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Serving hundreds of leading biopharmaceutical companies globally:

Covington
McKinsey
Federal Trade Commission
QuintilesIMS
Teva
Farmers Insurance
Cipla
Citi
UBS

Generated: August 18, 2018

DrugPatentWatch Database Preview

TRISENOX Drug Profile

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Which patents cover Trisenox, and when can generic versions of Trisenox launch?

Trisenox is a drug marketed by Cephalon and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-seven patent family members in nineteen countries.

The generic ingredient in TRISENOX is arsenic trioxide. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the arsenic trioxide profile page.

Drug patent expirations by year for TRISENOX
Generic Entry Opportunity Date for TRISENOX
Generic Entry Date for TRISENOX*:
Constraining patent/regulatory exclusivity:
ARSENIC TRIOXIDE FOR USE IN COMBINATION WITH TRETINOIN FOR TREATMENT OF ADULTS WITH NEWLY-DIAGNOSED LOW-RISK ACUTE PROMYELOCYTIC LEUKEMIA (APL) WHOSE APL IS CHARACTERIZED BY THE PRESENCE OF THE T(15;17) TRANSLOCATION OR PML/RAR-ALPHA GENE EXPRESSION
NDA:
Dosage:
INJECTABLE;INJECTION

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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 021248-002 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 DISCN Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Cephalon TRISENOX arsenic trioxide INJECTABLE;INJECTION 021248-001 Sep 25, 2000 DISCN Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Cephalon TRISENOX arsenic trioxide INJECTABLE;INJECTION 021248-001 Sep 25, 2000 DISCN Yes No ➤ 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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Paragraph IV (Patent) Challenges for TRISENOX
Drugname Dosage Strength RLD Date
➤ Subscribe Injection 1 mg/mL ➤ Subscribe ➤ Sign Up

Non-Orange Book US Patents for TRISENOX

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:

Healthtrust
Chinese Patent Office
US Department of Justice
QuintilesIMS
Deloitte
Citi
Federal Trade Commission
Mallinckrodt
Medtronic

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