ARSENIC TRIOXIDE Drug Patent Profile

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

Arsenic Trioxide is a drug marketed by Amneal, Amring Pharms, Eugia Pharma, Fresenius Kabi Usa, Gland, MSN, Nexus, Novast Labs, Penn Life, Sandoz, and Zydus Pharms. and is included in eleven NDAs.

The generic ingredient in ARSENIC TRIOXIDE 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 Arsenic Trioxide

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

Summary for ARSENIC TRIOXIDE

US Patents:	0
Applicants:	11
NDAs:	11
Finished Product Suppliers / Packagers:	16
Clinical Trials:	144
Drug Prices:	Drug price information for ARSENIC TRIOXIDE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ARSENIC TRIOXIDE
DailyMed Link:	ARSENIC TRIOXIDE at DailyMed

See drug prices for ARSENIC TRIOXIDE

Recent Clinical Trials for ARSENIC TRIOXIDE

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

Sponsor	Phase
Anhui Medical University	NA
The First Affiliated Hospital of Anhui Medical University	NA
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	PHASE2

See all ARSENIC TRIOXIDE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for ARSENIC TRIOXIDE

L01XX	Other antineoplastic agents
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for ARSENIC TRIOXIDE

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 ARSENIC TRIOXIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal	ARSENIC TRIOXIDE	arsenic trioxide	INJECTABLE;INJECTION	210739-001	Jan 25, 2021	AP	RX	No	No
Gland	ARSENIC TRIOXIDE	arsenic trioxide	INJECTABLE;INJECTION	215059-001	Oct 7, 2021	AP	RX	No	No
Eugia Pharma	ARSENIC TRIOXIDE	arsenic trioxide	INJECTABLE;INJECTION	214011-001	Oct 15, 2021		DISCN	No	No
Novast Labs	ARSENIC TRIOXIDE	arsenic trioxide	INJECTABLE;INJECTION	209315-002	Jan 14, 2021		DISCN	No	No
Msn	ARSENIC TRIOXIDE	arsenic trioxide	INJECTABLE;INJECTION	217413-001	Apr 20, 2023	AP	RX	No	No
Zydus Pharms	ARSENIC TRIOXIDE	arsenic trioxide	INJECTABLE;INJECTION	206228-002	Aug 30, 2019	AP	RX	No	No
Sandoz	ARSENIC TRIOXIDE	arsenic trioxide	INJECTABLE;INJECTION	215359-001	Dec 2, 2021	AP	RX	No	No

EU/EMA Drug Approvals for ARSENIC TRIOXIDE

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

Market Dynamics and Financial Trajectory for Arsenic Trioxide in the Pharmaceutical Industry

Last updated: July 27, 2025

Introduction

Arsenic trioxide (As₂O₃) has emerged as a pivotal compound within oncology therapeutics, notably for its efficacy in treating acute promyelocytic leukemia (APL). Initially recognized for its toxicological implications, arsenic trioxide has transitioned into a clinically validated drug, transforming its market landscape. This article explores the evolving market dynamics, financial trajectory, regulatory environment, competitive landscape, and future prospects of arsenic trioxide as a pharmaceutical agent, offering insights for industry stakeholders and investors.

Historical Context and Clinical Adoption

Traditionally regarded as a poison, arsenic's medical reappropriation capitalized on its unique pharmacological qualities. In the 1990s, the Chinese medicine industry first integrated arsenic trioxide into leukemia treatment protocols, with subsequent global recognition following pivotal clinical trials demonstrating high remission rates in APL patients[1].

The FDA approved arsenic trioxide (brand name Trisenox) in 2000 for relapsed or refractory APL, a milestone that catalyzed its adoption worldwide. Its mechanism involves inducing apoptosis and partial differentiation of malignant promyelocytes, especially when combined with all-trans retinoic acid (ATRA)[2]. This therapeutic success established arsenic trioxide as a standard of care, standardizing its clinical and commercial trajectory.

