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Serving leading biopharmaceutical companies globally:

AstraZeneca
US Army
Covington
Argus Health
Novartis
Federal Trade Commission
Moodys
Teva
Accenture
Johnson and Johnson

Generated: November 17, 2017

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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-six patent family members in eighteen 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
u► Subscribe10MLINJECTABLE; INJECTION
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;INJECTION021248-001Sep 25, 2000RXYesYes► Subscribe► Subscribe ► Subscribe
Cephalon
TRISENOX
arsenic trioxide
INJECTABLE;INJECTION021248-001Sep 25, 2000RXYesYes► Subscribe► Subscribe ► Subscribe
Cephalon
TRISENOX
arsenic trioxide
INJECTABLE;INJECTION021248-001Sep 25, 2000RXYesYes► Subscribe► Subscribe ► Subscribe
Cephalon
TRISENOX
arsenic trioxide
INJECTABLE;INJECTION021248-001Sep 25, 2000RXYesYes► Subscribe► Subscribe ► Subscribe
Cephalon
TRISENOX
arsenic trioxide
INJECTABLE;INJECTION021248-001Sep 25, 2000RXYesYes► Subscribe► Subscribe ► Subscribe
Cephalon
TRISENOX
arsenic trioxide
INJECTABLE;INJECTION021248-001Sep 25, 2000RXYesYes► Subscribe► Subscribe ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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► Subscribe
7,879,364Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: arsenic trioxide

Country Document Number Estimated Expiration
Cyprus1113856► Subscribe
World Intellectual Property Organization (WIPO)9924029► Subscribe
Turkey200002243► Subscribe
Hong Kong1150762► Subscribe
Brazil9814857► Subscribe
Japan2010184926► Subscribe
Australia1397399► Subscribe
Denmark1964557► Subscribe
European Patent Office2255800► Subscribe
European Patent Office1037625► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Serving leading biopharmaceutical companies globally:

Cipla
US Army
McKinsey
Dow
UBS
Merck
Federal Trade Commission
Citi
Medtronic
McKesson

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.

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