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Last Updated: February 26, 2021

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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 eleven patent family members in forty-two 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:111
US Patents:14
Applicants:1
NDAs:1
Bulk Api Vendors: 71
Clinical Trials: 1
Patent Applications: 1,148
Drug Prices: Drug price information for TAVALISSE
DailyMed Link:TAVALISSE at DailyMed
Drug patent expirations by year for TAVALISSE
Drug Prices for TAVALISSE

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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.

Recent Clinical Trials for TAVALISSE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Washington University School of MedicinePhase 2
Rigel PharmaceuticalsPhase 2

See all TAVALISSE clinical trials

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
>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 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 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 2020/017 Ireland   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; REGISTRATION NO/DATE: EU/1/19/1405 20200113
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 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 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.