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Fostamatinib disodium - Generic Drug Details
» See Plans and Pricing
What are the generic drug sources for fostamatinib disodium and what is the scope of freedom to operate?
Fostamatinib disodium
is the generic ingredient in one branded drug marketed by Rigel Pharms Inc 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 ten patent family members in forty-one countries.
Summary for fostamatinib disodium
| International Patents: | 110 |
| US Patents: | 14 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Bulk Api Vendors: | 53 |
| Clinical Trials: | 18 |
| Patent Applications: | 8 |
| DailyMed Link: | fostamatinib disodium at DailyMed |
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 |
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 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 | 209299-002 | 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 | 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 | |||
| >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 | Estimated Expiration |
|---|---|---|
| New Zealand | 555947 | Start Trial |
| Brazil | 112014001999 | Start Trial |
| Japan | 2008527048 | Start Trial |
| Austria | 540041 | Start Trial |
| Ukraine | 91210 | Start Trial |
| South Korea | 20100088622 | Start Trial |
| Spain | 2672519 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for fostamatinib disodium
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 | PA2020507 | Lithuania | Start Trial | PRODUCT NAME: FOSTAMATINIBO DINATRIO HEKSAHIDRATAS; REGISTRATION NO/DATE: EU/1/19/1405 20200109 |
| 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 | 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 |
| 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 | 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 | 2020C/511 | Belgium | Start 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 |
