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 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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Questions you can ask:
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Summary for TAVALISSE
International Patents: | 118 |
US Patents: | 14 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 194 |
Clinical Trials: | 3 |
Patent Applications: | 2,071 |
Drug Prices: | Drug price information for TAVALISSE |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TAVALISSE |
What excipients (inactive ingredients) are in TAVALISSE? | TAVALISSE excipients list |
DailyMed Link: | TAVALISSE at DailyMed |


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
Sponsor | Phase |
---|---|
Holdsworth House Medical Practice | Phase 2 |
Washington University School of Medicine | Phase 2 |
Rigel Pharmaceuticals | Phase 2 |
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 ⤷ Try for Free.
This potential generic entry date is based on patent 8,771,648.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Rigel Pharms | TAVALISSE | fostamatinib disodium | TABLET;ORAL | 209299-002 | Apr 17, 2018 | RX | Yes | Yes | RE48898 | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Rigel Pharms | TAVALISSE | fostamatinib disodium | TABLET;ORAL | 209299-002 | Apr 17, 2018 | RX | Yes | Yes | 8,771,648 | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Rigel Pharms | TAVALISSE | fostamatinib disodium | TABLET;ORAL | 209299-001 | Apr 17, 2018 | RX | Yes | No | 9,283,238 | ⤷ Try for Free | ⤷ Try for Free | ||||
Rigel Pharms | TAVALISSE | fostamatinib disodium | TABLET;ORAL | 209299-002 | Apr 17, 2018 | RX | Yes | Yes | 9,283,238 | ⤷ Try for Free | ⤷ Try for Free | ||||
>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: ⤷ Try for Free
Australia
Patent: 12288632
Patent: New (trimethoxyphenylamino)pyrimidinyl formulations
Estimated Expiration: ⤷ Try for Free
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: ⤷ Try for Free
Canada
Patent: 43138
Patent: NOUVELLES FORMULATIONS DE (TRIMETHOXYPHENYLAMINO)PYRIMIDINYLE (NEW (TRIMETHOXYPHENYLAMINO)PYRIMIDINYL FORMULATIONS)
Estimated Expiration: ⤷ Try for Free
China
Patent: 3826610
Patent: New (trimethoxyphenylamino)pyrimidinyl formulations
Estimated Expiration: ⤷ Try for Free
Croatia
Patent: 0190186
Estimated Expiration: ⤷ Try for Free
Cyprus
Patent: 22596
Estimated Expiration: ⤷ Try for Free
Denmark
Patent: 36487
Estimated Expiration: ⤷ Try for Free
Eurasian Patent Organization
Patent: 8432
Patent: НОВЫЕ СОСТАВЫ НА ОСНОВЕ (ТРИМЕТОКСИФЕНИЛАМИНО)ПИРИМИДИНИЛОВ (NEW (TRIMETHOXYPHENYLAMINO)PYRIMIDINYL FORMULATIONS)
Estimated Expiration: ⤷ Try for Free
Patent: 1490363
Patent: НОВЫЕ СОСТАВЫ НА ОСНОВЕ (ТРИМЕТОКСИФЕНИЛАМИНО)ПИРИМИДИНИЛОВ
Estimated Expiration: ⤷ Try for Free
European Patent Office
Patent: 36487
Patent: NOUVELLES FORMULATIONS DE (TRIMÉTHOXYPHÉNYLAMINO)PYRIMIDINYLE (NEW (TRIMETHOXYPHENYLAMINO)PYRIMIDINYL FORMULATIONS)
Estimated Expiration: ⤷ Try for Free
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: ⤷ Try for Free
Hungary
Patent: 42611
Estimated Expiration: ⤷ Try for Free
Japan
Patent: 19116
Estimated Expiration: ⤷ Try for Free
Patent: 14521630
Estimated Expiration: ⤷ Try for Free
Lithuania
Patent: 36487
Estimated Expiration: ⤷ Try for Free
Mexico
Patent: 9685
Patent: FORMULACIONES DE (TRIMETOXIFENILAMINO) PIRIMIDINILO NUEVAS. (NEW (TRIMETHOXYPHENYLAMINO)PYRIMIDINYL FORMULATIONS.)
Estimated Expiration: ⤷ Try for Free
Patent: 14001065
Patent: FORMULACIONES DE (TRIMETOXIFENILAMINO) PIRIMIDILINO NUEVAS. (NEW (TRIMETHOXYPHENYLAMINO)PYRIMIDINYL FORMULATIONS.)
Estimated Expiration: ⤷ Try for Free
Poland
Patent: 36487
Estimated Expiration: ⤷ Try for Free
Portugal
Patent: 36487
Estimated Expiration: ⤷ Try for Free
Serbia
Patent: 433
Patent: NOVE FORMULACIJE (TRIMETOKSIFENILAMINO)PIRIMIDINILA (NEW (TRIMETHOXYPHENYLAMINO)PYRIMIDINYL FORMULATIONS)
Estimated Expiration: ⤷ Try for Free
Slovenia
Patent: 36487
Estimated Expiration: ⤷ Try for Free
South Korea
Patent: 2024120
Estimated Expiration: ⤷ Try for Free
Patent: 2090440
Estimated Expiration: ⤷ Try for Free
Patent: 140058576
Patent: NEW (TRIMETHOXYPHENYLAMINO)PYRIMIDINYL FORMULATIONS
Estimated Expiration: ⤷ Try for Free
Patent: 190109576
Patent: 신규한 피리미디닐 제형 (NEW TRIMETHOXYPHENYLAMINOPYRIMIDINYL FORMULATIONS)
Estimated Expiration: ⤷ Try for Free
Spain
Patent: 10423
Estimated Expiration: ⤷ Try for Free
Taiwan
Patent: 1311251
Patent: New (trimethoxyphenylamino) pyrimidinyl formulations
Estimated Expiration: ⤷ Try for Free
Turkey
Patent: 1901792
Estimated Expiration: ⤷ Try for Free
Uruguay
Patent: 223
Patent: FORMULACIONES DE (TRIMETOXIFENILAMINO)PIRIMIDINILO NUEVAS
Estimated Expiration: ⤷ Try for Free
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 |
---|---|---|---|
South Korea | 102090440 | ⤷ Try for Free | |
Eurasian Patent Organization | 028432 | НОВЫЕ СОСТАВЫ НА ОСНОВЕ (ТРИМЕТОКСИФЕНИЛАМИНО)ПИРИМИДИНИЛОВ (NEW (TRIMETHOXYPHENYLAMINO)PYRIMIDINYL FORMULATIONS) | ⤷ Try for Free |
China | 101115761 | Prodrugs of 2,4-pyrimidinediamine compounds and their uses | ⤷ Try for Free |
South Korea | 20190109576 | 신규한 피리미디닐 제형 (NEW TRIMETHOXYPHENYLAMINOPYRIMIDINYL FORMULATIONS) | ⤷ Try for Free |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TAVALISSE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1856135 | PA2020507 | Lithuania | ⤷ Try for Free | PRODUCT NAME: FOSTAMATINIBO DINATRIO HEKSAHIDRATAS; REGISTRATION NO/DATE: EU/1/19/1405 20200109 |
1856135 | 2020/017 | Ireland | ⤷ Try for Free | 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 | 122020000021 | Germany | ⤷ Try for Free | 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 | SPC/GB20/016 | United Kingdom | ⤷ Try for Free | 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; REGISTERED: UK EU/1/19/1405 (NI) 20200113; UK PLGB 12930/0022 20200113; UK PLGB 12930/0023 20200113 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory for TAVALISSE
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