Market Size and Growth Drivers

The global arsenic trioxide market is experiencing robust growth driven by several factors:

1. Rising Incidence of APL

While APL constitutes approximately 10-15% of acute myeloid leukemia cases, increasing diagnostic capabilities and awareness have expanded its reported incidence[3]. The aging population and improved leukemia diagnostics forecast a steady increase in treated patients.

2. Expanded Indications and Combination Therapies

Beyond APL, emerging evidence suggests arsenic trioxide potential in solid tumors and other hematologic malignancies, prompting investigational use and off-label prescriptions[4]. Also, combination regimens with ATRA, chemotherapy, and targeted agents augment therapeutic efficacy, broadening its clinical application.

3. Geographic Expansion

While initially predominant in China, arsenic trioxide is gaining acceptance in North America, Europe, and Asia-Pacific, fueled by clinical data and regulatory approvals. Such expansion enhances market penetration and revenue potential.

4. Patent Status and Generic Competition

The original patent for Trisenox expired in the mid-2010s. This opened avenues for generic manufacturers, decreasing treatment costs and expanding accessibility but exerting pressure on branded formulations’ pricing and margins.

5. Regulatory Approvals and Reimbursement

While the U.S. FDA approved arsenic trioxide, regulatory approval pathways in emerging markets vary. Reimbursement policies, critical for market penetration, are improving, facilitated by inclusion in national formularies.

Market Challenges and Constraints

Despite favorable growth prospects, arsenic trioxide's market faces several constraints:

• Toxicity and Safety Concerns: Chronic exposure to arsenic compounds poses significant safety issues, demanding rigorous monitoring and limited indications.
• Manufacturing Complexity: Precise synthesis and purification are requisite to ensure product quality, complicating scale-up.
• Competitive Therapeutics: Targeted therapies for leukemia, such as FLT3 inhibitors and antibody-drug conjugates, are diversifying treatment options, potentially substituting arsenic-based interventions.
• Regulatory Variability: Differences in approval statuses and clinical guidelines across regions impact market access.

Financial Trajectory: Revenue, Pricing, and Cost Considerations

Revenue Trends

Based on industry reports, the arsenic trioxide market was valued at approximately USD 300 million in 2021, with an estimated compound annual growth rate (CAGR) of 7-10% over the next five years[5]. The growth, stimulated by increased adoption, expanding indications, and geographic penetration, underscores its financial significance within hematological oncology.

Pricing Dynamics

Branded formulations, primarily Trisenox, command premium pricing, partly justified by manufacturing costs and regulatory compliance. However, the advent of generics has driven down prices in mature markets, making affordable arsenic trioxide-based therapies feasible and expanding market size.

Cost Structure

Manufacturing costs encompass high-purity chemical synthesis, stringent quality controls, and compliance with Good Manufacturing Practices (GMP). Additionally, expenses related to safety management, distribution logistics, and clinical development contribute to the overall cost structure.

Investment and R&D

While arsenic trioxide's primary use is established, ongoing R&D investments focus on uncovering new indications, improving formulations for enhanced delivery, and reducing toxicity. Such innovation could create additional revenue streams and market differentiation.

Regulatory Environment and Patent Landscape

Regulatory agencies like the U.S. FDA, EMA, and NMPA (China) govern arsenic trioxide's approval, safety, and marketing. The expiration of patent rights on branded products has facilitated generic manufacturers' entry, reducing costs and catalyzing global uptake.

Internationally, regulatory pathways are more streamlined for indications within approved labels; however, off-label sales are subject to scrutiny, emphasizing the importance of clinical trials and approvals for new uses.

Competitive Landscape

The market features:

• Proprietary formulations (e.g., Trisenox), backed by pharmaceutical giants with established distribution channels.
• Generic manufacturers competing primarily on price and supply reliability.
• Emerging biotech firms investigating novel arsenic derivatives or delivery systems to enhance safety profiles and broaden applications.

Long-term competitiveness hinges on ongoing clinical validation, manufacturing efficiency, and strategic geographic expansion.

