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Generated: November 21, 2018

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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.
Summary for 209299
Tradename:TAVALISSE
Applicant:Rigel Pharms Inc
Ingredient:fostamatinib disodium
Patents:14
Generic Entry Opportunity 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:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:Apr 17, 2018TE: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
Regulatory Exclusivity Expiration:Apr 17, 2023
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Try a Free TrialPatent Expiration:Sep 4, 2026Product Flag?Substance Flag?YDelist Request?

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