Arsenic Trioxide Patent Expiration
Arsenic Trioxide is Used for treating acute promyelocytic leukemia (APL) characterized by specific genetic markers and resistance to traditional chemotherapy. It was first introduced by Cephalon Inc
Arsenic Trioxide Patents
Given below is the list of patents protecting Arsenic Trioxide, along with the drug name that holds that patent and the company name owning that drug.
| Drug Used in | Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Drug Owner |
|---|---|---|---|---|
| Trisenox | US6723351 | Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol |
Nov 10, 2018
(Expired) | Cephalon |
| Trisenox | US6855339 | Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol |
Nov 10, 2018
(Expired) | Cephalon |
| Trisenox | US6861076 | Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol |
Nov 10, 2018
(Expired) | Cephalon |
| Trisenox | US6884439 | Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol |
Nov 10, 2018
(Expired) | Cephalon |
| Trisenox | US6982096 | Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol |
Nov 10, 2018
(Expired) | Cephalon |
| Trisenox | US8273379 | Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol |
Nov 10, 2018
(Expired) | Cephalon |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Arsenic Trioxide's patents.
Latest Legal Activities on Arsenic Trioxide's Patents
Given below is the list recent legal activities going on the following patents of Arsenic Trioxide.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 02 Nov, 2020 | US8273379 |
| Maintenance Fee Reminder Mailed Critical | 18 May, 2020 | US8273379 |
| Patent Issue Date Used in PTA Calculation Critical | 25 Sep, 2012 | US8273379 |
| Recordation of Patent Grant Mailed Critical | 25 Sep, 2012 | US8273379 |
| Email Notification Critical | 06 Sep, 2012 | US8273379 |
| Issue Notification Mailed Critical | 05 Sep, 2012 | US8273379 |
| Dispatch to FDC | 29 Aug, 2012 | US8273379 |
| Application Is Considered Ready for Issue Critical | 28 Aug, 2012 | US8273379 |
| Issue Fee Payment Received Critical | 27 Aug, 2012 | US8273379 |
| Issue Fee Payment Verified Critical | 27 Aug, 2012 | US8273379 |
Arsenic Trioxide's Family Patents
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Arsenic Trioxide Generic API Manufacturers
Several generic applications have been filed for Arsenic Trioxide. The first generic version for Arsenic Trioxide was by Fresenius Kabi Usa Llc and was approved on Aug 31, 2018. And the latest generic version is by Orbicular Pharmaceutical Technologies Private Ltd and was approved on Apr 20, 2023.
Given below is the list of companies who have filed for Arsenic Trioxide generic, along with the locations of their manufacturing plants worldwide.
1. AMNEAL
Amneal Eu Ltd has filed for 2 different strengths of generic version for Arsenic Trioxide. Given below are the details of the strengths of this generic introduced by Amneal.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1MG/ML | injectable | Prescription | INJECTION | AP | Jan 25, 2021 |
| 2MG/ML | injectable | Prescription | INJECTION | AP | Aug 19, 2021 |
Manufacturing Plant Locations New
Amneal's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Amneal as present at those locations.
| Country | City | Firm Name | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United States |
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| India |
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2. AMRING PHARMS
Amring Pharmaceuticals Inc has filed for 1 generic for Arsenic Trioxide. Given below are the details of the strengths of this generic introduced by Amring Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1MG/ML | injectable | Prescription | INJECTION | AP | Nov 13, 2018 |
3. EUGIA PHARMA
Eugia Pharma Specialities Ltd has filed for 1 generic for Arsenic Trioxide. Given below are the details of the strengths of this generic introduced by Eugia Pharma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 2MG/ML | injectable | Discontinued | INJECTION | N/A | Oct 15, 2021 |
Manufacturing Plant Locations New
Eugia Pharma's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Eugia Pharma as present at those locations.
| Country | City | Firm Name | ||||||
|---|---|---|---|---|---|---|---|---|
| India |
| |||||||
4. FRESENIUS KABI USA
Fresenius Kabi Usa Llc has filed for 1 generic for Arsenic Trioxide. Given below are the details of the strengths of this generic introduced by Fresenius Kabi Usa.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1MG/ML
(reference standard) | injectable | Prescription | INJECTION | AP | Aug 31, 2018 |
Manufacturing Plant Locations New
Fresenius Kabi Usa's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Fresenius Kabi Usa as present at those locations.
| Country | City | Firm Name | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United States |
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5. GLAND
Gland Pharma Ltd has filed for 2 different strengths of generic version for Arsenic Trioxide. Given below are the details of the strengths of this generic introduced by Gland.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 2MG/ML | injectable | Prescription | INJECTION | AP | Oct 7, 2021 |
| 1MG/ML | injectable | Prescription | INJECTION | AP | Apr 22, 2022 |
Manufacturing Plant Locations New
Gland's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Gland as present at those locations.
| Country | City | Firm Name | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| India |
| |||||||||||||||
6. INGENUS PHARMS LLC
Ingenus Pharmaceuticals Llc has filed for 2 different strengths of generic version for Arsenic Trioxide. Given below are the details of the strengths of this generic introduced by Ingenus Pharms Llc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1MG/ML | injectable | Prescription | INJECTION | AP | Nov 15, 2018 |
| 2MG/ML | injectable | Discontinued | INJECTION | N/A | Jan 14, 2021 |
7. NEXUS
Nexus Pharmaceuticals Llc has filed for 1 generic for Arsenic Trioxide. Given below are the details of the strengths of this generic introduced by Nexus.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1MG/ML | injectable | Prescription | INJECTION | AP | Nov 15, 2018 |
Manufacturing Plant Locations New
Nexus's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Nexus as present at those locations.
| Country | City | Firm Name | ||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United States |
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8. ORBICULAR
Orbicular Pharmaceutical Technologies Private Ltd has filed for 2 different strengths of generic version for Arsenic Trioxide. Given below are the details of the strengths of this generic introduced by Orbicular.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1MG/ML | injectable | Prescription | INJECTION | AP | Apr 20, 2023 |
| 2MG/ML | injectable | Prescription | INJECTION | AP | Apr 20, 2023 |
9. PENN LIFE
Penn Life Sciences Llc has filed for 1 generic for Arsenic Trioxide. Given below are the details of the strengths of this generic introduced by Penn Life.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1MG/ML | injectable | Prescription | INJECTION | AP | May 6, 2019 |
10. SANDOZ
Sandoz Inc has filed for 1 generic for Arsenic Trioxide. Given below are the details of the strengths of this generic introduced by Sandoz.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 2MG/ML | injectable | Prescription | INJECTION | AP | Dec 2, 2021 |
Manufacturing Plant Locations New
Sandoz's manufacturing plants are situated in 4 countries - Austria, United States, Spain, India. Given below are the details of these plant locations as well as the firm names of Sandoz as present at those locations.
| Country | City | Firm Name | ||||
|---|---|---|---|---|---|---|
| Austria |
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| United States |
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| Spain |
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| India |
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11. ZYDUS PHARMS
Zydus Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Arsenic Trioxide. Given below are the details of the strengths of this generic introduced by Zydus Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1MG/ML | injectable | Prescription | INJECTION | AP | Nov 13, 2018 |
| 2MG/ML | injectable | Prescription | INJECTION | AP | Aug 30, 2019 |