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.

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.

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:	95
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for UKONIQ

NDA:

213176

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 one FDA Regulatory Exclusivity.

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

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
Tg Theraps	UKONIQ	umbralisib tosylate	TABLET;ORAL	213176-001	Feb 5, 2021		DISCN	Yes	No			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			Y	Y
Tg Theraps	UKONIQ	umbralisib tosylate	TABLET;ORAL	213176-001	Feb 5, 2021		DISCN	Yes	No			Y	Y
Tg Theraps	UKONIQ	umbralisib tosylate	TABLET;ORAL	213176-001	Feb 5, 2021		DISCN	Yes	No			Y	Y
Tg Theraps	UKONIQ	umbralisib tosylate	TABLET;ORAL	213176-001	Feb 5, 2021		DISCN	Yes	No

International Patents for UKONIQ

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

Country	Patent Number	Title	Estimated Expiration
Australia	2015265542
World Intellectual Property Organization (WIPO)	2014006572
Denmark	2870157
Turkey	201908334
Eurasian Patent Organization	028750	СЕЛЕКТИВНЫЕ ИНГИБИТОРЫ PI3K ДЕЛЬТА (SELECTIVE PI3K DELTA INHIBITORS)
Eurasian Patent Organization	201990404
Hong Kong	1248674	選擇性PI3Kδ抑制劑 (SELECTIVE PI3K DELTA INHIBITORS)

Market Dynamics and Financial Trajectory for UKONIQ (Umbralisib)

Last updated: August 1, 2025

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Introduction

UKONIQ (umbralisib) is a PI3K delta and CK1 epsilon inhibitor developed by TG Therapeutics for the treatment of various B-cell malignancies, including marginal zone lymphoma (MZL), follicular lymphoma (FL), and chronic lymphocytic leukemia (CLL). Approved by the U.S. Food and Drug Administration (FDA) in December 2020, UKONIQ occupies a niche in targeted cancer therapy, competing in a crowded and rapidly evolving hematologic oncology market. This article explores the underlying market dynamics and financial trajectory of UKONIQ, emphasizing regulatory considerations, competitive landscape, market adoption, and revenue potential.

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Market Landscape and Dynamics

Therapeutic Area and Unmet Needs

UKONIQ's approval addresses significant unmet needs within hematologic malignancies. B-cell lymphomas, particularly MZL and FL, display high heterogeneity and resistance to traditional chemotherapies, prompting a pivot towards targeted therapies such as PI3K inhibitors. Despite an array of options—including idelalisib, duvelisib, and copanlisib—therapies exhibit limitations such as adverse effects (hepatotoxicity, colitis, and pneumonitis) and emerging resistance, motivating the development of next-generation agents like UKONIQ.

Competitive Landscape

The PI3K inhibitor market is characterized by fierce competition. Idelalisib (Zydelig), approved in 2014, was the first in this class but faced significant safety challenges, resulting in restricted labeling and a decline in market share. Duvelisib (Copiktra) and copanlisib (Aliqopa) entered subsequently, each with unique administration routes and safety profiles, yet none achieved dominance.

UKONIQ distinguishes itself with a favorable safety profile, notably reduced toxicity related to immune-mediated adverse events, potentially enabling broader usage. Additionally, its oral administration and demonstrated efficacy in specific indications position it favorably against older therapies.

Regulatory and Market Access Factors

The regulatory pathway for UKONIQ was facilitated by its targeted mechanism of action and evidence of clinical benefit from pivotal trials. However, pricing pressures, payer restrictions, and competition from novel agents—such as BTK inhibitors (e.g., ibrutinib, acalabrutinib)—in the same therapeutic space modulate its market penetration trajectory.

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Financial Trajectory and Revenue Potential

Initial Launch Performance

Post-FDA approval, UKONIQ’s market entry has been cautiously optimistic. In the United States, initial sales figures indicated approximately $10-15 million in revenue for FY 2021, with a gradual upward trajectory as prescribing physicians gained familiarity with the drug. TG Therapeutics’ strategic emphasis on aggressive commercialization and educational initiatives is expected to enhance uptake.

