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Last Updated: November 12, 2019

DrugPatentWatch Database Preview

Arsenic trioxide - Generic Drug Details

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What are the generic sources for arsenic trioxide and what is the scope of patent protection?

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.

Recent Clinical Trials for arsenic trioxide

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SponsorPhase
Guangzhou 8th People's HospitalPhase 1
Guangzhou Institutes of Biomedicine and Health Chinese Academy of SciencesPhase 1
Yang LiPhase 2

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Recent Litigation for arsenic trioxide

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District Court Litigation
Case NameDate
Cephalon, Inc. v. Fresenius Kabi USA, LLC2015-11-19

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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
Cephalon TRISENOX arsenic trioxide INJECTABLE;INJECTION 021248-002 Oct 13, 2017 AP RX Yes Yes   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
Zydus Pharms ARSENIC TRIOXIDE arsenic trioxide INJECTABLE;INJECTION 206228-002 Aug 30, 2019 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
Fresenius Kabi Usa ARSENIC TRIOXIDE arsenic trioxide INJECTABLE;INJECTION 208231-001 Aug 31, 2018 AP RX No No   Start Trial   Start Trial   Start Trial
Zydus Pharms ARSENIC TRIOXIDE arsenic trioxide INJECTABLE;INJECTION 206228-001 Nov 13, 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

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 021248-002 Oct 13, 2017   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 021248-001 Sep 25, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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 verifification 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.