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 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

Summary for UKONIQ

International Patents:	68
US Patents:	8
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	9
Patent Applications:	26
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

International Patents for UKONIQ

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

Country	Patent Number	Title	Estimated Expiration
China	104470923	Selective PI3K delta inhibitors
Hong Kong	1209737	選擇性 δ抑制劑 (SELECTIVE PI3K DELTA INHIBITORS PI3K)
Slovenia	2870157

UKONIQ Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: UKONIQ

Introduction

UKONIQ (umbralisib), developed by TG Therapeutics, is a significant example of how market dynamics and financial trajectories can be heavily influenced by regulatory decisions, clinical trial outcomes, and market acceptance. Here, we delve into the various aspects that shaped the journey of UKONIQ from its approval to its eventual withdrawal from the market.

Approval and Initial Market Entry

UKONIQ received accelerated approval from the U.S. Food and Drug Administration (FDA) on February 5, 2021, for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) and follicular lymphoma (FL) who had received prior therapies[4][5].

Indications and Mechanism

UKONIQ is the first and only oral, dual inhibitor of phosphoinositide 3 kinase (PI3K) delta and casein kinase 1 (CK1) epsilon. This unique mechanism made it a promising treatment option for patients with limited therapeutic alternatives[4].

Commercial Launch and Revenue

Following its approval, UKONIQ was launched in the U.S. market, generating $2.3 million in net revenue for the first six months of 2021 and $6.5 million by the end of 2021, approximately ten months after launch[2][5].

Payor Coverage and Clinical Guidelines

The drug achieved broad U.S. payor coverage, with more than 95% of Medicare and commercial lives covered, and was included in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for MZL and FL. This extensive coverage was crucial for its market penetration[5].

Financial Performance

Revenue Growth

Despite the promising start, the total revenue generated by UKONIQ was relatively modest compared to the significant investment in research and development (R&D) and selling, general, and administrative (SG&A) expenses. For the year 2021, TG Therapeutics reported a net loss of $348.1 million, with R&D expenses totaling $222.6 million and SG&A expenses of $60.8 million[2][5].

Cash Position

As of December 31, 2021, TG Therapeutics had $350.3 million in cash, cash equivalents, and investment securities, which was expected to fund operations into 2023. However, the financial trajectory was heavily dependent on the continued success and commercialization of UKONIQ and other pipeline products[5].

Regulatory Challenges and Safety Concerns

Partial Clinical Hold

In January 2022, the FDA placed selected clinical trials investigating UKONIQ and another product, U2, on a partial clinical hold due to concerns about the benefit-risk profile. This regulatory action posed significant challenges to the company's plans for further commercialization and development[3].

Withdrawal from Market

The most critical blow came on June 1, 2022, when the FDA announced that UKONIQ was being withdrawn from the market due to safety concerns. Updated findings from the UNITY-CLL trial showed a possible increased risk of death in patients receiving UKONIQ, leading the FDA to determine that the risks outweighed the benefits[1].

Impact on Market Dynamics

Discontinuation of Prescriptions

The FDA recommended that healthcare professionals stop prescribing UKONIQ and switch patients to alternative treatments. This immediate action significantly impacted the drug's market presence and future revenue potential[1].

Expanded Access

In limited circumstances where patients were receiving benefit from UKONIQ, the manufacturer planned to make it available under expanded access programs. However, this did not mitigate the overall negative impact on the drug's commercial viability[1].

Financial Implications

Revenue Loss

The withdrawal of UKONIQ from the market resulted in an immediate halt in revenue generation from this product. This loss was particularly significant given the substantial investment in its development and commercialization[1].

Impact on Pipeline Products

The regulatory issues surrounding UKONIQ also cast a shadow on other pipeline products, such as U2 and ublituximab, which were pending FDA review. The company's ability to successfully commercialize these products was now under greater scrutiny[3].

Key Takeaways

• Accelerated Approval and Regulatory Risks: UKONIQ's accelerated approval highlighted the risks associated with this pathway, particularly the need for confirmatory trials to verify clinical benefit.
• Market Acceptance: Despite initial market entry and payor coverage, the drug's safety concerns led to its withdrawal, emphasizing the importance of long-term safety data.
• Financial Impact: The significant investment in UKONIQ was not recouped due to its early withdrawal, impacting the company's financial health and future product development.
• Pipeline Risks: Regulatory challenges with one product can have a ripple effect on other pipeline products, affecting overall business strategy and investor confidence.

FAQs

Q: What was the primary reason for the withdrawal of UKONIQ from the market?

A: UKONIQ was withdrawn due to safety concerns, specifically an increased risk of death observed in clinical trials.

Q: What were the approved indications for UKONIQ?

A: UKONIQ was approved for the treatment of adult patients with relapsed or refractory marginal zone lymphoma and follicular lymphoma who had received prior therapies.

Q: How much revenue did UKONIQ generate in its first year on the market?

A: UKONIQ generated $6.5 million in net revenue from its launch through the end of 2021.

Q: What was the impact of the FDA's partial clinical hold on TG Therapeutics' clinical trials?

A: The partial clinical hold due to concerns about the benefit-risk profile posed significant challenges to the company's plans for further commercialization and development of UKONIQ and other products.

Q: How did the withdrawal of UKONIQ affect TG Therapeutics' financial position?

A: The withdrawal resulted in an immediate halt in revenue generation from UKONIQ, impacting the company's financial health and future product development.

Sources

1. Hayes Inc. - Ukoniq Withdrawn from Market due to Safety Concerns
2. TG Therapeutics - TG Therapeutics Provides Business Update and Reports Second Quarter 2021 Financial Results
3. TG Therapeutics - TG THERAPEUTICS, INC.
4. Clinical Trials Arena - UKONIQ to Treat Marginal Zone Lymphoma and Follicular Lymphoma
5. TG Therapeutics - TG Therapeutics Provides Business Update and Reports Fourth Quarter and Full Year 2021 Financial Results