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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Federal Trade Commission
AstraZeneca
Cipla
Boehringer Ingelheim
Cerilliant
Accenture
Farmers Insurance
US Army

Generated: July 19, 2018

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 arsenic trioxide patent protection?

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

Arsenic trioxide has twenty-seven patent family members in nineteen countries.

There are five drug master file entries for arsenic trioxide. One supplier is listed for this compound. There is one tentative approval for this compound.
Tentative approvals for ARSENIC TRIOXIDE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up10MLINJECTABLE; 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 021248-002 Oct 13, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Cephalon TRISENOX arsenic trioxide INJECTABLE;INJECTION 021248-002 Oct 13, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Cephalon TRISENOX arsenic trioxide INJECTABLE;INJECTION 021248-001 Sep 25, 2000 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Cephalon TRISENOX arsenic trioxide INJECTABLE;INJECTION 021248-002 Oct 13, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
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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Non-Orange Book US Patents for arsenic trioxide

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,770,304 Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol ➤ Sign Up
7,879,364 Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Baxter
Medtronic
Queensland Health
Deloitte
Cerilliant
Teva
Fuji
Cantor Fitzgerald

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.