Arsenic trioxide - Generic Drug Details
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What are the generic 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, Orbicular, Penn Life, Sandoz, Zydus Pharms, and Cephalon, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.There are five drug master file entries for arsenic trioxide. Sixteen suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for arsenic trioxide
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 12 |
| NDAs: | 12 |
| Drug Master File Entries: | 5 |
| Finished Product Suppliers / Packagers: | 16 |
| Clinical Trials: | 139 |
| Drug Prices: | Drug price trends for arsenic trioxide |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for arsenic trioxide |
| What excipients (inactive ingredients) are in arsenic trioxide? | arsenic trioxide excipients list |
| DailyMed Link: | arsenic trioxide at DailyMed |
Recent Clinical Trials for arsenic trioxide
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Laboratory Astana | Phase 1/Phase 2 |
| Nazarbayev University | Phase 1/Phase 2 |
| Third Affiliated Hospital, Sun Yat-Sen University | Phase 4 |
Generic filers with tentative approvals for ARSENIC TRIOXIDE
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sandoz | ARSENIC TRIOXIDE | arsenic trioxide | INJECTABLE;INJECTION | 215359-001 | Dec 2, 2021 | 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 | |||
| Ingenus Pharms Llc | ARSENIC TRIOXIDE | arsenic trioxide | INJECTABLE;INJECTION | 209315-002 | Jan 14, 2021 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Orbicular | ARSENIC TRIOXIDE | arsenic trioxide | INJECTABLE;INJECTION | 217413-001 | Apr 20, 2023 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Penn Life | ARSENIC TRIOXIDE | arsenic trioxide | INJECTABLE;INJECTION | 209873-001 | May 6, 2019 | 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 | |||
| Amneal | ARSENIC TRIOXIDE | arsenic trioxide | INJECTABLE;INJECTION | 210739-002 | Aug 19, 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 |
Expired US Patents for arsenic trioxide
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Cephalon | TRISENOX | arsenic trioxide | INJECTABLE;INJECTION | 021248-001 | Sep 25, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Cephalon | TRISENOX | arsenic trioxide | INJECTABLE;INJECTION | 021248-002 | Oct 13, 2017 | ⤷ Sign Up | ⤷ Sign Up |
| Cephalon | TRISENOX | arsenic trioxide | INJECTABLE;INJECTION | 021248-001 | Sep 25, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Cephalon | TRISENOX | arsenic trioxide | INJECTABLE;INJECTION | 021248-002 | Oct 13, 2017 | ⤷ Sign Up | ⤷ Sign Up |
| Cephalon | TRISENOX | arsenic trioxide | INJECTABLE;INJECTION | 021248-002 | Oct 13, 2017 | ⤷ Sign Up | ⤷ Sign Up |
| Cephalon | TRISENOX | arsenic trioxide | INJECTABLE;INJECTION | 021248-002 | Oct 13, 2017 | ⤷ Sign Up | ⤷ Sign Up |
| Cephalon | TRISENOX | arsenic trioxide | INJECTABLE;INJECTION | 021248-002 | Oct 13, 2017 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
