TRISENOX Drug Patent Profile

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

Trisenox is a drug marketed by Cephalon and is included in one NDA.

The generic ingredient in TRISENOX is arsenic trioxide. There are five drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the arsenic trioxide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Trisenox

A generic version of TRISENOX was approved as arsenic trioxide by FRESENIUS KABI USA on August 31^st, 2018.

Summary for TRISENOX

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	17
Clinical Trials:	38
Patent Applications:	89
Drug Prices:	Drug price information for TRISENOX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TRISENOX
What excipients (inactive ingredients) are in TRISENOX?	TRISENOX excipients list
DailyMed Link:	TRISENOX at DailyMed

See drug prices for TRISENOX

Recent Clinical Trials for TRISENOX

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Hospital Universitario Dr. Jose E. Gonzalez	Phase 1/Phase 2
Jean Yuh Tang	Early Phase 1
National Cancer Institute (NCI)	Early Phase 1

See all TRISENOX clinical trials

Paragraph IV (Patent) Challenges for TRISENOX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TRISENOX	Injection	arsenic trioxide	1 mg/mL	021248	1	2015-08-11

US Patents and Regulatory Information for TRISENOX

TRISENOX is protected by zero US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cephalon	TRISENOX	arsenic trioxide	INJECTABLE;INJECTION	021248-001	Sep 25, 2000		DISCN	Yes	No
Cephalon	TRISENOX	arsenic trioxide	INJECTABLE;INJECTION	021248-002	Oct 13, 2017	AP	RX	Yes	Yes

Expired US Patents for TRISENOX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cephalon	TRISENOX	arsenic trioxide	INJECTABLE;INJECTION	021248-002	Oct 13, 2017
Cephalon	TRISENOX	arsenic trioxide	INJECTABLE;INJECTION	021248-001	Sep 25, 2000
Cephalon	TRISENOX	arsenic trioxide	INJECTABLE;INJECTION	021248-002	Oct 13, 2017

EU/EMA Drug Approvals for TRISENOX

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Mylan Ireland Limited	Arsenic trioxide Mylan	arsenic trioxide	EMEA/H/C/005235Arsenic trioxide Mylan is indicated for induction of remission, and consolidation in adult patients with:- Newly diagnosed low to intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count, ≤ 10 x 103/μl) in combination with all trans retinoic acid (ATRA)- Relapsed/refractory acute promyelocytic leukaemia (APL) (Previous treatment should have included a retinoid and chemotherapy)characterised by the presence of the t(15;17) translocation and/or the presence of the promyelocytic leukaemia/retinoic acid receptor alpha (PML/RAR alpha) gene.The response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not beenexamined.	Authorised	yes	no	no	2020-04-01
Accord Healthcare S.L.U.	Arsenic trioxide Accord	arsenic trioxide	EMEA/H/C/005175Arsenic trioxide is indicated for induction of remission, and consolidation in adult patients with:Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count, ≤ 10 x 103/μl) in combination with all-trans-retinoic acid (ATRA)Relapsed/refractory acute promyelocytic leukaemia (APL)(Previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the promyelocytic leukaemia/retinoic-acid-receptor-alpha (PML/RAR-alpha) gene.The response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not been examined.	Authorised	yes	no	no	2019-11-14
medac Gesellschaft für klinische Spezialpräparate mbH	Arsenic trioxide medac	arsenic trioxide	EMEA/H/C/005218Arsenic trioxide medac is indicated for induction of remission, and consolidation in adult patients with:Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count, ≤ 10 x 10³/μl) in combination with all-trans-retinoic acid (ATRA)Relapsed/refractory APL (previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the pro-myelocytic leukaemia/retinoic-acid-receptor-alpha (PML/RARα) gene.The response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not been examined.	Authorised	yes	no	no	2020-09-17

International Patents for TRISENOX

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

Country	Patent Number	Title	Estimated Expiration
Spain	2395515
Hong Kong	1150762
Portugal	1964557

Last updated: July 27, 2025

rket Dynamics and Financial Trajectory for the Pharmaceutical Drug: Trisenox

Introduction

Trisenox, known generically as arsenic trioxide, is a chemotherapeutic agent primarily used to treat acute promyelocytic leukemia (APL). Approved initially by the U.S. Food and Drug Administration (FDA) in 2000, Trisenox has gained a pivotal role within oncology, driven by its targeted mechanism and clinical efficacy. This analysis explores the evolving market dynamics and financial trajectory of Trisenox, examining key factors influencing its demand, competition landscape, pipeline developments, regulatory environment, and commercial opportunities.

