You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 22, 2024

ARSENIC TRIOXIDE Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Arsenic Trioxide patents expire, and when can generic versions of Arsenic Trioxide launch?

Arsenic Trioxide is a drug marketed by Amneal, Amring Pharms, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Ingenus Pharms Llc, Nexus, Orbicular, Penn Life, Sandoz, and Zydus Pharms. and is included in eleven NDAs.

The generic ingredient in ARSENIC TRIOXIDE 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 Arsenic Trioxide

A generic version of ARSENIC TRIOXIDE was approved as arsenic trioxide by FRESENIUS KABI USA on August 31st, 2018.

  Sign Up

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for ARSENIC TRIOXIDE?
  • What are the global sales for ARSENIC TRIOXIDE?
  • What is Average Wholesale Price for ARSENIC TRIOXIDE?
Drug patent expirations by year for ARSENIC TRIOXIDE
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
Nazarbayev UniversityPhase 1/Phase 2
National Laboratory AstanaPhase 1/Phase 2
The First Affiliated Hospital of Guangzhou Medical UniversityPhase 4

See all ARSENIC TRIOXIDE clinical trials

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
Amneal ARSENIC TRIOXIDE arsenic trioxide INJECTABLE;INJECTION 210739-001 Jan 25, 2021 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Gland Pharma Ltd ARSENIC TRIOXIDE arsenic trioxide INJECTABLE;INJECTION 215059-001 Oct 7, 2021 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Eugia Pharma ARSENIC TRIOXIDE arsenic trioxide INJECTABLE;INJECTION 214011-001 Oct 15, 2021 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity 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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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

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.