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
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: | 217 |
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 |
Anatomical Therapeutic Chemical (ATC) Classes for TAVALISSE
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 a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Prodrugs of 2,4-pyrimidinediamine compounds and their uses
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Wet granulation using a water sequestering agent
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Prodrugs of 2,4-pyrimidinediamine compounds and their uses
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Wet granulation using a water sequestering agent
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
(Trimethoxyphenylamino) pyrimidinyl formulations
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Prodrugs of 2,4-pyrimidinediamine compounds and their uses
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Rigel Pharms Inc | TAVALISSE | fostamatinib disodium | TABLET;ORAL | 209299-002 | Apr 17, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Rigel Pharms Inc | TAVALISSE | fostamatinib disodium | TABLET;ORAL | 209299-001 | Apr 17, 2018 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>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: ⤷ Try a Trial
Australia
Patent: 12288632
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2014001999
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 43138
Estimated Expiration: ⤷ Try a Trial
China
Patent: 3826610
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0190186
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 22596
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 36487
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 8432
Estimated Expiration: ⤷ Try a Trial
Patent: 1490363
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 36487
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 98741
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 42611
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 19116
Estimated Expiration: ⤷ Try a Trial
Patent: 14521630
Estimated Expiration: ⤷ Try a Trial
Lithuania
Patent: 36487
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 9685
Estimated Expiration: ⤷ Try a Trial
Patent: 14001065
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 36487
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 36487
Estimated Expiration: ⤷ Try a Trial
Serbia
Patent: 433
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 36487
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 2024120
Estimated Expiration: ⤷ Try a Trial
Patent: 2090440
Estimated Expiration: ⤷ Try a Trial
Patent: 140058576
Estimated Expiration: ⤷ Try a Trial
Patent: 190109576
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 10423
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 1311251
Estimated Expiration: ⤷ Try a Trial
Turkey
Patent: 1901792
Estimated Expiration: ⤷ Try a Trial
Uruguay
Patent: 223
Estimated Expiration: ⤷ Try a Trial
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 |
---|---|---|---|
Colombia | 6280491 | GRANULACION EN HUMEDO QUE UTILIZA SECUESTRANTE DE AGUA | ⤷ Try a Trial |
Mexico | 339685 | FORMULACIONES DE (TRIMETOXIFENILAMINO) PIRIMIDINILO NUEVAS. (NEW (TRIMETHOXYPHENYLAMINO)PYRIMIDINYL FORMULATIONS.) | ⤷ Try a Trial |
Canada | 2673137 | PROMEDICAMENTS DE COMPOSES DE 2,4-PYRIMIDINEDIAMINE ET LEURSUTILISATIONS (PRODRUG SALTS OF 2, 4-PYRIMIDINEDIAMINE COMPOUNDS AND THEIR USES) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TAVALISSE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1856135 | LUC00153 | Luxembourg | ⤷ Try a 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 |
1856135 | C202030021 | Spain | ⤷ Try a Trial | PRODUCT NAME: FOSTAMATINIB O UNA SAL FARMACEUTICAMENTE ACEPTABLE DE FOSTAMATINIB, O UN HIDRATO, O UN SOLVATO, O N-OXIDO DEL FOSTAMATINIB O UNA SAL, PREFERENTEMENTE FOSTAMATINIB DISODICO Y, OPCIONALMENTE, EN FORMA DE HIDRATO; NATIONAL AUTHORISATION NUMBER: EU/1/19/1405; DATE OF AUTHORISATION: 20200109; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/19/1405; DATE OF FIRST AUTHORISATION IN EEA: 20200109 |
1856135 | 2020C/511 | Belgium | ⤷ Try a Trial | PRODUCT NAME: TAVLESSE - FOSTAMATINIB; AUTHORISATION NUMBER AND DATE: EU/1/19/1405 20200113 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |