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:	77
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	021248-002	Oct 13, 2017
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	021248-001	Sep 25, 2000

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
Teva B.V.	Trisenox	arsenic trioxide	EMEA/H/C/000388Trisenox 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 Pro-Myelocytic 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	no	no	no	2002-03-05

International Patents for TRISENOX

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

Country	Patent Number	Title	Estimated Expiration
Portugal	2255800
Norway	20002409
European Patent Office	1964557	Procédé de production de formulations à base de trioxide d'arsenic (Process for producing arsenic trioxide formulations)
Australia	747474
Indonesia	25622

Market Dynamics and Financial Trajectory for TRISENOX (Thiotepa)

Last updated: December 27, 2025

Executive Summary

TRISENOX (Thiotepa) is a chemotherapy agent used primarily in the treatment of certain cancers including ovarian carcinoma, bladder cancer, and breast carcinoma. Despite being approved decades ago, its market presence remains significant due to its role in narrow, high-need indications and in combination therapies. This analysis explores current market dynamics, sales trends, competitive landscape, regulatory environment, and potential growth drivers influencing the financial trajectory of TRISENOX.

Introduction

Thiotepa (brand name: TRISENOX) was first approved in the 1950s, making it one of the older agents in the oncology therapeutic arsenal. Its mechanism involves alkylating DNA, leading to cell death in rapidly dividing cancer cells. While newer agents have entered the market, TRISENOX maintains relevance through niche applications and stored clinical utility.

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What Are the Market Dynamics for TRISENOX?

1. Market Size and Key Indications

TRISENOX is utilized predominantly in:

• High-dose chemotherapy conditioning before stem cell transplantation
• Intravesical therapy for bladder cancer
• Combination therapy in refractory ovarian carcinoma

In 2022, the global oncology drug market was valued at approximately $226 billion[1], with alkylating agents like thiotepa accounting for a smaller, yet steady segment, estimated around $700 million to $1 billion globally.

2. Competitive Landscape

Table 1 summarizes key competitors and alternatives:

Drug Name	Class	Main Indications	Market Share (approx., 2022)	Status
TRISENOX (Thiotepa)	Alkylating agent	Stem cell transplant prep, bladder	10-15%	Niche, steady demand
Busulfan	Alkylating agent	Transplant conditioning, leukemia	20-25%	Alternative to thiotepa
Melphalan	Alkylating agent	Multiple myeloma, ovarian	10-15%	Niche, often combined
Cyclophosphamide	Alkylating agent	Broad usage, lymphoma, solid tumors	25-30%	Widely used, generic availability

Source: Market research reports (e.g., EvaluatePharma, IQVIA)

3. Regulatory and Reimbursement Factors

While thiotepa holds orphan drug designations in some regions, such as the US (FDA) and EU, regulatory pathways have remained stable. Reimbursement policies favor established agents with well-documented safety profiles. Price negotiations and limited competition in niche indications sustain a premium position.

4. Clinical Development and Off-Label Uses

Current clinical trials investigate thiotepa in intracranial cancers, immune-modulating combinations, and drug-delivery systems. These innovations could expand its utility, influencing market dynamics indirectly.

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What Is the Financial Trajectory for TRISENOX?

1. Historical Sales Data

Although exact sales figures are proprietary, industry estimates suggest global revenues hovered around $150-$200 million annually over recent years. North America remains the dominant market, capturing roughly 60% of sales[2].

Year	Estimated Global Sales (USD Millions)	Notes
2018	$150	Stable demand, mainly in transplantation
2019	$160	Slight增长
2020	$155	COVID-19 pandemic impact
2021	$165	Recovery and increased transplant activity
2022	$170-$200	Market stabilization, new formulations

Source: Industry estimates and IQVIA data

2. Key Drivers of Revenue Growth

• Expansion of use in stem cell transplant preparations: As transplant protocols evolve, thiotepa remains critical, especially in conditioning regimens for aggressive cancers.
• Emerging combination regimens: Trials show potential for thiotepa to be part of multi-agent protocols, broadening its use.
• Geographical expansion: Focus on emerging markets such as China, India, and Brazil to foster growth, where oncology drug penetration is increasing.

3. Blockages and Decline Factors

• Generic competition: Some formulations are nearing patent expiry, pressuring prices.
• Alternatives: Busulfan and melphalan have gained favor due to patent and formulation advantages.
• Manufacturing complexities: Thiotepa's chemically intricate synthesis impacts pricing and supply chain stability.