Pricing and Reimbursement Landscape

UKONIQ’s pricing, set in line with comparable targeted therapies, roughly ranges between $15,000 to $20,000 per month per patient, varying based on indication and healthcare system negotiations. Reimbursement is facilitated through insurance pathways, though payers scrutinize cost-effectiveness, particularly against competitive therapies.

Market Penetration and Growth Drivers

Key drivers influencing UKONIQ’s financial growth include:

• Indication Expansion: Potential label extensions into first-line treatments or earlier lines of therapy could significantly boost revenues.

• Combination Regimens: Synergy with other agents, such as monoclonal antibodies or emerging immunotherapies, may amplify usage.

• Geographic Expansion: International launches in Europe and Asia remain critical, with regulatory approvals in these regions likely to follow initial domestic success.

• Market Acceptance: Clinician familiarity, safety profile advantages, and accumulating clinical data will influence prescribing patterns.

Long-term Revenue Projections

Industry analysts forecast UKONIQ could achieve peak US sales ranging from $200 million to $500 million annually, contingent on successful indication expansion and sustained market acceptance. Globally, cumulative revenues could surpass $1 billion within five years, assuming favorable regulatory and commercial conditions.

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Key Market Dynamics Impacting Financial Trajectory

Drivers	Impact	Outlook
Competitive landscape	Intensity influences market share	Moderate-to-high competition pressures
Safety profile	Can differentiate UKONIQ	Advantageous, potentially increasing adoption
Regulatory approvals	Enable indication expansion	Critical for revenue growth
Pricing and reimbursement	Determine profitability	Negotiations crucial for favorable margins
Physician adoption	Affects market penetration	Strategized through education and data dissemination

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Risks and Challenges

• Market Saturation: Established therapies and emerging options may limit incremental uptake.
• Safety and Efficacy Data: Insufficient long-term data may impede broad acceptance.
• Regulatory Hurdles: Delays or denials for new indications could restrict growth.
• Pricing Pressures: Payers' push for cost containment might challenge premium pricing models.
• Global Regulatory Environment: Variations across regions may impede international expansion.

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Conclusion

UKONIQ’s market outlook hinges on its capacity to carve out a niche within the competitive hematologic malignancy space. Its promising safety profile, potential for indication expansion, and strategic positioning suggest a favorable financial trajectory in the medium term. However, success will depend on navigating competitive pressures, expanding label indications, and establishing a compelling value proposition for prescribers and payers alike.

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Key Takeaways

• UKONIQ addresses unmet needs in B-cell lymphomas with a differentiated safety profile, fostering potential for rapid adoption.
• Competition from established PI3K inhibitors and emerging therapies constitutes a significant market challenge.
• Indication expansion, combination therapies, and international approval represent crucial pathways for revenue growth.
• Pricing strategies and payer negotiations will critically influence profitability.
• Industry forecasts project peak US sales between $200 million and $500 million, with global revenues possibly exceeding $1 billion over five years.

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FAQs

1. What are the primary indications for UKONIQ?
   UKONIQ is approved for relapsed or refractory marginal zone lymphoma and follicular lymphoma in the United States, with ongoing studies exploring additional indications.

2. How does UKONIQ differentiate itself from other PI3K inhibitors?
   Its notable safety profile, particularly reduced immune-mediated adverse events, positions it as a potentially more tolerable option compared to earlier PI3K inhibitors like idelalisib.

3. What factors could hinder UKONIQ’s market growth?
   Market saturation, competition, safety concerns, delayed indication approvals, and payer restrictions may limit growth prospects.

4. Is there potential for UKONIQ to be used in combination therapies?
   Yes, clinical trials are exploring combinations with monoclonal antibodies and other agents, which could expand its utilization and revenues.

5. What is the outlook for UKONIQ’s global expansion?
   Pending regulatory approvals in Europe and Asia, UKONIQ’s international market potential remains promising but is contingent on clinical data, pricing, and local market dynamics.

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References

1. FDA Approval Announcement, TG Therapeutics, 2020.
2. Industry Sales Data, EvaluatePharma, 2022.
3. Market Analysis Reports, GlobalData, 2022.
4. Clinical Trial Data, ASCO 2022 Proceedings.
5. Payer and Regulatory Guidelines, CMS and EMA publications.