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Generated: September 26, 2018

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Arsenic trioxide - Generic Drug Details

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What are the generic drug sources for arsenic trioxide and what is the scope of arsenic trioxide freedom to operate?

Arsenic trioxide is the generic ingredient in two branded drugs marketed by Fresenius Kabi Usa and Cephalon, and is included in two NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

Tentative approvals for ARSENIC TRIOXIDE
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial10MLINJECTABLE; INJECTION

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 021248-001 Sep 25, 2000 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Cephalon TRISENOX arsenic trioxide INJECTABLE;INJECTION 021248-002 Oct 13, 2017 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Cephalon TRISENOX arsenic trioxide INJECTABLE;INJECTION 021248-001 Sep 25, 2000 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Cephalon TRISENOX arsenic trioxide INJECTABLE;INJECTION 021248-001 Sep 25, 2000 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free 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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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Queensland Health
Mallinckrodt
Fuji
Colorcon
McKesson
Boehringer Ingelheim
Healthtrust
Moodys

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