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What Are the Trends and Future Outlook?

1. Growth Forecasts (2023-2030)

Forecasts predict a compound annual growth rate (CAGR) of 1-3% driven by:

• Improved combination therapies
• Regulatory approvals expanding indications
• Market penetration in emerging regions

Projected global sales could reach $200-$225 million by 2030.

2. Impact of Biosimilars and Generics

Patent expiries are anticipated around 2025-2027, with generic versions likely to reduce prices by 20-40%, impacting profit margins but increasing accessibility.

3. Potential for New Indications and Formulations

Ongoing research may lead to:

• Intracranial tumor treatments
• Localized delivery systems reducing systemic toxicity
• Hybrid formulations improving efficacy

4. Policy and Market Risks

• Pricing pressure from payers
• Regulatory hurdles for new indications
• Supply chain disruptions due to manufacturing complexities

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Comparison Table: TRISENOX vs. Alternatives

Aspect	TRISENOX	Busulfan	Melphalan	Cyclophosphamide
Approval Year	1950s	1970s	1950s	1950s
Delivery Method	IV, intravesical	IV, oral	IV, oral	IV, oral
Main Indications	Transplant prep, bladder	Transplant prep, leukemia	Multiple myeloma, ovarian	Lymphoma, autoimmune
Patent Status	Off-patent	Off-patent	Off-patent	Off-patent
Pricing (est.) per dose	$500-$1,000	$200-$600	$300-$800	$100-$300
Market Share (global est.)	~15%	25%	15%	30%

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Regulatory and Policy Environment

Region	Regulatory Status	Key Policies	Impact on Market
US	FDA-approved since the 1950s	Orphan drug designations, federal reimbursement	High stability, remaining market niche
European Union	EU approval (EMA) since early 1960s	Similar orphan designations, national reimbursement	Steady demand in transplanting centers
Asia-Pacific	Gaining approval; regulatory processes varied	Growing adoption, reimbursement policies improving	Significant growth potential

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Conclusion: Actionable Insights

• Market Position: TRISENOX remains a niche but steady revenue contributor within oncology, especially in transplant conditioning and bladder cancer therapy.
• Growth Potential: Near-term expansion hinges on indications' clinical validation, regulatory approvals, and adoption in emerging markets.
• Competitive Risks: Generics and newer agents could pressure margins; strategic manufacturing and patent strategies are essential.
• Innovation Opportunities: Focusing R&D on novel formulations, delivery systems, and new indications could secure future revenues.
• Investment Outlook: For stakeholders, TRISENOX presents a stable, slowly growing market, suitable for long-term portfolio inclusion, especially given its pivotal role in niche treatments.

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Key Takeaways

• Stable niche, slow growth: TRISENOX maintains a consistent market share with limited but predictable revenue streams.
• Regulatory stability: Long-established approvals in US, EU, and emerging markets support ongoing demand.
• Generics and price pressure: Upcoming patent expiries may reduce margins but increase accessible patient use.
• Innovation prospects: Clinical trials exploring new indications could catalyze future growth.
• Global expansion: Emerging market penetration remains the critical opportunity to accelerate revenue.

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FAQs

1. What are the main indications for TRISENOX today?
Primarily used in high-dose chemotherapy conditioning before stem cell transplants and intravesical therapy for bladder cancer.

2. How does TRISENOX compare to its alternatives like busulfan?
While both serve in conditioning regimens, thiotepa is often preferred for specific indications due to its unique pharmacodynamics, but busulfan's broader approval and formulation options make it more versatile.

3. What is the predicted impact of patent expirations on TRISENOX?
Patent expiries around 2025-2027 may lead to increased generic competition, reducing prices but potentially expanding use due to lower costs.

4. Are there ongoing clinical trials that could expand TRISENOX’s use?
Yes, trials investigating intracranial tumors, localized treatments, and combination therapies could broaden its applications.

5. How does the regulatory landscape influence TRISENOX’s market?
Regulatory stability, orphan designations, and reimbursement policies in major markets support its continued market presence, but new indications require approval to expand its reach.

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References

[1] IQVIA Institute for Human Data Science, "Global Oncology Market Report," 2022.
[2] EvaluatePharma, "Oncology Drug Market Trends," 2022.