Market Overview and Clinical Niches

Therapeutic Profile and Clinical Adoption

Trisenox's primary indication remains the treatment of relapsed or refractory APL, a rare subtype of acute myeloid leukemia characterized by the presence of the PML-RARα fusion gene. Its uniqueness stems from its ability to induce differentiation and apoptosis in malignant cells by targeting the PML-RARα fusion protein. The drug’s efficacy, combined with its relatively favorable safety profile, has established it as a critical salvage therapy for patients resistant to conventional chemotherapy.

Market Size and Demand Drivers

The global leukemia treatment market was valued at approximately USD 13 billion in 2021, with the acute myeloid leukemia segment, including APL, comprising a substantial subset (Grand View Research, 2022). Despite APL's rarity, the overall patient population eligible for arsenic trioxide therapy remains steady, with annual incidence rates estimated at 0.15–0.20 cases per 100,000 individuals worldwide. Official prevalence statistics indicate a limited but consistent patient pool, primarily in developed regions with robust diagnostic capabilities.

Demand for Trisenox hinges on several factors:

• Clinical guidelines endorsing arsenic trioxide as frontline or consolidation therapy for APL.
• Treatment guidelines updates reflecting emerging research supporting combined regimens (e.g., arsenic trioxide with all-trans retinoic acid).
• Compact treatment courses leading to increased outpatient administration and better patient compliance.
• Conversion of relapsed cases to remission, sustaining ongoing demand.

Market Dynamics Shaping Trisenox’s Trajectory

Competitive Landscape and Alternatives

While arsenic trioxide remains the standard for many APL cases, emerging therapies threaten its market position:

• Oral formulations: De novo development of oral arsenic compounds promises improved convenience and compliance.
• Targeted agents: Novel drugs such as gemtuzumab ozogamicin, and ongoing research into FLT3 inhibitors and other targeted treatments, might shift treatment paradigms.
• Generic Entrants: Patent expiration has led to the emergence of generic versions, exerting downward pressure on prices and margins.
• Combination therapies: Growing adoption of combination regimens incorporating arsenic trioxide with other agents to enhance efficacy may influence market share.

Regulatory and Reimbursement Environment

Regulatory clarity and reimbursement policies significantly influence market penetration. Increased approval of arsenic trioxide for broader indications, such as maintenance therapy, could expand its use. Conversely, pricing pressures from payers and healthcare systems in North America and Europe challenge profitability. Notably, the rapid advancement of biosimilars and generics affects Trisenox’s market size; however, regulatory pathways for such products are complex due to arsenic's toxicity profile.

Pipeline Developments and Future Outlook

Current pipelines focus on improving arsenic trioxide's delivery and safety:

• Novel formulations culminating in oral or subcutaneous options.
• Combination approaches with immune checkpoint inhibitors or targeted agents.
• Biomarker-driven treatments enhancing patient stratification.
  While no direct competitors currently threaten arsenic trioxide's niche, ongoing research into alternative agents for APL and other hematologic malignancies could reshape future dynamics.

Financial Trajectory Analysis

Revenue Trends

Historical revenue figures for Trisenox reflect a stable yet modest trend, driven by its niche indication. In 2021, the estimated global sales were approximately USD 100-150 million, reflecting its limited but consistent patient cohort (EvaluatePharma). Factors influencing revenue include:

• Patent status and generic competition.
• Adoption rate within treatment guidelines.
• Expansion into potential off-label uses or new indications.

Impact of Patent Expiry and Generics

The expiration of key patents has introduced generics, resulting in pricing pressures and reduced revenue margins. Nonetheless, manufacturers continue to benefit from clinical expertise, specialized formulations, and established clinical protocols that sustain revenue streams.

