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Last Updated: August 17, 2022

TRISENOX Drug Patent Profile


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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. Thirteen 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 31st, 2018.

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Drug patent expirations by year for TRISENOX
Drug Prices for TRISENOX

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Recent Clinical Trials for TRISENOX

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

SponsorPhase
Jean Yuh TangEarly Phase 1
National Cancer Institute (NCI)Early Phase 1
Orsenix LLCPhase 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.

FDA Regulatory Exclusivity protecting TRISENOX

ARSENIC TRIOXIDE FOR USE IN COMBINATION WITH TRETINOIN FOR TREATMENT OF ADULTS WITH NEWLY-DIAGNOSED LOW-RISK ACUTE PROMYELOCYTIC LEUKEMIA (APL) WHOSE APL IS CHARACTERIZED BY THE PRESENCE OF THE T(15;17) TRANSLOCATION OR PML/RAR-ALPHA GENE EXPRESSION
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Cephalon TRISENOX arsenic trioxide INJECTABLE;INJECTION 021248-002 Oct 13, 2017 AP RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for TRISENOX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cephalon TRISENOX arsenic trioxide INJECTABLE;INJECTION 021248-001 Sep 25, 2000 See Plans and Pricing See Plans and Pricing
Cephalon TRISENOX arsenic trioxide INJECTABLE;INJECTION 021248-001 Sep 25, 2000 See Plans and Pricing See Plans and Pricing
Cephalon TRISENOX arsenic trioxide INJECTABLE;INJECTION 021248-002 Oct 13, 2017 See Plans and Pricing See Plans and Pricing
Cephalon TRISENOX arsenic trioxide INJECTABLE;INJECTION 021248-002 Oct 13, 2017 See Plans and Pricing See Plans and Pricing
Cephalon TRISENOX arsenic trioxide INJECTABLE;INJECTION 021248-001 Sep 25, 2000 See Plans and Pricing See Plans and Pricing
Cephalon TRISENOX arsenic trioxide INJECTABLE;INJECTION 021248-002 Oct 13, 2017 See Plans and Pricing See Plans and Pricing
Cephalon TRISENOX arsenic trioxide INJECTABLE;INJECTION 021248-002 Oct 13, 2017 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for TRISENOX

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

Country Patent Number Title Estimated Expiration
Cyprus 1113856 See Plans and Pricing
Spain 2399480 See Plans and Pricing
Canada 2309652 PROCEDE DE PRODUCTION DE FORMULATIONS A BASE DE TRIOXYDE D'ARSENIC ET METHODES DE THERAPIE ANTICANCEREUSE UTILISANT DU TRIOXYDE D'ARSENIC OU DU MELARSOPROL (PROCESS FOR PRODUCING ARSENIC TRIOXIDE FORMULATIONS AND METHODS FOR TREATING CANCER USING ARSENIC TRIOXIDE OR MELARSOPROL) See Plans and Pricing
Israel 136051 See Plans and Pricing
Poland 343868 See Plans and Pricing
Hong Kong 1150762 See Plans and Pricing
Australia 1397399 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.