FOSTAMATINIB DISODIUM - Generic Drug Details
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What are the generic drug sources for fostamatinib disodium and what is the scope of patent protection?
Fostamatinib disodium
is the generic ingredient in one branded drug marketed by Rigel Pharms and is included in one NDA. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.Fostamatinib disodium has one hundred and eighteen patent family members in forty-five countries.
One supplier is listed for this compound.
Summary for FOSTAMATINIB DISODIUM
| International Patents: | 118 |
| US Patents: | 14 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 112 |
| Clinical Trials: | 19 |
| Patent Applications: | 518 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for FOSTAMATINIB DISODIUM |
| DailyMed Link: | FOSTAMATINIB DISODIUM at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for FOSTAMATINIB DISODIUM
*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 FOSTAMATINIB DISODIUM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Rigel Pharmaceuticals | Phase 3 |
| AstraZeneca | Phase 2 |
| AstraZeneca | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for FOSTAMATINIB DISODIUM
Paragraph IV (Patent) Challenges for FOSTAMATINIB DISODIUM
| 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 FOSTAMATINIB DISODIUM
| 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 | 209299-001 | Apr 17, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Rigel Pharms | TAVALISSE | fostamatinib disodium | TABLET;ORAL | 209299-002 | Apr 17, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Rigel Pharms | TAVALISSE | fostamatinib disodium | TABLET;ORAL | 209299-001 | Apr 17, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Rigel Pharms | TAVALISSE | fostamatinib disodium | TABLET;ORAL | 209299-001 | Apr 17, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Rigel Pharms | 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 FOSTAMATINIB DISODIUM
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Taiwan | 201311251 | New (trimethoxyphenylamino) pyrimidinyl formulations | ⤷ Sign Up |
| Denmark | 2217241 | ⤷ Sign Up | |
| Canada | 2673137 | PROMEDICAMENTS DE COMPOSES DE 2,4-PYRIMIDINEDIAMINE ET LEURSUTILISATIONS (PRODRUG SALTS OF 2, 4-PYRIMIDINEDIAMINE COMPOUNDS AND THEIR USES) | ⤷ Sign Up |
| Portugal | 2736487 | ⤷ Sign Up | |
| Poland | 2217241 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for FOSTAMATINIB DISODIUM
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1856135 | C20200009 00319 | Estonia | ⤷ Sign Up | PRODUCT NAME: FOSTAMATINIIB;REG NO/DATE: EU/1/19/1405 13.01.2020 |
| 1856135 | PA2020507,C1856135 | Lithuania | ⤷ Sign Up | PRODUCT NAME: FOSTAMATINIBO DINATRIO HEKSAHIDRATAS; REGISTRATION NO/DATE: EU/1/19/1405 20200109 |
| 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 |
| 1856135 | SPC/GB20/016 | United Kingdom | ⤷ 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; REGISTERED: UK EU/1/19/1405 (NI) 20200113; UK PLGB 12930/0022 20200113; UK PLGB 12930/0023 20200113 |
| 1856135 | 301039 | Netherlands | ⤷ Sign Up | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
