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. Sixteen 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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Summary for TRISENOX
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 9 |
| Clinical Trials: | 38 |
| Drug Prices: | Drug price information for TRISENOX |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TRISENOX |
| What excipients (inactive ingredients) are in TRISENOX? | TRISENOX excipients list |
| DailyMed Link: | TRISENOX at DailyMed |
Recent Clinical Trials for TRISENOX
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Hospital Universitario Dr. Jose E. Gonzalez | Phase 1/Phase 2 |
| Jean Yuh Tang | Early Phase 1 |
| National Cancer Institute (NCI) | Early Phase 1 |
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: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Cephalon | TRISENOX | arsenic trioxide | INJECTABLE;INJECTION | 021248-002 | Oct 13, 2017 | AP | RX | Yes | Yes | ⤷ 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 TRISENOX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| 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 | 021248-001 | 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 |
| >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 |
|---|---|---|---|
| Japan | 2010184926 | METHOD FOR PRODUCING ARSENIC TRIOXIDE FORMULATION AND METHOD OF TREATING CANCER USING ARSENIC TRIOXIDE OR MELARSOPROL | ⤷ Sign Up |
| European Patent Office | 1964557 | Procédé de production de formulations à base de trioxide d'arsenic (Process for producing arsenic trioxide formulations) | ⤷ Sign Up |
| Australia | 1397399 | ⤷ Sign Up | |
| Indonesia | 25622 | ⤷ Sign Up | |
| Turkey | 200002243 | ⤷ Sign Up | |
| Portugal | 2255800 | ⤷ Sign Up | |
| Spain | 2399480 | ⤷ Sign Up | |
| >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.
ISSN: 2162-2639
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