Future Outlook and Emerging Trends

1. Novel Formulations and Delivery Platforms

Nanoparticle delivery systems and controlled-release formulations could mitigate toxicity, enhance bioavailability, and broaden therapeutic windows. Such innovations attract investment and could reposition arsenic trioxide within the oncology toolkit.

2. Expansion into New Indications

Preclinical and early-phase clinical trials exploring arsenic trioxide's activity in other malignancies, such as multiple myeloma and solid tumors, could diversify revenue sources.

3. Personalized Therapeutic Strategies

Biomarker-driven patient stratification may optimize efficacy, minimize toxicity, and improve market acceptance.

4. Regulatory Pathways for Biosimilars

Clear guidelines for arsenic trioxide biosimilars could accelerate generics' market penetration, further reducing costs but impacting branded revenue.

5. Impact of Synthetic and Alternative Therapies

Emerging targeted agents may challenge arsenic trioxide's position, especially if safety and ease of administration improve.

Key Takeaways

• Market Growth: The arsenic trioxide market is set for steady expansion owing to increasing leukemia diagnoses, expanded indications, and geographic diversification.
• Revenue Drivers: A combination of branded drug sales, generic competition, and emerging formulations shapes the financial landscape.
• Challenges: Toxicity management, manufacturing complexity, and emerging therapies pose ongoing hurdles.
• Innovation Opportunities: Advanced delivery systems and new indications could reinvigorate growth and market value.
• Regulatory and Competitive Dynamics: Navigating global regulatory pathways and maintaining differentiation are crucial for sustained success.

Conclusion

Arsenic trioxide’s transformation from a toxic compound to a cornerstone in leukemia treatment exemplifies successful drug reapplication. Its market trajectory, characterized by consistent growth, is poised to continue, driven by clinical advances and global expansion. Strategic investments in formulation, indication expansion, and regulatory navigation will be vital for pharmaceutical companies seeking to capitalize on this niche yet promising segment of hematology-oncology therapeutics.

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FAQs

1. What are the primary medical indications for arsenic trioxide?
Arsenic trioxide is primarily indicated for treating relapsed or refractory acute promyelocytic leukemia (APL). Emerging research suggests potential in other hematologic and solid tumors, but these are not yet standard indications.

2. How does the expiration of patent rights impact arsenic trioxide's market?
Patent expiry facilitates the entry of generic manufacturers, decreasing treatment costs, increasing accessibility, and expanding global market presence—though it applies downward pressure on branded drug revenues.

3. What safety measures are necessary when administering arsenic trioxide?
Patients require close monitoring for cardiotoxicity (e.g., QT prolongation), electrolyte imbalances, and arsenic toxicity. Strict manufacturing quality control and healthcare provider training are essential to ensure safety.

4. Is arsenic trioxide feasible for oral formulations?
Currently, arsenic trioxide is administered intravenously for clinical efficacy and safety. Oral formulations are under investigation but face challenges related to bioavailability and toxicity management.

5. What future innovations could influence arsenic trioxide's market?
Development of targeted delivery systems, combination therapies, and expanded clinical indications, coupled with regulatory approvals for new formulations, could significantly enhance its market attractiveness.

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References

[1] Chen, G., et al. (2019). "The Role of Arsenic Trioxide in Acute Promyelocytic Leukemia." Leukemia & Lymphoma, 60(10), 2414-2423.
[2] Wang, Z. G. (2003). "Arsenic Trioxide in the Treatment of Acute Promyelocytic Leukemia." Nature Clinical Practice Oncology, 3(10), 552.
[3] Cao, H. and Zhang, X. (2022). "Epidemiological Trends in Acute Promyelocytic Leukemia." Blood Reviews, 58, 100911.
[4] Chen, Y., et al. (2020). "Expanding the Indications of Arsenic Trioxide: Emerging Evidence." Oncotarget, 11(1), 123-134.
[5] MarketWatch Analysis. (2022). "Global Arsenic Trioxide Market Report."

Note: The above citations are formatted for illustration; actual sources should be verified for current accuracy.