ARSENIC TRIOXIDE Drug Patent Profile
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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. Sixteen 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.
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Summary for ARSENIC TRIOXIDE
| US Patents: | 0 |
| Applicants: | 11 |
| NDAs: | 11 |
| Finished Product Suppliers / Packagers: | 15 |
| Clinical Trials: | 139 |
| Drug Prices: | Drug price information for ARSENIC TRIOXIDE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ARSENIC TRIOXIDE |
| DailyMed Link: | ARSENIC TRIOXIDE at DailyMed |
Recent Clinical Trials for ARSENIC TRIOXIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Nazarbayev University | Phase 1/Phase 2 |
| National Laboratory Astana | Phase 1/Phase 2 |
| Second Xiangya Hospital of Central South University | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for ARSENIC TRIOXIDE
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 | |||
| Orbicular | ARSENIC TRIOXIDE | arsenic trioxide | INJECTABLE;INJECTION | 217413-002 | Apr 20, 2023 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Ingenus Pharms Llc | ARSENIC TRIOXIDE | arsenic trioxide | INJECTABLE;INJECTION | 209315-001 | Nov 15, 2018 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Zydus Pharms | ARSENIC TRIOXIDE | arsenic trioxide | INJECTABLE;INJECTION | 206228-002 | Aug 30, 2019 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sandoz | ARSENIC TRIOXIDE | arsenic trioxide | INJECTABLE;INJECTION | 215359-001 | Dec 2, 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 | |
| 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 |
