHEMBL2103830

CS-2152

D09347

DB12010

EX-A108

Fostamatinib

Fostamatinib (R788)

Fostamatinib (USAN)

Fostamatinib [USAN:INN]

Fostamatinib(R788)

Fostamatinib/R788

FT-0699180

GKDRMWXFWHEQQT-UHFFFAOYSA-N

GTPL7796

HMS3651H09

HY-13038A

J-517972

KS-00000XGF

NCGC00346622-01

PB25570

Q-4555

Q5473550

QCR-82

R 788

R-788

R-788 Free acid

R-935788

R-935788 Free acid

R788

R788 (Fostamatinib)

R788;R7935788;R 788;R 7935788;R-788;R-7935788

R7935788

s2625

SC-47719

SCHEMBL1201371

SQ8A3S5101

SW219234-1

UNII-SQ8A3S5101

VA12036

ZINC43131420

US Patents and Regulatory Information for TAVALISSE

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

International Patents for TAVALISSE

Country	Patent Number	Estimated Expiration
Argentina	087371
China	101998857
Japan	2010510322
South Korea	20140058576
China	101115761
Turkey	201807879
Canada	2704474

Supplementary Protection Certificates for TAVALISSE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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