Arsenic trioxide - Generic Drug Details

What are the generic sources for arsenic trioxide and what is the scope of freedom to operate?

Arsenic trioxide is the generic ingredient in two branded drugs marketed by Amneal, Amring Pharms, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Ingenus Pharms Llc, Nexus, Orbicular, Penn Life, Sandoz, Zydus Pharms, and Cephalon, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for arsenic trioxide. Seventeen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for arsenic trioxide

US Patents:	0
Tradenames:	2
Applicants:	12
NDAs:	12
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	17
Clinical Trials:	139
Drug Prices:	Drug price trends for arsenic trioxide
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for arsenic trioxide
What excipients (inactive ingredients) are in arsenic trioxide?	arsenic trioxide excipients list
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
National Laboratory Astana	Phase 1/Phase 2
Nazarbayev University	Phase 1/Phase 2
Hainan People's Hospital	Phase 4

See all arsenic trioxide clinical trials

Generic filers with tentative approvals for ARSENIC TRIOXIDE

Applicant	Application No.	Strength	Dosage Form
		10ML	INJECTABLE; INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Zydus Pharms	ARSENIC TRIOXIDE	arsenic trioxide	INJECTABLE;INJECTION	206228-001	Nov 13, 2018	AP	RX	No	No
Sandoz	ARSENIC TRIOXIDE	arsenic trioxide	INJECTABLE;INJECTION	215359-001	Dec 2, 2021	AP	RX	No	No
Eugia Pharma	ARSENIC TRIOXIDE	arsenic trioxide	INJECTABLE;INJECTION	214011-001	Oct 15, 2021	AP	RX	No	No
Penn Life	ARSENIC TRIOXIDE	arsenic trioxide	INJECTABLE;INJECTION	209873-001	May 6, 2019	AP	RX	No	No
Cephalon	TRISENOX	arsenic trioxide	INJECTABLE;INJECTION	021248-002	Oct 13, 2017	AP	RX	Yes	Yes
Fresenius Kabi Usa	ARSENIC TRIOXIDE	arsenic trioxide	INJECTABLE;INJECTION	208231-001	Aug 31, 2018	AP	RX	No	Yes

Expired US Patents for arsenic trioxide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cephalon	TRISENOX	arsenic trioxide	INJECTABLE;INJECTION	021248-002	Oct 13, 2017	6,884,439
Cephalon	TRISENOX	arsenic trioxide	INJECTABLE;INJECTION	021248-001	Sep 25, 2000	6,982,096
Cephalon	TRISENOX	arsenic trioxide	INJECTABLE;INJECTION	021248-002	Oct 13, 2017	6,861,076
Cephalon	TRISENOX	arsenic trioxide	INJECTABLE;INJECTION	021248-001	Sep 25, 2000	6,723,351
Cephalon	TRISENOX	arsenic trioxide	INJECTABLE;INJECTION	021248-002	Oct 13, 2017	6,723,351
Cephalon	TRISENOX	arsenic trioxide	INJECTABLE;INJECTION	021248-002	Oct 13, 2017	6,982,096

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/005235 Arsenic 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/005175 Arsenic 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/005218 Arsenic 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/000388 Trisenox 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

Arsenic trioxide Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Arsenic Trioxide

Introduction

Arsenic trioxide, a compound with a long and complex history, has emerged as a crucial component in the treatment of certain medical conditions, particularly in the field of oncology. This article delves into the market dynamics and financial trajectory of arsenic trioxide, highlighting its current status, future projections, and the factors influencing its growth.

Market Size and Growth Projections

The arsenic trioxide market has been experiencing significant growth in recent years. As of 2023, the market size was valued at USD 2.85 billion and is projected to reach USD 4.15 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 4.1% from 2024 to 2031[1][3][4].

Segmentation of the Market

The arsenic trioxide market is segmented based on type (Type I and Type II) and application (drug manufacturers and laboratory use). Geographically, the market is divided into regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. This segmentation helps in understanding the diverse trends and factors influencing the market in different regions and sectors[3].

Drivers of Market Growth

Several factors are driving the growth of the arsenic trioxide market:

Increasing Demand in Oncology

Arsenic trioxide is primarily used in the treatment of acute promyelocytic leukemia (APL), a type of blood cancer. Its efficacy in combination with all-trans retinoic acid (ATRA) has made it a preferred treatment option, contributing to the market's upward trend[2][5].

Cost-Effectiveness

Studies have shown that arsenic trioxide plus ATRA is a more cost-effective strategy compared to traditional treatments involving chemotherapy. For instance, in Canada, this combination has an incremental cost-effectiveness ratio of approximately $50,000 per quality-adjusted life year (QALY), making it a financially viable option for healthcare systems[2].