Market Expansion Opportunities

Potential growth avenues encompass:

• Broader indications: Investigations into arsenic trioxide for other hematologic and solid tumors.
• Geographic expansion, particularly into emerging markets, where reimbursement policies are evolving.
• Enhanced formulations: Oral arsenic variants could facilitate outpatient use, increasing patient access and provider adoption.

Regulatory and Policy Factors

Global Regulatory Landscape

Regulatory authorities' receptiveness to arsenic trioxide varies:

• The FDA and EMA maintain stringent safety monitoring owing to arsenic’s toxicity.
• Approvals for new formulations or expanded indications could bolster use.
• Accelerated approvals and orphan drug designations may streamline pathways in select jurisdictions.

Reimbursement Climate

Limited affordability in certain regions constrains access, especially as generic competition drives prices downward. Reimbursement policies favoring cost-effective, outpatient regimens could benefit Trisenox’s market penetration.

Market Challenges and Risks

• Toxicity management: Long-term safety concerns, especially related to arsenic exposure and differentiation syndrome, necessitate vigilant monitoring.
• Off-label use and unapproved formulations: These pose regulatory and safety risks, potentially impacting market stability.
• Emerging targeted therapies with potentially superior efficacy or convenience could reduce reliance on arsenic trioxide.
• Pricing and reimbursement pressures threaten profit margins, especially amid increased competition.

Strategic Opportunities

• Invest in oral formulations to serve outpatient markets.
• Engage in clinical trials exploring new combination therapies to expand therapeutic scope.
• Enhance global distribution through partnerships in emerging markets.
• Leverage orphan drug status to incentivize research and extend patent exclusivity where applicable.

Key Takeaways

• Trisenox remains a vital agent in the treatment of relapsed/refractory APL, with stable demand driven by established clinical protocols.
• Patent expirations and the advent of generics compress revenue margins but open opportunities for broader market access, especially with novel formulations.
• Market competition from emerging targeted agents, oral formulations, and combination therapies could alter its positioning.
• Regulatory pathways, reimbursement policies, and safety considerations are critical determinants of its future market trajectory.
• Strategic investments in formulation innovation, clinical research, and geographic expansion will be pivotal to maintaining and growing Trisenox’s market share.

Conclusion

Trisenox’s market trajectory underscores a niche yet resilient segment within hematologic oncology. While facing challenges from generic competition and evolving therapeutic paradigms, strategic product innovation and expanded clinical applications could sustain its relevance. Continuous monitoring of regulatory developments and competitor innovations is vital for stakeholders seeking to optimize investment and operational decisions.

---

FAQs

1. What is the primary indication for Trisenox?
Trisenox is primarily indicated for the treatment of relapsed or refractory acute promyelocytic leukemia (APL), especially in cases resistant to standard chemotherapy.

2. How does arsenic trioxide work mechanistically?
Arsenic trioxide induces apoptosis and promotes differentiation by targeting the PML-RARα fusion protein, a hallmark of APL, thereby restoring normal cell maturation pathways.

3. What are the main challenges facing Trisenox’s market growth?
Challenges include patent expirations leading to generic competition, safety concerns related to arsenic toxicity, competition from emerging therapies, and reimbursement pressures.

4. Are there ongoing developments to improve Trisenox’s efficacy or safety?
Yes, research focuses on oral formulations, combination regimens, and novel delivery systems aimed at improving patient compliance and minimizing toxicity.

5. What strategic moves can manufacturers consider to sustain Trisenox’s market presence?
Investments in oral formulations, expanding indications, entering emerging markets, and participating in clinical trials for combination strategies are key tactics.

---

Sources:
[1] Grand View Research. "Leukemia Treatment Market Size & Trends," 2022.
[2] EvaluatePharma. "Global Oncology Drug Sales Data," 2021.
[3] FDA Drug Approval Records. "Arsenic Trioxide (Trisenox) Approval Summary," 2000.
[4] Clinical guidelines and recent publications on APL management.