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Last Updated: July 19, 2024

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TAVALISSE Drug Patent 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 and one Paragraph IV challenge.

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

The generic ingredient in TAVALISSE is fostamatinib disodium. One supplier is listed for this compound. Additional details are available on the fostamatinib disodium profile page.

DrugPatentWatch® Generic Entry Outlook for Tavalisse

Tavalisse was eligible for patent challenges on April 17, 2022.

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.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for TAVALISSE
Drug Prices for TAVALISSE

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
Holdsworth House Medical PracticePhase 2
Washington University School of MedicinePhase 2
Rigel PharmaceuticalsPhase 2

See all TAVALISSE clinical trials

Paragraph IV (Patent) Challenges for TAVALISSE
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 TAVALISSE

TAVALISSE is protected by fourteen US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TAVALISSE is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting TAVALISSE

Prodrugs of 2,4-pyrimidinediamine compounds and their uses
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Prodrugs of 2,4-pyrimidinediamine compounds and their uses
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF THROMBOCYTOPENIA IN ADULT PATIENTS WITH CHRONIC IMMUNE THROMBOCYTOPENIA (ITP) WHO HAVE HAD AN INSUFFICIENT RESPONSE TO A PREVIOUS TREATMENT

Prodrugs of 2,4-pyrimidinediamine compounds and their uses
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF THROMBOCYTOPENIA IN ADULT PATIENTS WITH CHRONIC IMMUNE THROMBOCYTOPENIA (ITP) WHO HAVE HAD AN INSUFFICIENT RESPONSE TO A PREVIOUS TREATMENT

Prodrugs of 2,4-pyrimidinediamine compounds and their uses
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF THROMBOCYTOPENIA IN ADULT PATIENTS WITH CHRONIC IMMUNE THROMBOCYTOPENIA (ITP) WHO HAVE HAD AN INSUFFICIENT RESPONSE TO A PREVIOUS TREATMENT

Prodrugs of 2,4-pyrimidinediamine compounds and their uses
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Wet granulation using a water sequestering agent
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Prodrugs of 2,4-pyrimidinediamine compounds and their uses
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Wet granulation using a water sequestering agent
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

(Trimethoxyphenylamino) pyrimidinyl formulations
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Prodrugs of 2,4-pyrimidinediamine compounds and their uses
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF THROMBOCYTOPENIA IN ADULT PATIENTS WITH CHRONIC IMMUNE THROMBOCYTOPENIA (ITP) WHO HAVE HAD AN INSUFFICIENT RESPONSE TO A PREVIOUS TREATMENT

(trimethoxyphenylamino) pyrimidinyl formulations
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF THROMBOCYTOPENIA IN ADULT PATIENTS WITH CHRONIC IMMUNE THROMBOCYTOPENIA (ITP) WHO HAVE HAD AN INSUFFICIENT RESPONSE TO A PREVIOUS TREATMENT

Prodrugs of 2,4-pyrimidinediamine compounds and their uses
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF THROMBOCYTOPENIA IN ADULT PATIENTS WITH CHRONIC IMMUNE THROMBOCYTOPENIA (ITP) WHO HAVE HAD AN INSUFFICIENT RESPONSE TO A PREVIOUS TREATMENT

Prodrugs of 2,4-pyrimidinediamine compounds and their uses
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF THROMBOCYTOPENIA IN ADULT PATIENTS WITH CHRONIC IMMUNE THROMBOCYTOPENIA (ITP) WHO HAVE HAD AN INSUFFICIENT RESPONSE TO A PREVIOUS TREATMENT

Prodrugs of 2,4-pyrimidinediamine compounds and their uses
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

FDA Regulatory Exclusivity protecting TAVALISSE

FOR THE TREATMENT OF THROMBOCYTOPENIA IN ADULT PATIENTS WITH CHRONIC IMMUNE THROMBOCYTOPENIA (ITP) WHO HAVE HAD AN INSUFFICIENT RESPONSE TO A PREVIOUS TREATMENT
Exclusivity Expiration: ⤷  Sign Up

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 ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Rigel Pharms Inc TAVALISSE fostamatinib disodium TABLET;ORAL 209299-002 Apr 17, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Rigel Pharms Inc TAVALISSE fostamatinib disodium TABLET;ORAL 209299-001 Apr 17, 2018 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Rigel Pharms Inc TAVALISSE fostamatinib disodium TABLET;ORAL 209299-002 Apr 17, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Rigel Pharms Inc TAVALISSE fostamatinib disodium TABLET;ORAL 209299-002 Apr 17, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Rigel Pharms Inc TAVALISSE fostamatinib disodium TABLET;ORAL 209299-001 Apr 17, 2018 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for TAVALISSE

When does loss-of-exclusivity occur for TAVALISSE?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 7371
Patent: FORMULACIONES DE (TRIMETOXIFENILAMINO)PIRIMIDINILO, METODOS
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 12288632
Patent: New (trimethoxyphenylamino)pyrimidinyl formulations
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2014001999
Patent: composição farmacêutica, forma de dosagem unitária, formulação de granulação a úmido, formulação de compactação por roletes, formulação de compressão direta, e, método para a preparação de uma composição farmacêutica
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 43138
Patent: NOUVELLES FORMULATIONS DE (TRIMETHOXYPHENYLAMINO)PYRIMIDINYLE (NEW (TRIMETHOXYPHENYLAMINO)PYRIMIDINYL FORMULATIONS)
Estimated Expiration: ⤷  Sign Up