Expanding Healthcare Infrastructure

The growth in healthcare infrastructure, especially in emerging economies, is increasing the demand for advanced treatments like arsenic trioxide. This expansion is driven by government investments, private sector participation, and an increasing awareness of healthcare needs[3].

Restraints and Challenges

Despite the positive growth trajectory, the market faces several challenges:

Regulatory Hurdles

Stringent regulatory requirements and the need for rigorous clinical trials can slow down the approval and adoption of arsenic trioxide in new markets. Compliance with international standards and local regulations is a significant challenge[3].

Side Effects and Safety Concerns

Arsenic trioxide can have severe side effects, which may limit its use in certain patient populations. Managing these side effects and ensuring patient safety is a continuous challenge for healthcare providers[5].

Competition from Alternative Treatments

The market is also subject to competition from other treatments and therapies that may emerge as alternatives to arsenic trioxide. The development of new drugs and treatment protocols could potentially impact the market share of arsenic trioxide[3].

Opportunities and Future Outlook

The arsenic trioxide market presents several opportunities for growth and expansion:

Emerging Markets

Countries in the Asia-Pacific region, particularly China, are showing significant potential for growth due to their large patient populations and increasing healthcare expenditures. The cost-effectiveness of arsenic trioxide plus ATRA in the Chinese healthcare system, for example, makes it an attractive option for treating APL patients[5].

Research and Development

Ongoing research and clinical trials are expected to enhance the efficacy and safety profile of arsenic trioxide, potentially expanding its applications beyond APL. Innovations in drug delivery systems and combination therapies could further boost the market[3].

Collaboration and Partnerships

Collaborations between pharmaceutical companies, research institutions, and healthcare providers can accelerate the development and adoption of arsenic trioxide-based treatments. Such partnerships can also help in addressing regulatory and safety challenges[3].

Economic Impact and Cost-Effectiveness

The economic evaluation of arsenic trioxide is a critical aspect of its market dynamics. Studies have consistently shown that the combination of arsenic trioxide and ATRA is cost-effective compared to traditional chemotherapy-based treatments.

Canadian Perspective

In Canada, the incremental cost-effectiveness ratio of arsenic trioxide plus ATRA is approximately $50,000 per QALY, which is considered highly cost-effective from both the Ministry of Health and societal perspectives[2].

Chinese Perspective

In China, the incremental cost-effectiveness ratio is even more favorable, with an estimated $284.02 per QALY gained, which is far below the Chinese willingness-to-pay threshold. This makes the treatment highly cost-effective and recommended by health authorities[5].

Conclusion

The arsenic trioxide market is poised for significant growth driven by its increasing demand in oncology, cost-effectiveness, and expanding healthcare infrastructure. While regulatory hurdles, side effects, and competition from alternative treatments pose challenges, the market offers substantial opportunities for growth, particularly in emerging markets and through research and development.

Key Takeaways

• The arsenic trioxide market is projected to grow from USD 2.85 billion in 2023 to USD 4.15 billion by 2031.
• The market is driven by its use in treating APL and its cost-effectiveness compared to traditional treatments.
• Emerging markets, especially in the Asia-Pacific region, offer significant growth potential.
• Regulatory challenges and side effects are key restraints that need to be addressed.
• Ongoing research and collaborations are expected to enhance the market's growth trajectory.

FAQs

What is the current market size of arsenic trioxide?

The current market size of arsenic trioxide was valued at USD 2.85 billion in 2023[1].

What is the projected growth rate of the arsenic trioxide market?

The arsenic trioxide market is expected to grow at a CAGR of 4.1% from 2024 to 2031[1].

What are the primary applications of arsenic trioxide?

Arsenic trioxide is primarily used in the treatment of acute promyelocytic leukemia (APL) and in laboratory settings[3].

Is arsenic trioxide a cost-effective treatment option?

Yes, arsenic trioxide plus ATRA is considered a cost-effective strategy compared to traditional chemotherapy-based treatments, especially in countries like Canada and China[2][5].

What are the major challenges facing the arsenic trioxide market?

The market faces challenges such as regulatory hurdles, side effects, and competition from alternative treatments[3].

Sources

1. Market Research Intellect, "Arsenic Trioxide Market Size, Trends and Projections".
2. PubMed, "Economic evaluation of arsenic trioxide for treatment of newly diagnosed acute promyelocytic leukaemia".
3. Market Research Intellect, "Global Arsenic Trioxide Market Size, Trends and Projections".
4. Market Research Intellect, "Arsenic Trioxide Injection Market Size, Scope And Forecast Report".
5. PubMed, "The economic research of arsenic trioxide for the treatment of newly diagnosed acute promyelocytic leukemia".