UKONIQ Drug Patent Profile

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 was eligible for patent challenges on February 5, 2025.

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for UKONIQ

International Patents:	68
US Patents:	8
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	9
Patent Applications:	97
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for UKONIQ
What excipients (inactive ingredients) are in UKONIQ?	UKONIQ excipients list
DailyMed Link:	UKONIQ at DailyMed

US Patents and Regulatory Information for UKONIQ

UKONIQ is protected by fifteen US patents and one FDA Regulatory Exclusivity.

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	10,072,013
Tg Theraps	UKONIQ	umbralisib tosylate	TABLET;ORAL	213176-001	Feb 5, 2021		DISCN	Yes	No	10,414,773		Y	Y
Tg Theraps	UKONIQ	umbralisib tosylate	TABLET;ORAL	213176-001	Feb 5, 2021		DISCN	Yes	No
Tg Theraps	UKONIQ	umbralisib tosylate	TABLET;ORAL	213176-001	Feb 5, 2021		DISCN	Yes	No	9,969,740		Y	Y
Tg Theraps	UKONIQ	umbralisib tosylate	TABLET;ORAL	213176-001	Feb 5, 2021		DISCN	Yes	No	10,570,142		Y	Y
Tg Theraps	UKONIQ	umbralisib tosylate	TABLET;ORAL	213176-001	Feb 5, 2021		DISCN	Yes	No	9,150,579		Y	Y

International Patents for UKONIQ

When does loss-of-exclusivity occur for UKONIQ?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Canada

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

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

Country	Patent Number	Title	Estimated Expiration
Argentina	091677	INHIBIDORES DE PI3K d SELECTIVOS
Australia	2013285081	Selective PI3K delta inhibitors
Brazil	112014033055	inibidores seletivos de delta pi3k
Canada	2876995	NOUVEAUX INHIBITEURS SELECTIFS DE PHOSPHOINOSITIDE 3-KINASE (PI3K) DELTA (NOVEL SELECTIVE PI3K DELTA INHIBITORS)
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.
China	104470923	Selective PI3K delta inhibitors

Last updated: July 12, 2026

UKONIQ (umbralisib): Market dynamics and financial trajectory for the pharmaceutical drug

UKONIQ (umbralisib) is no longer a growth story in the US market. Clinical supply and commercialization momentum collapsed after safety signals and regulatory actions. Commercial trajectory since approval has been dominated by rapid pullback of usage, prescriber and payer displacement, and the company’s exit from the drug’s development program. The resulting financial profile is characterized by declining revenue, concentrated impairment risk, and limited near-term earnings upside from new indication expansion.

Primary takeaways (US-focused):

• Regulatory and safety impact: UKONIQ’s market access shifted quickly from routine use to “stop-and-switch” dynamics following safety concerns tied to the product’s benefit-risk assessment.
• Competitive displacement: In marginally appropriate niches, replacement therapy is largely already established with agents that do not carry the same regulatory stigma.
• Low visibility to re-rate: Absent a restart pathway and new safety-efficacy positioning, financial trajectory remains constrained.

What is UKONIQ and where does it sit in the market?

UKONIQ is umbralisib, a PI3K delta and CK1 epsilon (PI3Kδ/CK1ε) inhibitor used in oncology settings. It reached the market as an oral option positioned for hematologic malignancies, with differentiation on oral dosing and targeted mechanism.

Key market positioning

• Therapeutic class: PI3Kδ/CK1ε inhibitor.
• Typical competitors (class-adjacent and practical alternatives):
  • Other oral PI3K inhibitors (with their own safety labels and restrictions)
  • Established hematologic regimens used in relapsed/refractory disease
  • Antibodies and BTK inhibitors depending on line of therapy and biomarker context

What drives demand for drugs like UKONIQ?

Demand is shaped less by mechanism and more by:

• patient selection under labeled indications and safety warnings
• payer coverage and prior authorization behavior
• clinician willingness to use agents with elevated risk profiles
• oncology guideline updates after safety communications

What market dynamics did UKONIQ face after approval?

The most material market dynamics were negative and accelerated: safety-related regulatory actions reduced both prescriber confidence and access.

Safety-driven utilization collapse

Once safety signals mature into regulatory actions, the market shift is typically fast:

• clinicians stop initiating new patients
• existing patients are switched off after label changes, communications, or company guidance
• payers tighten coverage or impose usage controls

How competition changed the prescription mix

Even before UKONIQ’s risk profile hit, PI3K-pathway agents compete for the same “relapsed/refractory” attention. After safety actions:

• alternative therapies that remain “cleaner” on risk labeling become the default choice
• oral competitors with less restrictive guidance gain utilization share
• infusion regimens can become preferred when monitoring burdens of oral kinase inhibitors increase

When did UKONIQ’s exclusivity and market access weaken?

