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 eight 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.
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: | 8 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 200MG BASE | ||||
| Approval Date: | Feb 5, 2021 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Feb 5, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 10,072,013 | Patent Expiration: | Jul 2, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (FL) WHO HAVE RECEIVED AT LEAST THREE PRIOR LINES OF SYSTEMIC THERAPY | ||||||||
| Patent: | 10,072,013 | Patent Expiration: | Jul 2, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE PRIOR ANTI-CD20-BASED REGIMEN | ||||||||
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