ONTAK Drug Profile

Summary for Tradename: ONTAK

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ONTAK

Recent Litigation for ONTAK

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC	2021-11-10
Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC	2021-05-12
Par Pharmaceutical, Inc. v. Eagle Pharmaceuticals, Inc.	2018-05-31

See all ONTAK litigation

PTAB Litigation

Petitioner	Date
	2017-11-17

See all ONTAK litigation

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. General brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for ONTAK Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for ONTAK Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for ONTAK Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Eisai, Incorporated	ONTAK	denileukin diftitox	Injection	103767	10,053,498	2034-11-21	Patent claims search
Eisai, Incorporated	ONTAK	denileukin diftitox	Injection	103767	10,072,246	2027-10-03	Patent claims search
Eisai, Incorporated	ONTAK	denileukin diftitox	Injection	103767	10,105,389	2036-04-01	Patent claims search
Eisai, Incorporated	ONTAK	denileukin diftitox	Injection	103767	10,111,968	2032-02-15	Patent claims search
Eisai, Incorporated	ONTAK	denileukin diftitox	Injection	103767	10,117,943	2039-02-26	Patent claims search

Market Dynamics and Financial Trajectory for the Biologic Drug: ONTAK

Introduction to Biologic Drugs

Biologic drugs, including ONTAK, are a class of medications derived from living organisms, such as cells, and are used to treat a variety of diseases, including cancers and autoimmune disorders. The biologics market is experiencing significant growth driven by several key factors.

Global Biologics Market Outlook

The global biologics market is projected to grow substantially, with the market size expected to reach USD 699.5 billion by 2032, growing at a CAGR of 7.8% during 2024-2032[1][4].

ONTAK: A Specific Biologic Drug

ONTAK, developed by Citius Oncology, is a biologic drug used for the treatment of cutaneous T-cell lymphoma (CTCL). Here’s a detailed look at its market dynamics and financial trajectory.

Historical Context

ONTAK was initially approved and marketed from 1999 to 2014. It has since been reformulated and is poised for a new commercial launch in the second half of 2024[3].

Market Need and Opportunity

The CTCL market, where ONTAK is positioned, is estimated to be between $300-$400 million. The existing therapies for CTCL are often non-curative, indicating a high unmet need and potential for rapid adoption of new treatments like ONTAK[3].

Competitive Landscape

The competitive environment in the biologics market is intense, with several players including large pharmaceutical companies and innovative biotech firms. The launch of competitive products, such as Poteligeo by Kyowa Kirin, highlights the ongoing demand for effective treatments in the CTCL space[3].

Technological Advancements

Technological advancements, including improved drug delivery systems and manufacturing technologies, are crucial for the development and cost-effectiveness of biologic drugs like ONTAK. These advancements enable the production of more targeted and efficient therapies[1][4].

Regulatory Approvals

Regulatory approvals play a critical role in the commercial success of biologic drugs. The anticipated commercial launch of ONTAK in 2024 is contingent on successful regulatory approvals, which are expected to drive market expansion[3].

Financial Trajectory

Revenue Potential

The anticipated commercial launch of ONTAK in the second half of 2024 is expected to generate significant revenue. Citius Oncology anticipates positive cash flow commencing within the first year of the product launch, indicating a strong financial trajectory[3].

Market Valuation

The company's valuation is expected to align with commercial-stage oncology peers, suggesting a potential increase in market value as the product gains traction. The merger negotiations and base exchange ratio set by TenX and Citius Pharma also reflect the anticipated value of Citius following the merger[3].

Growth Drivers

Several factors will drive the financial growth of ONTAK:

• Unmet Need: The high unmet need in CTCL treatment implies rapid adoption.
• Combination Therapies: Potential combinations with CAR-T and PD-1 therapies offer additional growth opportunities.
• Future Product In-Licensing: Multiple potential future product in-licensing opportunities further bolster the growth prospects[3].

Regional Market Impact

Asia-Pacific Region

The Asia-Pacific region, particularly countries like China and India, is expected to significantly impact the biologics market due to its large patient population and growing healthcare infrastructure. This region's growth is driven by high investment in biotechnology and R&D, favorable government policies, and a rising focus on personalized medicine[1].

Latin America

In Latin America, countries such as Brazil and Mexico are investing heavily in healthcare infrastructure, enhancing the distribution and availability of biologic therapies. Growing awareness of advanced treatment options and increasing incidence of chronic diseases drive market growth in this region[1].

Key Takeaways

• The global biologics market is expected to reach USD 699.5 billion by 2032.
• ONTAK, a biologic drug for CTCL, is set for a commercial launch in 2024 with significant revenue potential.
• Technological advancements and regulatory approvals are critical for market success.
• The Asia-Pacific and Latin American regions are key drivers of market growth due to their large patient populations and improving healthcare infrastructures.

FAQs

What is the projected market size for biologic drugs by 2032?

The global biologics market is expected to reach USD 699.5 billion by 2032, growing at a CAGR of 7.8% during 2024-2032[1].

What is the primary indication for the biologic drug ONTAK?

ONTAK is primarily used for the treatment of cutaneous T-cell lymphoma (CTCL)[3].

When is the anticipated commercial launch of ONTAK?

The anticipated commercial launch of ONTAK is in the second half of 2024[3].

What are the key drivers of the biologics market growth?

Key drivers include the rising prevalence of chronic diseases, technological advancements, growing adoption of biosimilars, improved healthcare infrastructure, and increasing awareness about biologic therapies[1].

How does the Asia-Pacific region impact the biologics market?

The Asia-Pacific region significantly impacts the biologics market due to its large patient population, growing healthcare infrastructure, high investment in biotechnology and R&D, and favorable government policies[1].

Cited Sources

1. Biologics Market Size to Reach USD 699.5 Billion by 2032, Impelled by Emergence of Advanced Drug Delivery Systems - Biospace
2. Ontrak Health Announces Expected 2024 Second Quarter Financial Results - Stocktitan
3. Citius Oncology, Inc. - Q4cdn
4. Biologic Therapeutic Drugs: Technologies and Global Markets - BCC Research