TRISENOX Drug Patent Profile

Which patents cover Trisenox, 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:	9
Clinical Trials:	38
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	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 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/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

International Patents for TRISENOX

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1964557	Procédé de production de formulations à base de trioxide d'arsenic (Process for producing arsenic trioxide formulations)
Indonesia	25622
Norway	20002409
Spain	2395515
Portugal	2255800
Brazil	9814857

TRISENOX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Trisenox (Arsenic Trioxide)

Introduction

Trisenox, also known as arsenic trioxide, is a crucial chemotherapeutic agent used in the treatment of acute promyelocytic leukemia (APL), a rare and aggressive form of leukemia. The market dynamics for Trisenox are influenced by several key factors, including disease prevalence, advancements in leukemia research, regulatory landscapes, and economic considerations.

Market Overview

The Trisenox market is an essential segment within the pharmaceutical industry, particularly in oncology therapeutics. The drug has emerged as a cornerstone therapy for APL, offering improved outcomes and survival rates for patients. Trisenox works by inducing apoptosis (cell death) in leukemia cells, often used in combination with other chemotherapy agents like all-trans retinoic acid (ATRA)[4].

Driving Factors

Several factors drive the growth of the Trisenox market:

Increasing Incidence of Acute Promyelocytic Leukemia

The rising incidence of APL globally is a significant driver. As cancer cases increase, the demand for effective treatments like Trisenox also rises[1][2].

Advancements in Combination Therapy

Advancements in combination therapies, where Trisenox is used alongside other agents, have enhanced its efficacy and safety profile. This has led to increased adoption in clinical practice guidelines[2][4].

Regulatory and Research Environment

Robust research infrastructure, favorable reimbursement policies, and standardized treatment guidelines in regions like North America and Europe support market growth. Growing healthcare investments in the Asia Pacific region also contribute to market expansion[4].

Impact of COVID-19

The COVID-19 pandemic has raised concerns about the rise in cancer and related chronic diseases, leading to increased investments in the treatment of these diseases. This has indirectly boosted the demand for Trisenox and other cancer treatments[1].

Market Size and Forecast

The global Trisenox market is projected to experience steady growth:

• The market size was valued at approximately USD 26.78 million in 2023 and is expected to reach USD 38.65 million by 2032, exhibiting a Compound Annual Growth Rate (CAGR) of 3.74%[2].
• Another forecast suggests a CAGR of 3 to 5 percent from 2024 to 2031, indicating a consistent growth trajectory[5].

Segmentation

The Trisenox market can be segmented in several ways:

By Product

The market is segmented based on the concentration of arsenic trioxide, typically 1mg/mL and 2mg/mL[5].

By Application

The market is segmented based on the application settings, such as hospitals and pharmacies[5].

By Geography

Geographic segmentation includes regions like North America, Europe, Asia-Pacific, and Latin America. Each region has its unique market dynamics influenced by local disease prevalence, treatment patterns, and regulatory landscapes[4].

By Patient Demographics

Segmentation based on patient demographics like age, gender, and genetic predisposition helps in targeted marketing and patient outreach initiatives[4].

Competitive Landscape

The Trisenox market features a competitive landscape with established pharmaceutical companies, emerging biotechnology firms, and academic research institutions. Key players leverage their scientific expertise, clinical trial data, and commercialization strategies to maintain market leadership and drive innovation[4].

Challenges and Limitations

Despite the growth potential, the Trisenox market faces several challenges:

Side Effects and Toxicities

Chemotherapy-related side effects such as nausea, vomiting, and mouth sores are significant concerns. These side effects can impact patient compliance and overall market growth[1].

High Development and Delivery Costs

The high costs associated with the design, development, and delivery of Trisenox limit its market penetration in populations with lower purchasing power parity[1].

Lack of Awareness

In underdeveloped regions, lack of awareness about APL and its treatment options can hinder market growth[1].

Regional Analysis

North America

Driven by robust research infrastructure, high disease prevalence, and favorable reimbursement policies, the North American market is a significant contributor to the global Trisenox market[4].

Europe

European markets benefit from standardized treatment guidelines, regulatory harmonization, and strong academic collaborations, facilitating market access and adoption[4].

Asia Pacific

Growing healthcare investments, increasing disease awareness, and expanding market opportunities in countries like China and India drive market growth in this region[4].

Latin America

Improving healthcare infrastructure, rising APL incidence rates, and increasing access to innovative therapies foster market development and investment opportunities in Latin America[4].

Financial Trajectory

The financial trajectory of the Trisenox market is characterized by steady growth driven by increasing demand and advancements in treatment protocols.

• Revenue Growth: The market is expected to grow from USD 26.78 million in 2023 to USD 38.65 million by 2032, indicating a stable revenue growth trajectory[2].
• Investments: Significant investments from both public and private sectors in cancer research and treatment are expected to continue, supporting the financial health of the market[1].

Future Trends

Personalized Medicine

The integration of personalized medicine approaches is expected to shape the future of the Trisenox market, offering more targeted and effective treatment options[4].

Immunotherapy Integration

The potential integration of immunotherapy with traditional chemotherapy agents like Trisenox could enhance treatment outcomes and drive market innovation[4].

Digital Health Solutions

The adoption of digital health solutions is likely to improve patient care, treatment adherence, and overall market efficiency[4].

Key Takeaways

• The Trisenox market is driven by the increasing incidence of APL and advancements in combination therapy.
• The market is expected to grow at a CAGR of 3.74% from 2023 to 2032.
• Regional dynamics, including North America, Europe, and the Asia Pacific, play a crucial role in market growth.
• Challenges such as side effects, high development costs, and lack of awareness need to be addressed.
• Future trends include personalized medicine, immunotherapy integration, and digital health solutions.

FAQs

What is Trisenox used for?

Trisenox, or arsenic trioxide, is used in the treatment of acute promyelocytic leukemia (APL), a rare and aggressive form of leukemia[4].

What is the expected market size of Trisenox by 2032?

The global Trisenox market is expected to reach USD 38.65 million by 2032[2].

What are the key driving factors for the Trisenox market?

Key driving factors include the increasing incidence of APL, advancements in combination therapy, and the impact of COVID-19 on cancer treatment investments[1][2].

What are the main challenges facing the Trisenox market?

Challenges include chemotherapy-related side effects, high development and delivery costs, and lack of awareness in underdeveloped regions[1].

How is the Trisenox market segmented?

The market is segmented by product concentration, application settings, geography, and patient demographics[5].

Sources

1. Allied Market Research - Trisenox Market Trends, Growth, Size, Share | Report, 2030
2. Global Market Statistics - Trisenox (arsenic trioxide) Market Size, Growth & Forecast
3. Healthcare Finance News - Cancer drug costs on the rise despite pharma competition
4. MarkWide Research - Trisenox market 2024-2032 | Size, Share, Growth
5. Market Research Intellect - Trisenox Market Size And Forecast