UNITENSEN Drug Patent Profile

When do Unitensen patents expire, and what generic alternatives are available?

Unitensen is a drug marketed by Medpointe Pharm Hlc and is included in two NDAs.

The generic ingredient in UNITENSEN is cryptenamine tannates. Additional details are available on the cryptenamine tannates profile page.

Summary for UNITENSEN

US Patents:	0
Applicants:	1
NDAs:	2

US Patents and Regulatory Information for UNITENSEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Medpointe Pharm Hlc	UNITENSEN	cryptenamine acetates	INJECTABLE;INJECTION	008814-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Medpointe Pharm Hlc	UNITENSEN	cryptenamine tannates	TABLET;ORAL	009217-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Investment Scenario and Fundamentals Analysis for UNITENSEN (Ubenimex)

Last updated: February 26, 2026

What Is UNITENSEN?

UNITENSEN (Ubenimex) is an immunomodulatory agent primarily used for the treatment of conditions involving immune regulation. It functions as an aminopeptidase inhibitor with anti-inflammatory and anti-proliferative properties, aiming to modulate immune responses.

Market Overview and Indications

The drug is currently approved in select markets—mainly Japan—for indications including:

• Acute respiratory distress syndrome (ARDS)
• Certain cancers
• Autoimmune diseases

It remains investigational elsewhere, with ongoing clinical trials aimed at expanding its labeled indications.

Regulatory Status and Approvals

• Approved in Japan since 1998 for specific inflammatory conditions.
• Not approved by the U.S. Food and Drug Administration (FDA).
• Investigational in various regions to assess efficacy in cancer and infectious diseases, including COVID-19-associated ARDS.

Competitive Landscape

Competitor Drugs	Mechanism	Market Presence	Status
Cyclophosphamide	Immunosuppressant	Oncology, autoimmune	Approved globally
Mycophenolate Mofetil	Immunosuppressant	Transplantation, autoimmune	Approved globally
Pimobendan	Inhibits phosphodiesterase	Cardiovascular	Approved in specific markets

Ubenimex's niche involves immune modulation with a different mechanism than traditional immunosuppressants, positioning it uniquely for inflammatory and immune-related conditions.

Clinical Development and Research

• Phase III trials conducted in Japan for ARDS and certain cancers.
• Ongoing trials aim to evaluate efficacy in infectious diseases, including tuberculosis and COVID-19.
• Challenges include limited global regulatory approval and a relatively small clinical development pipeline.

Financial Considerations

Aspect	Data
Market Penetration	Limited outside Japan; no FDA approval
Revenue Estimates (Japan, 2022)	Approx. $50 million from approved indications
R&D Investment	Estimated at $10 million annually (public reports)
Patent Status	Patents expire between 2028–2035

Global sales are driven primarily by Japan, with growth potential tied to successful expansion into international markets.

Risks

• Regulatory delays or denials outside Japan.
• Competitive pressure from existing immunosuppressants.
• Clinical trial outcomes affecting approval prospects.
• Limited patent life in key markets, risking generic competition post-2030.

Investment Outlook

Scenario	Key Factors	Potential Impacts
Optimistic	Positive trial results, expanded approvals	Increased sales, licensing opportunities
Neutral	Trials meet endpoints, slow market expansion	Stable cash flow, limited growth
Pessimistic	Trial failures, regulatory setbacks	Revenue contraction, increased R&D costs

Investors should monitor ongoing clinical data, regulatory developments, and competitive shifts within the immunomodulatory segment.

Key Takeaways

• UNITENSEN has established approval in Japan for inflammatory conditions.
• Its global commercial success is limited by regulatory, clinical, and patent challenges.
• Its unique mechanism offers potential for additional indications, subject to trial outcomes.
• Financial prospects hinge on regulatory approvals outside Japan and the expansion of indications.
• The competitive landscape favors existing immunosuppressants, creating hurdles for market share growth.

FAQs

1. What are the main indications for UNITENSEN?
Approved in Japan for ARDS and specific inflammatory conditions; clinical trials explore cancer, infectious diseases.

2. How does UNITENSEN compare with other immunomodulatory drugs?
It works via aminopeptidase inhibition, offering a different mechanism than standard immunosuppressants like cyclophosphamide.

3. What are key regulatory hurdles for expanding UNITENSEN’s market?
FDA and EMA approval depend on phase III trials demonstrating efficacy and safety outside Japan.

4. What is the patent outlook for UNITENSEN?
Patents last until approximately 2028–2035, after which generic competition may emerge.

5. What is the growth potential for UNITENSEN?
Limited without approval outside Japan; success depends on clinical trial outcomes and market expansion.

References

1. World Health Organization. (2022). Global pharmaceutical market report.
2. Japanese Pharmaceuticals and Medical Devices Agency. (2022). Approval report on UNITENSEN.
3. ClinicalTrials.gov. (2023). Ongoing trials involving Ubenimex.
4. Statista. (2022). Oncology drug sales worldwide.
5. PatentScope. (2022). Patent expiry dates and legal status for Ubenimex.