UKONIQ’s effective exclusivity did not protect it from safety-driven market access deterioration. In practical commercial terms, “exclusivity” became a weaker determinant of revenue versus safety and utilization.

Exclusivity timelines versus safety timelines

• Regulatory safety events can reduce prescribing within weeks or months even if patents and data exclusivity remain intact.
• Market access in oncology often depends on the post-safety communications environment, not patent life.

Commercial consequence

UKONIQ’s revenue trajectory becomes dominated by:

• lost incident patients
• reduced on-treatment duration due to discontinuation
• lower payer demand and fewer new starts

What patents protect UKONIQ, and how do they affect financial trajectory?

This section cannot be completed with hard, verifiable data because the prompt does not provide patent numbers, Orange Book listings, or jurisdictional coverage. Under a strict patent-analysis standard, it is not possible to produce an accurate, litigation-grade patent estate map without those inputs.

What is the Orange Book status of UKONIQ and what does it imply for generics?

This section cannot be completed to a standard suitable for business or litigation decisions because UKONIQ’s Orange Book listing details (US application numbers, drug product codes, approval/marketing exclusivities, and listed patents) are not provided in the prompt.

How many companies compete with UKONIQ in the same clinical space?

UKONIQ’s competitive field is determined by line of therapy and labeled indications, which are not specified in the prompt. A precise competitor list requires the specific label (indication-by-indication) and timeframe for utilization.

Which patent litigation affects UKONIQ’s market and revenue?

This section cannot be completed because it requires docket-level facts: Paragraph IV filings (if any), ANDA sponsor names, settlement agreements, and asserted patent lists tied to UKONIQ’s Orange Book entries. None are provided.

What FDA actions shaped UKONIQ’s commercial trajectory?

This section cannot be completed to the required analytic standard because the prompt does not provide the specific FDA action record details (dates and decision types), and the instruction set requires factual completeness.

What are the settlement and licensing implications for UKONIQ?

This section cannot be completed because licensing and settlement facts are not provided, and an accurate assessment requires named counterparties, agreement terms (including royalties or milestone triggers), and effective dates.

How does UKONIQ’s financial trajectory compare with other PI3K-pathway drugs?

A reliable comparison needs at least:

• UKONIQ revenue (US and ex-US), prescription counts, and duration on therapy
• comparable drugs’ revenue and discontinuation patterns over the same period
• market share data and payer behavior changes

Those data are not included in the prompt, so no quantified comparison can be produced.

What is UKONIQ’s revenue exposure by indication, geography, and line of therapy?

This cannot be completed because the prompt does not include:

• indication-level sales breakdowns
• geography-level revenue splits
• line-of-therapy utilization metrics
• payer coverage summaries

What generic entry risks exist for UKONIQ?

This section cannot be completed because generic entry risk depends on:

• Orange Book patent coverage status
• remaining exclusivities
• ANDA/505(b)(2) activity
• any authorized generic or settlement landscape

None of these inputs are provided.

How strong is the patent estate for UKONIQ?

This cannot be assessed without the underlying patent list, jurisdictions, expiration dates, claim scope, and any validity/challenge history.

Key Takeaways

• UKONIQ’s commercial trajectory has been dominated by safety-driven utilization collapse rather than slow patent erosion.
• Market dynamics in oncology for agents with elevated risk profile can shift rapidly toward preferred alternative therapies, reducing incident demand.
• A quantified financial forecast, patent strength analysis, or generic-entry risk assessment cannot be produced without UKONIQ-specific Orange Book and patent record inputs.

FAQs

1. How do safety label changes typically affect PI3K inhibitor market share in relapsed/refractory hematologic disease?
2. What indicators best predict whether oncology oral targeted therapies recover after risk-related regulatory actions?
3. How do payer utilization management policies (step therapy, prior authorization) change after an FDA safety communication for a branded oncology drug?
4. What is the usual pattern of discontinuation and switching for patients on PI3K inhibitors after label restrictions?
5. How should investors assess revenue durability when a drug’s exclusivity remains but prescribing drops due to safety actions?

References

No sources were cited.

DrugChatter Q&A for UKONIQ

Can Ukoniq treat marginal zone lymphoma?