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Last Updated: July 27, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 213176


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NDA 213176 describes UKONIQ, which is a drug marketed by Tg Theraps and is included in one NDA. There are seven patents protecting this drug. Additional details are available on the UKONIQ profile page.

The generic ingredient in UKONIQ is umbralisib tosylate. Additional details are available on the umbralisib tosylate profile page.
Summary for 213176
Tradename:UKONIQ
Applicant:Tg Theraps
Ingredient:umbralisib tosylate
Patents:7
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 213176
Generic Entry Date for 213176*:
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.

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 200MG BASE
Approval Date:Feb 5, 2021TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 5, 2028
Regulatory Exclusivity Use:
Regulatory Exclusivity Expiration:Feb 5, 2026
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:⤷  Try it FreePatent Expiration:Jul 2, 2033Product Flag?Substance Flag?Delist Request?
Patented Use:RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (FL) WHO HAVE RECEIVED AT LEAST THREE PRIOR LINES OF SYSTEMIC THERAPY

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