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TAVALISSE Drug 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 eleven patent family members in forty-two countries.
The generic ingredient in TAVALISSE is fostamatinib disodium. Additional details are available on the fostamatinib disodium profile page.
US ANDA Litigation and Generic Entry Outlook for Tavalisse
Tavalisse will be eligible for patent challenges on April 17, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
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: | 111 |
US Patents: | 14 |
Applicants: | 1 |
NDAs: | 1 |
Bulk Api Vendors: | 71 |
Clinical Trials: | 1 |
Patent Applications: | 1,148 |
Drug Prices: | Drug price information for TAVALISSE |
DailyMed Link: | TAVALISSE at DailyMed |


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 |
---|---|
Washington University School of Medicine | Phase 2 |
Rigel Pharmaceuticals | Phase 2 |
US Patents and Regulatory Information for TAVALISSE
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 | Start Trial | Start Trial | Start Trial | ||||
Rigel Pharms Inc | TAVALISSE | fostamatinib disodium | TABLET;ORAL | 209299-002 | Apr 17, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
Rigel Pharms Inc | TAVALISSE | fostamatinib disodium | TABLET;ORAL | 209299-002 | Apr 17, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
Rigel Pharms Inc | TAVALISSE | fostamatinib disodium | TABLET;ORAL | 209299-001 | Apr 17, 2018 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
Rigel Pharms Inc | TAVALISSE | fostamatinib disodium | TABLET;ORAL | 209299-002 | Apr 17, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
Rigel Pharms Inc | TAVALISSE | fostamatinib disodium | TABLET;ORAL | 209299-002 | Apr 17, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start 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
Country | Patent Number | Estimated Expiration |
---|---|---|
World Intellectual Property Organization (WIPO) | 2006078846 | Start Trial |
Turkey | 201807879 | Start Trial |
Nicaragua | 201000078 | Start Trial |
Japan | 2010510322 | Start Trial |
Hungary | E042611 | Start Trial |
Brazil | PI0606318 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for TAVALISSE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1856135 | 122020000021 | Germany | Start Trial | PRODUCT NAME: FOSTAMATINIB; PHARMAZEUTISCH ANNEHMBARES SALZ VON FOSTAMATINIB; HYDRAT, SOVAT ODER N-OXID VON FOSTAMATINIB ODER DES PHARMAZEUTISCH ANNEHMBAREN SALZES VON FOSTAMATINIB; DINATRIUM-FOSTAMATINIB; DINATRIUM-FOSTAMATINIB-HYDRAT; REGISTRATION NO/DATE: EU/1/19/1405 20200109 |
1856135 | 301039 | Netherlands | Start Trial | PRODUCT NAME: FOSTAMATINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN FOSTAMATINIB, OF EEN HYDRAAT, SOLVAAT OF N-OXIDE VAN FOSTAMATINIB OF HET FARMACEUTISCH AANVAARDBARE ZOUT VAN FOSTAMATINIB, IN HET BIJZONDER DINATRIUMFOSTAMATINIB EVENTUEEL IN DE VORM VAN EEN HYDRAAT; REGISTRATION NO/DATE: EU/1/19/1405 20200113 |
1856135 | 2020/017 | Ireland | Start Trial | 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 | 132020000000046 | Italy | Start Trial | PRODUCT NAME: FOSTAMATINIB O SUO SALE FARMACEUTICAMENTE ACCETTABILE O IDRATO, SOLVATO O N-OSSIDO DI FOSTAMATINIB O DI SUO SALE FARMACEUTICAMENTE ACCETTABILE, IN PARTICOLARE FOSTAMATINIB DISODICO, FACOLTATIVAMENTE NELLA SUA FORMA IDRATA(TAVLESSE - FOSTAMATINIB); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1405, 20200113 |
1856135 | CA 2020 00018 | Denmark | Start Trial | 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 | LUC00153 | Luxembourg | Start 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |