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
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 |
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
| 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
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 |
Make Better Decisions: Try a trial or see plans & pricing
Serving leading biopharmaceutical companies globally:
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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