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Last Updated: August 4, 2020

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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 Amring Pharms, Fresenius Kabi Usa, Ingenus Pharms Llc, Nexus Pharms, Sti Pharma Llc, Zydus Pharms, and Cephalon, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for arsenic trioxide. Eight suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for arsenic trioxide

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Recent Clinical Trials for arsenic trioxide

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Ministry of Science and Technology of the People´s Republic of ChinaPhase 3
Guangzhou Institutes of Biomedicine and Health Chinese Academy of SciencesPhase 1
Guangzhou 8th People's HospitalPhase 1

See all arsenic trioxide clinical trials

Generic filers with tentative approvals for ARSENIC TRIOXIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial10MLINJECTABLE; INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Paragraph IV (Patent) Challenges for ARSENIC TRIOXIDE
Tradename Dosage Ingredient NDA Submissiondate
TRISENOX INJECTABLE;INJECTION arsenic trioxide 021248 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
Zydus Pharms ARSENIC TRIOXIDE arsenic trioxide INJECTABLE;INJECTION 206228-001 Nov 13, 2018 AP RX No No   Start Trial   Start Trial   Start Trial
Sti Pharma Llc ARSENIC TRIOXIDE arsenic trioxide INJECTABLE;INJECTION 209873-001 May 6, 2019 AP RX No No   Start Trial   Start Trial   Start Trial
Amring Pharms ARSENIC TRIOXIDE arsenic trioxide INJECTABLE;INJECTION 210802-001 Nov 13, 2018 AP RX No No   Start Trial   Start Trial   Start Trial
Zydus Pharms ARSENIC TRIOXIDE arsenic trioxide INJECTABLE;INJECTION 206228-002 Aug 30, 2019 AP RX No No   Start Trial   Start Trial   Start Trial
Nexus Pharms ARSENIC TRIOXIDE arsenic trioxide INJECTABLE;INJECTION 209780-001 Nov 15, 2018 AP RX No No   Start Trial   Start Trial   Start Trial
Ingenus Pharms Llc ARSENIC TRIOXIDE arsenic trioxide INJECTABLE;INJECTION 209315-001 Nov 15, 2018 AP RX No No   Start Trial   Start Trial   Start Trial
Cephalon TRISENOX arsenic trioxide INJECTABLE;INJECTION 021248-002 Oct 13, 2017 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
>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 021248-002 Oct 13, 2017   Start Trial   Start Trial
Cephalon TRISENOX arsenic trioxide INJECTABLE;INJECTION 021248-001 Sep 25, 2000   Start Trial   Start Trial
Cephalon TRISENOX arsenic trioxide INJECTABLE;INJECTION 021248-001 Sep 25, 2000   Start Trial   Start Trial
Cephalon TRISENOX arsenic trioxide INJECTABLE;INJECTION 021248-001 Sep 25, 2000   Start Trial   Start Trial
Cephalon TRISENOX arsenic trioxide INJECTABLE;INJECTION 021248-001 Sep 25, 2000   Start Trial   Start Trial
Cephalon TRISENOX arsenic trioxide INJECTABLE;INJECTION 021248-002 Oct 13, 2017   Start Trial   Start Trial
Cephalon TRISENOX arsenic trioxide INJECTABLE;INJECTION 021248-002 Oct 13, 2017   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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