Details for New Drug Application (NDA): 209299
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NDA 209299 describes TAVALISSE, which is a drug marketed by Rigel Pharms Inc 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. 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. 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 Inc |
| Ingredient: | fostamatinib disodium |
| Patents: | 14 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 209299
Generic Entry Date for 209299*:
Constraining patent/regulatory exclusivity:
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.
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: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Apr 17, 2025 | ||||||||
| Regulatory Exclusivity Use: | FOR THE TREATMENT OF THROMBOCYTOPENIA IN ADULT PATIENTS WITH CHRONIC IMMUNE THROMBOCYTOPENIA (ITP) WHO HAVE HAD AN INSUFFICIENT RESPONSE TO A PREVIOUS TREATMENT | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Sep 4, 2031 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patent: | ⤷ Try a Trial | 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 | ||||||||
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