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Last Updated: September 18, 2020

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ARSENIC TRIOXIDE Drug 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 Amring Pharms, Fresenius Kabi Usa, Ingenus Pharms Llc, Nexus Pharms, Sti Pharma Llc, and Zydus Pharms. and is included in six NDAs.

The generic ingredient in ARSENIC TRIOXIDE is arsenic trioxide. There are five drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the arsenic trioxide profile page.

US ANDA 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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Drug patent expirations by year for ARSENIC TRIOXIDE
Drug Prices for ARSENIC TRIOXIDE

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Recent Clinical Trials for ARSENIC TRIOXIDE

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SponsorPhase
Ruijin HospitalN/A
Ministry of Science and Technology of the People´s Republic of ChinaPhase 3
Guangzhou 8th People's HospitalPhase 1

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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
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
Fresenius Kabi Usa ARSENIC TRIOXIDE arsenic trioxide INJECTABLE;INJECTION 208231-001 Aug 31, 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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