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Last Updated: August 11, 2020

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TRISENOX Drug 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. 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 Trisenox

A generic version of TRISENOX was approved as arsenic trioxide by FRESENIUS KABI USA on August 31st, 2018.

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Drug patent expirations by year for TRISENOX
Drug Prices for TRISENOX

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Recent Clinical Trials for TRISENOX

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SponsorPhase
Orsenix LLCPhase 1
FoveaPhase 2
MedsenicPhase 2

See all TRISENOX clinical trials

Paragraph IV (Patent) Challenges for TRISENOX
Tradename Dosage Ingredient NDA Submissiondate
TRISENOX INJECTABLE;INJECTION arsenic trioxide 021248 2015-08-11

US Patents and Regulatory Information for TRISENOX

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   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 TRISENOX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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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