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Last Updated: June 15, 2021

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Belinostat - Generic Drug Details

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

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

Belinostat has fifty-nine patent family members in twenty-seven countries.

There are five drug master file entries for belinostat.

Summary for belinostat
International Patents:59
US Patents:2
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 5
Raw Ingredient (Bulk) Api Vendors: 103
Clinical Trials: 51
Patent Applications: 5,430
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for belinostat
What excipients (inactive ingredients) are in belinostat?belinostat excipients list
DailyMed Link:belinostat at DailyMed
Recent Clinical Trials for belinostat

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
CelgenePhase 2
Food and Drug Administration (FDA)Phase 2
University of VirginiaPhase 2

See all belinostat clinical trials

Paragraph IV (Patent) Challenges for BELINOSTAT
Tradename Dosage Ingredient NDA Submissiondate
BELEODAQ POWDER;INTRAVENOUS belinostat 206256 2018-07-03

US Patents and Regulatory Information for belinostat

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Acrotech BELEODAQ belinostat POWDER;INTRAVENOUS 206256-001 Jul 3, 2014 RX Yes Yes   Get Started Free   Get Started Free Y Y   Get Started Free
Acrotech BELEODAQ belinostat POWDER;INTRAVENOUS 206256-001 Jul 3, 2014 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Acrotech BELEODAQ belinostat POWDER;INTRAVENOUS 206256-001 Jul 3, 2014 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for belinostat

Country Patent Number Estimated Expiration
Serbia 52214   Get Started Free
European Patent Office 1328510   Get Started Free
World Intellectual Property Organization (WIPO) 2006120456   Get Started Free
South Korea 20130079665   Get Started Free
New Zealand 563236   Get Started Free
Japan 2012188444   Get Started Free
Cyprus 1112498   Get Started Free
>Country >Patent Number >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Moodys
Express Scripts
Baxter
Merck
Dow
Boehringer Ingelheim

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