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Last Updated: May 25, 2022

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.

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

The generic ingredient in TAVALISSE is fostamatinib disodium. 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.

Indicators of Generic Entry

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Summary for TAVALISSE
International Patents:114
US Patents:14
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 80
Clinical Trials: 3
Patent Applications: 90
Drug Prices: Drug price information for TAVALISSE
What excipients (inactive ingredients) are in TAVALISSE?TAVALISSE excipients list
DailyMed Link:TAVALISSE at DailyMed
Drug patent expirations by year for TAVALISSE
Drug Prices for TAVALISSE

See drug prices for TAVALISSE

DrugPatentWatch® Estimated 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
Holdsworth House Medical PracticePhase 2
Washington University School of MedicinePhase 2
Rigel PharmaceuticalsPhase 2

See all TAVALISSE clinical trials

US Patents and Regulatory Information for TAVALISSE

TAVALISSE is protected by fourteen US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TAVALISSE is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Prodrugs of 2,4-pyrimidinediamine compounds and their uses
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Wet granulation using a water sequestering agent
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Prodrugs of 2,4-pyrimidinediamine compounds and their uses
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Wet granulation using a water sequestering agent
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

(Trimethoxyphenylamino) pyrimidinyl formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Prodrugs of 2,4-pyrimidinediamine compounds and their uses
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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: See Plans and Pricing

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Rigel Pharms Inc TAVALISSE fostamatinib disodium TABLET;ORAL 209299-002 Apr 17, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Rigel Pharms Inc TAVALISSE fostamatinib disodium TABLET;ORAL 209299-002 Apr 17, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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
Estimated Expiration: See Plans and Pricing

Australia

Patent: 12288632
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2014001999
Estimated Expiration: See Plans and Pricing

Canada

Patent: 43138
Estimated Expiration: See Plans and Pricing

China

Patent: 3826610
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0190186
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 36487
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 8432
Estimated Expiration: See Plans and Pricing

Patent: 1490363
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 36487
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 98741
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 42611
Estimated Expiration: See Plans and Pricing

Japan

Patent: 19116
Estimated Expiration: See Plans and Pricing

Patent: 14521630
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 36487
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 9685
Estimated Expiration: See Plans and Pricing

Patent: 14001065
Estimated Expiration: See Plans and Pricing

Poland

Patent: 36487
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 36487
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 433
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 36487
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 2024120
Estimated Expiration: See Plans and Pricing

Patent: 2090440
Estimated Expiration: See Plans and Pricing

Patent: 140058576
Estimated Expiration: See Plans and Pricing

Patent: 190109576
Estimated Expiration: See Plans and Pricing

Spain

Patent: 10423
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 1311251
Estimated Expiration: See Plans and Pricing

Turkey

Patent: 1901792
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 223
Estimated Expiration: See Plans and Pricing

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
Denmark 1856135 See Plans and Pricing
Nicaragua 201000078 GRANULACIÓN EN HÚMEDO QUE UTILIZA UN AGENTE SECUESTRANTE DE AGUA. See Plans and Pricing
Japan 2014521630 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TAVALISSE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1856135 C20200009 00319 Estonia See Plans and Pricing PRODUCT NAME: FOSTAMATINIIB;REG NO/DATE: EU/1/19/1405 13.01.2020
1856135 PA2020507 Lithuania See Plans and Pricing PRODUCT NAME: FOSTAMATINIBO DINATRIO HEKSAHIDRATAS; REGISTRATION NO/DATE: EU/1/19/1405 20200109
1856135 LUC00153 Luxembourg See Plans and Pricing 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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Dow
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Baxter
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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.