Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

Merck
Johnson and Johnson
McKesson
Baxter
Moodys
Express Scripts

Last Updated: November 29, 2022

Arsenic trioxide - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


What are the generic drug 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 Pharms, Sandoz Inc, Sti Pharma Llc, Zydus Pharms, and Cephalon, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

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

Drug Prices for arsenic trioxide

See drug prices for arsenic trioxide

Recent Clinical Trials for arsenic trioxide

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

SponsorPhase
Hospital Universitario Dr. Jose E. GonzalezPhase 1/Phase 2
Syros PharmaceuticalsPhase 1
Ruijin HospitalPhase 2

See all arsenic trioxide clinical trials

Generic filers with tentative approvals for ARSENIC TRIOXIDE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing10MLINJECTABLE; INJECTION

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

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
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
Amneal ARSENIC TRIOXIDE arsenic trioxide INJECTABLE;INJECTION 210739-001 Jan 25, 2021 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sti Pharma Llc ARSENIC TRIOXIDE arsenic trioxide INJECTABLE;INJECTION 209873-001 May 6, 2019 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ingenus Pharms Llc ARSENIC TRIOXIDE arsenic trioxide INJECTABLE;INJECTION 209315-002 Jan 14, 2021 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sandoz Inc ARSENIC TRIOXIDE arsenic trioxide INJECTABLE;INJECTION 215359-001 Dec 2, 2021 AP RX No No 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 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 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Baxter
Merck
Mallinckrodt
Medtronic
Harvard Business School
Moodys

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.