China

Patent: 3826610
Patent: New (trimethoxyphenylamino)pyrimidinyl formulations
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0190186
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 22596
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 36487
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 8432
Patent: НОВЫЕ СОСТАВЫ НА ОСНОВЕ (ТРИМЕТОКСИФЕНИЛАМИНО)ПИРИМИДИНИЛОВ (NEW (TRIMETHOXYPHENYLAMINO)PYRIMIDINYL FORMULATIONS)
Estimated Expiration: ⤷  Sign Up

Patent: 1490363
Patent: НОВЫЕ СОСТАВЫ НА ОСНОВЕ (ТРИМЕТОКСИФЕНИЛАМИНО)ПИРИМИДИНИЛОВ
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 36487
Patent: NOUVELLES FORMULATIONS DE (TRIMÉTHOXYPHÉNYLAMINO)PYRIMIDINYLE (NEW (TRIMETHOXYPHENYLAMINO)PYRIMIDINYL FORMULATIONS)
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 98741
Patent: 新的 三甲氧基苯氨基 嘧啶基配製品 (NEW (TRIMETHOXYPHENYLAMINO)PYRIMIDINYL FORMULATIONS ())
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 42611
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 19116
Estimated Expiration: ⤷  Sign Up

Patent: 14521630
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 36487
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 9685
Patent: FORMULACIONES DE (TRIMETOXIFENILAMINO) PIRIMIDINILO NUEVAS. (NEW (TRIMETHOXYPHENYLAMINO)PYRIMIDINYL FORMULATIONS.)
Estimated Expiration: ⤷  Sign Up

Patent: 14001065
Patent: FORMULACIONES DE (TRIMETOXIFENILAMINO) PIRIMIDILINO NUEVAS. (NEW (TRIMETHOXYPHENYLAMINO)PYRIMIDINYL FORMULATIONS.)
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 36487
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 36487
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 433
Patent: NOVE FORMULACIJE (TRIMETOKSIFENILAMINO)PIRIMIDINILA (NEW (TRIMETHOXYPHENYLAMINO)PYRIMIDINYL FORMULATIONS)
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 36487
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 2024120
Estimated Expiration: ⤷  Sign Up

Patent: 2090440
Estimated Expiration: ⤷  Sign Up

Patent: 140058576
Patent: NEW (TRIMETHOXYPHENYLAMINO)PYRIMIDINYL FORMULATIONS
Estimated Expiration: ⤷  Sign Up

Patent: 190109576
Patent: 신규한 피리미디닐 제형 (NEW TRIMETHOXYPHENYLAMINOPYRIMIDINYL FORMULATIONS)
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 10423
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 1311251
Patent: New (trimethoxyphenylamino) pyrimidinyl formulations
Estimated Expiration: ⤷  Sign Up

Turkey

Patent: 1901792
Estimated Expiration: ⤷  Sign Up

Uruguay

Patent: 223
Patent: FORMULACIONES DE (TRIMETOXIFENILAMINO)PIRIMIDINILO NUEVAS
Estimated Expiration: ⤷  Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TAVALISSE around the world.

Country Patent Number Title Estimated Expiration
Brazil PI0606318 composto, composição, e, uso de um composto ⤷  Sign Up
Australia 2012288632 New (trimethoxyphenylamino)pyrimidinyl formulations ⤷  Sign Up
South Korea 20190109576 신규한 피리미디닐 제형 (NEW TRIMETHOXYPHENYLAMINOPYRIMIDINYL FORMULATIONS) ⤷  Sign Up
Japan 2008527048 ⤷  Sign Up
Hungary E039193 ⤷  Sign Up
Israel 183890 PRODRUGS OF 2,4-PYRIMIDINEDIAMINE COMPOUNDS AND THEIR USES ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TAVALISSE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1856135 122020000021 Germany ⤷  Sign Up PRODUCT NAME: FOSTAMATINIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ, HYDRAT UND/ODER SOLVAT DAVON, INSBESONDERE DINATRIUM-FOSTAMATINIB-HEXAHYDRAT; REGISTRATION NO/DATE: EU/1/19/1405 20200109
1856135 C 2020 014 Romania ⤷  Sign Up PRODUCT NAME: SUPPLEMENTARY PROTECTION CERTIFICATE; NATIONAL AUTHORISATION NUMBER: C 2020 014; DATE OF NATIONAL AUTHORISATION: RO; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 1856135; DATE OF FIRST AUTHORISATION IN EEA: 20220530
1856135 132020000000046 Italy ⤷  Sign Up 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 2020C/511 Belgium ⤷  Sign Up PRODUCT NAME: TAVLESSE - FOSTAMATINIB; AUTHORISATION NUMBER AND DATE: EU/1/19/1405 20200113
1856135 301039 Netherlands ⤷  Sign Up 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 PA2020507 Lithuania ⤷  Sign Up PRODUCT NAME: FOSTAMATINIBO DINATRIO HEKSAHIDRATAS; REGISTRATION NO/DATE: EU/1/19/1405 20200109
>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.