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Fostamatinib disodium - Generic Drug Details
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 thirteen patent family members in forty-three countries.
Summary for fostamatinib disodium
| International Patents: | 113 |
| US Patents: | 14 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 55 |
| Clinical Trials: | 19 |
| Patent Applications: | 9 |
| 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 | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| Rigel Pharms Inc | TAVALISSE | fostamatinib disodium | TABLET;ORAL | 209299-002 | Apr 17, 2018 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | Y | ⤷ Try it Free | |||
| Rigel Pharms Inc | TAVALISSE | fostamatinib disodium | TABLET;ORAL | 209299-001 | Apr 17, 2018 | RX | Yes | No | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| Rigel Pharms Inc | TAVALISSE | fostamatinib disodium | TABLET;ORAL | 209299-002 | Apr 17, 2018 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | Y | ⤷ Try it Free | |||
| >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 |
|---|---|---|
| Hong Kong | 1198741 | ⤷ Try it Free |
| Cuba | 20100089 | ⤷ Try it Free |
| Israel | 183890 | ⤷ Try it Free |
| European Patent Office | 2217241 | ⤷ Try it Free |
| >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 | ⤷ Try it Free | 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 | ⤷ Try it Free | PRODUCT NAME: FOSTAMATINIBO DINATRIO HEKSAHIDRATAS; REGISTRATION NO/DATE: EU/1/19/1405 20200109 |
| 1856135 | 132020000000046 | Italy | ⤷ Try it Free | 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 | 2090014-8 | Sweden | ⤷ Try it Free | PRODUCT NAME: FOSTAMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, OR A HYDRATE OR SOLVATE OF FOSTAMATINIB OR THE PH ARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, ESPECIALLY FOSTAMATINIB DISODIUM, OPTIONALLY IN FORM OF A HYDRATE; REG. NO/DATE: EU/1/19/1405 20200113 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
