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Last Updated: October 1, 2022

UKONIQ Drug Patent Profile


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Which patents cover Ukoniq, and when can generic versions of Ukoniq launch?

Ukoniq is a drug marketed by Tg Theraps and is included in one NDA. There are eight patents protecting this drug.

This drug has sixty-eight patent family members in thirty-one countries.

The generic ingredient in UKONIQ is umbralisib tosylate. Additional details are available on the umbralisib tosylate profile page.

DrugPatentWatch® Generic Entry Outlook for Ukoniq

Ukoniq will be eligible for patent challenges on February 5, 2025. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 26, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for UKONIQ
International Patents:68
US Patents:8
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 41
Patent Applications: 157
What excipients (inactive ingredients) are in UKONIQ?UKONIQ excipients list
DailyMed Link:UKONIQ at DailyMed
Drug patent expirations by year for UKONIQ
DrugPatentWatch® Estimated Generic Entry Opportunity Date for UKONIQ
Generic Entry Date for UKONIQ*:
Constraining patent/regulatory exclusivity:
NDA:
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.

US Patents and Regulatory Information for UKONIQ

UKONIQ is protected by fifteen US patents and three FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of UKONIQ is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting UKONIQ

Selective PI3K delta inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE PRIOR ANTI-CD20-BASED REGIMEN

Selective PI3K delta inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (FL) WHO HAVE RECEIVED AT LEAST THREE PRIOR LINES OF SYSTEMIC THERAPY

Forms of a PI3K delta selective inhibitor for use in pharmaceutical formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE PRIOR ANTI-CD20-BASED REGIMEN

Forms of a PI3K delta selective inhibitor for use in pharmaceutical formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (FL) WHO HAVE RECEIVED AT LEAST THREE PRIOR LINES OF SYSTEMIC THERAPY


Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (FL) WHO HAVE RECEIVED AT LEAST THREE PRIOR LINES OF SYSTEMIC THERAPY


Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE PRIOR ANTI-CD20-BASED REGIMEN

Forms of a PI3K delta selective inhibitor for use in pharmaceutical formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE PRIOR ANTI-CD20-BASED REGIMEN

Forms of a PI3K delta selective inhibitor for use in pharmaceutical formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (FL) WHO HAVE RECEIVED AT LEAST THREE PRIOR LINES OF SYSTEMIC THERAPY

Selective PI3K delta inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE PRIOR ANTI-CD20-BASED REGIMEN

Selective PI3K delta inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (FL) WHO HAVE RECEIVED AT LEAST THREE PRIOR LINES OF SYSTEMIC THERAPY

Selective PI3K delta inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Selective PI3K delta inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE PRIOR ANTI-CD20-BASED REGIMEN

Selective PI3K delta inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (FL) WHO HAVE RECEIVED AT LEAST THREE PRIOR LINES OF SYSTEMIC THERAPY

Forms of a PI3K delta selective inhibitor for use in pharmaceutical formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (FL) WHO HAVE RECEIVED AT LEAST THREE PRIOR LINES OF SYSTEMIC THERAPY

Forms of a PI3K delta selective inhibitor for use in pharmaceutical formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE PRIOR ANTI-CD20-BASED REGIMEN

FDA Regulatory Exclusivity protecting UKONIQ

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

FOR TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE PRIOR ANTI-CD20-BASED REGIMEN
Exclusivity Expiration: See Plans and Pricing

FOR TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (FL) WHO HAVE RECEIVED AT LEAST THREE PRIOR LINES OF SYSTEMIC THERAPY
Exclusivity Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Tg Theraps UKONIQ umbralisib tosylate TABLET;ORAL 213176-001 Feb 5, 2021 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Tg Theraps UKONIQ umbralisib tosylate TABLET;ORAL 213176-001 Feb 5, 2021 DISCN Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Tg Theraps UKONIQ umbralisib tosylate TABLET;ORAL 213176-001 Feb 5, 2021 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Tg Theraps UKONIQ umbralisib tosylate TABLET;ORAL 213176-001 Feb 5, 2021 DISCN Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Tg Theraps UKONIQ umbralisib tosylate TABLET;ORAL 213176-001 Feb 5, 2021 DISCN Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Tg Theraps UKONIQ umbralisib tosylate TABLET;ORAL 213176-001 Feb 5, 2021 DISCN Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for UKONIQ

See the table below for patents covering UKONIQ around the world.

Country Patent Number Title Estimated Expiration
Australia 2013285081 Selective PI3K delta inhibitors See Plans and Pricing
Japan 6181173 See Plans and Pricing
Chile 2014003511 Compuesto 2-(1-(4-amino-3-(3-fluoro-4-isopropoxifenil)-1h-pirazolo[3,4-d]pirimidin-1-il)etil)-6-fluoro-3-(3-fluorofenil)-4h-cromen-4-ona y sus sales, inhibidor selectivo de cinasas delta p13k; composicion farmaceutica; uso para tratar una enfermedad o trastorno tal como cancer, trastorno oseo, enfermedad inflamatoria, inmunitaria, metabolica, entre otras. See Plans and Pricing
Colombia 7170166 Inhibidores de pi3k delta selectivos See Plans and Pricing
Serbia 56494 SELEKTIVNI INHIBITORI PI3K DELTA (SELECTIVE PI3K DELTA INHIBITORS) See Plans and Pricing
Japan 2017516785 医薬製剤用PI3Kデルタ選択的抑制剤の改良形態 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.