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Last Updated: June 4, 2020

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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

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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
Drug patent expirations by year for TAVALISSE
Drug Prices for TAVALISSE

See drug prices for TAVALISSE

Generic Entry Opportunity Date for TAVALISSE
Generic Entry Date for TAVALISSE*:
Constraining patent/regulatory exclusivity:
NDA:
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   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 209299-001 Apr 17, 2018 RX Yes No   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   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
>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 TAVALISSE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Medtronic
Dow
McKinsey
Baxter
Harvard Business School

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.