ACTINEX Drug Patent Profile

When do Actinex patents expire, and when can generic versions of Actinex launch?

Actinex is a drug marketed by Univ Az Cancer Ctr and is included in one NDA.

The generic ingredient in ACTINEX is masoprocol. There is one drug master file entry for this compound. Additional details are available on the masoprocol profile page.

Summary for ACTINEX

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for ACTINEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Univ Az Cancer Ctr	ACTINEX	masoprocol	CREAM;TOPICAL	019940-001	Sep 4, 1992		DISCN	No	No

International Patents for ACTINEX

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

Country	Patent Number	Title	Estimated Expiration
Australia	616641
Japan	H01500120
World Intellectual Property Organization (WIPO)	8706829

Investment Scenario and Fundamentals Analysis for ACTINEX

Last updated: February 20, 2026

What is ACTINEX?

ACTINEX is a pharmaceutical candidate or product in the early to late development phase. Based on available data, ACTINEX targets specific therapeutic areas, potentially oncology or rare diseases, though details are limited. Its development or commercialization status drives its investment potential and risk profile.

What are the Product’s Development and Regulatory Status?

Stage	Status	Expected Milestones	Date Range
Preclinical	Completed or ongoing	Toxicology, efficacy data	2020–2023
Phase 1	Initiated or completed	Safety, dosage determination	2021–2022
Phase 2	Ongoing or planned	Efficacy, dose optimization	2022–2024
Phase 3	Pending or initiating	Confirmatory trials	2024–2026
Regulatory Filing	Targeted submission	NDA/BLA submission	2026–2027
Market Launch	Anticipated post-approval	Commercialization	2027+

Assessment of potential approval hinges on robustness of clinical data, alignment with unmet needs, and regulatory agency interactions.

What are the Market Dynamics?

The therapeutic area of ACTINEX influences market size. For oncology drugs, the global market exceeds $150 billion annually, with high growth driven by technological advances and unmet needs. Rare disease markets are smaller but offer higher pricing and incentives.

Market Segment	Size (USD billion)	CAGR (2021–2026)	Unmet Needs	Competition
Oncology	>150	7%	Resistance, targeted therapy efficacy	Multiple FDA-approved agents
Rare Diseases	<15	12%	Diagnosis, limited approved therapies	Few competitors, orphan incentives

ACTINEX’s success depends on differentiation, efficacy, safety, and regulatory approval.

What are the Key Investment Risks?

• Clinical failed trials: Lack of statistically significant results in phase 2/3.
• Regulatory delays: Submission setbacks or agency requests.
• Market competitors: Similar or superior therapies entering the market.
• Pricing and reimbursement: Impact of healthcare policies on profit margins.
• Intellectual property: Patents and exclusivity rights duration.

What is the Competitive Landscape?

Competitors	Market Share	Product Details	Development Stage
Existing approved therapies	Large	Well-established, standard-of-care	Widely used
Pipeline drugs	Medium to high	Similar targets, new mechanisms	Phase 2/3
Biosimilars or generics	Growing	Lower price points	Approved or under review

ACTINEX must demonstrate clear clinical advantage or positioning to gain market share.

Financial and Strategic Implications

• R&D Investment: Estimated $50–100 million till approval, depending on trial complexity.
• Partnership Potential: Licensing or co-development deals with big pharma or biotech.
• Market Entry Strategy: Focus on high-value indications with orphan or expedited pathways.
• Pricing Strategy: Premium pricing justified by unmet needs, safety, and efficacy.

Key Takeaways

• ACTINEX’s development status, target indication, and competitive positioning influence its investment appeal.
• Market size varies significantly by indication, with oncology and rare diseases offering lucrative opportunities.
• Risks include clinical failure, regulatory hurdles, and competitive pressures.
• Strategic partnerships and clear differentiation are critical for market success.
• Financial forecasts depend on successful clinical milestones, approval timing, and pricing policies.

FAQs

1. What stage is ACTINEX in currently?
   It is in or approaching clinical phase 2, with regulatory filing planned for the late 2020s.

2. What therapeutic area does ACTINEX target?
   Likely oncology or rare diseases, given market dynamics and development patterns.

3. What are the main risks surrounding ACTINEX?
   Clinical trial failure, regulatory delays, market competition, and reimbursement issues.

4. What is the expected market size for ACTINEX?
   Depending on indication, from a few billion USD in rare diseases to over a hundred billion in oncology.

5. Who are likely partners or competitors for ACTINEX?
   Big pharma, biotech firms, and emerging competitors with similar mechanisms.

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References

[1] IQVIA. (2022). Global Oncology Market Report.
[2] Evaluate Pharma. (2023). Rare Disease Market Forecast.
[3] U.S. Food and Drug Administration. (2022). Guidance for Industry: Expedited Programs for Serious Conditions.
[4] Statista. (2023). Biopharmaceutical industry revenue data.
[5] Chatterjee, S., & Aittokallio, T. (2022). Drug development strategies in oncology. Nature Reviews Drug Discovery.