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Last Updated: December 8, 2022

Belinostat - Generic Drug Details

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What are the generic sources for belinostat and what is the scope of patent protection?

Belinostat is the generic ingredient in one branded drug marketed by Acrotech Biopharma 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
Drug Master File Entries: 5
Raw Ingredient (Bulk) Api Vendors: 115
Clinical Trials: 53
Patent Applications: 6,773
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

PfizerPhase 2
Acrotech BiopharmaPhase 2
H. Lee Moffitt Cancer Center and Research InstitutePhase 2

See all belinostat clinical trials

Pharmacology for belinostat
Paragraph IV (Patent) Challenges for BELINOSTAT
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
BELEODAQ Injection belinostat 500 mg/vial 206256 1 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 Biopharma BELEODAQ belinostat POWDER;INTRAVENOUS 206256-001 Jul 3, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Acrotech Biopharma BELEODAQ belinostat POWDER;INTRAVENOUS 206256-001 Jul 3, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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 Title Estimated Expiration
Denmark 1901729 See Plans and Pricing
South Korea 101340824 See Plans and Pricing
Cyprus 1112498 See Plans and Pricing
Australia 9013101 See Plans and Pricing
South Korea 101329437 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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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 verification 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.