tavalisse Drug Patent Profile
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When do Tavalisse patents expire, and what generic alternatives are available?
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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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: | 1,140 |
| 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
*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 ⤷ 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 | |||
| >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 |
|---|---|---|---|
| Japan | 2008527048 | ⤷ Sign Up | |
| Australia | 2012288632 | New (trimethoxyphenylamino)pyrimidinyl formulations | ⤷ Sign Up |
| Eurasian Patent Organization | 020210 | ВЛАЖНОЕ ГРАНУЛИРОВАНИЕ С ИСПОЛЬЗОВАНИЕМ ВЕЩЕСТВА, СВЯЗЫВАЮЩЕГО ВОДУ (WET GRANULATION USING A WATER SEQUESTERING AGENT) | ⤷ Sign Up |
| Mexico | 2007007189 | PRODROGAS DE COMPUESTOS DE 2,4-PIRIMIDINDIAMINA Y SUS USOS. (PRODRUGS OF 2,4-PYRIMIDINEDIAMINE COMPOUNDS AND THEIR USES.) | ⤷ Sign Up |
| Norway | 2020010 | ⤷ 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 | CR 2020 00018 | Denmark | ⤷ Sign Up | 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 | C202030021 | Spain | ⤷ Sign Up | 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 | LUC00153 | Luxembourg | ⤷ Sign Up | 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 | CA 2020 00018 | Denmark | ⤷ Sign Up | 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 | 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 |
| >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.
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