Details for New Drug Application (NDA): 209299
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NDA 209299 describes TAVALISSE, which is a drug marketed by Rigel Pharms and is included in one NDA. It is available from one supplier. There are fourteen patents protecting this drug. Additional details are available on the TAVALISSE profile page.
The generic ingredient in TAVALISSE is fostamatinib disodium. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the fostamatinib disodium profile page.
The generic ingredient in TAVALISSE is fostamatinib disodium. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the fostamatinib disodium profile page.
Summary for 209299
| Tradename: | TAVALISSE |
| Applicant: | Rigel Pharms |
| Ingredient: | fostamatinib disodium |
| Patents: | 14 |
Suppliers and Packaging for NDA: 209299
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TAVALISSE | fostamatinib disodium | TABLET;ORAL | 209299 | NDA | Rigel Pharmaceuticals, Inc. | 71332-001 | 71332-001-01 | 60 TABLET in 1 BOTTLE (71332-001-01) |
| TAVALISSE | fostamatinib disodium | TABLET;ORAL | 209299 | NDA | Rigel Pharmaceuticals, Inc. | 71332-002 | 71332-002-01 | 60 TABLET in 1 BOTTLE (71332-002-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE | ||||
| Approval Date: | Apr 17, 2018 | TE: | AB | RLD: | Yes | ||||
| Patent: | 7,449,458 | Patent Expiration: | Sep 4, 2031 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patent: | 7,538,108 | Patent Expiration: | Mar 28, 2026 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patented Use: | TREATMENT OF THROMBOCYTOPENIA IN ADULT PATIENTS WITH CHRONIC IMMUNE THROMBOCYTOPENIA (ITP) WHO HAVE HAD AN INSUFFICIENT RESPONSE TO A PREVIOUS TREATMENT | ||||||||
| Patent: | 7,989,448 | Patent Expiration: | Jun 12, 2026 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patented Use: | TREATMENT OF THROMBOCYTOPENIA IN ADULT PATIENTS WITH CHRONIC IMMUNE THROMBOCYTOPENIA (ITP) WHO HAVE HAD AN INSUFFICIENT RESPONSE TO A PREVIOUS TREATMENT | ||||||||
Expired US Patents for NDA 209299
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Rigel Pharms | TAVALISSE | fostamatinib disodium | TABLET;ORAL | 209299-002 | Apr 17, 2018 | 8,211,889 | ⤷ Start Trial |
| Rigel Pharms | TAVALISSE | fostamatinib disodium | TABLET;ORAL | 209299-002 | Apr 17, 2018 | 7,538,108 | ⤷ Start Trial |
| Rigel Pharms | TAVALISSE | fostamatinib disodium | TABLET;ORAL | 209299-001 | Apr 17, 2018 | 9,737,554 | ⤷ Start Trial |
| Rigel Pharms | TAVALISSE | fostamatinib disodium | TABLET;ORAL | 209299-001 | Apr 17, 2018 | 8,445,485 | ⤷ Start Trial |
| Rigel Pharms | TAVALISSE | fostamatinib disodium | TABLET;ORAL | 209299-002 | Apr 17, 2018 | 7,989,448 | ⤷ Start Trial |
| Rigel Pharms | TAVALISSE | fostamatinib disodium | TABLET;ORAL | 209299-001 | Apr 17, 2018 | 7,538,108 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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