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Last Updated: August 17, 2022

BELEODAQ Drug Patent Profile


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When do Beleodaq patents expire, and when can generic versions of Beleodaq launch?

Beleodaq is a drug marketed by Acrotech and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

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

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

DrugPatentWatch® Generic Entry Outlook for Beleodaq

Beleodaq was eligible for patent challenges on July 3, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 27, 2027. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for BELEODAQ
Drug Prices for BELEODAQ

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DrugPatentWatch® Estimated Generic Entry Opportunity Date for BELEODAQ
Generic Entry Date for BELEODAQ*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
POWDER;INTRAVENOUS

*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.

Recent Clinical Trials for BELEODAQ

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

SponsorPhase
University of UtahPhase 1
Mayo ClinicPhase 1
Axis Clinicals LimitedPhase 1

See all BELEODAQ clinical trials

Pharmacology for BELEODAQ
Paragraph IV (Patent) Challenges for BELEODAQ
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 BELEODAQ

BELEODAQ is protected by two US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of BELEODAQ is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting BELEODAQ

Carbamic acid compounds comprising a sulfonamide linkage as HDAC inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY PERIPHERAL T-CELL LYMPHOMA (PTCL).

Pharmaceutical formulations of HDAC inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: 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
Acrotech 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 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 BELEODAQ

When does loss-of-exclusivity occur for BELEODAQ?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 06245495
Estimated Expiration: See Plans and Pricing

Austria

Patent: 2527
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0610128
Estimated Expiration: See Plans and Pricing

Canada

Patent: 06598
Estimated Expiration: See Plans and Pricing

China

Patent: 1189003
Estimated Expiration: See Plans and Pricing

Patent: 2579417
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0120341
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 12498
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 01729
Estimated Expiration: See Plans and Pricing

Patent: 94969
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 078002
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 8982
Estimated Expiration: See Plans and Pricing

Patent: 3400
Estimated Expiration: See Plans and Pricing

Patent: 0702467
Estimated Expiration: See Plans and Pricing

Patent: 1370122
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 01729
Estimated Expiration: See Plans and Pricing

Patent: 94969
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 10797
Estimated Expiration: See Plans and Pricing

Israel

Patent: 7231
Estimated Expiration: See Plans and Pricing

Patent: 4229
Estimated Expiration: See Plans and Pricing

Japan

Patent: 08750
Estimated Expiration: See Plans and Pricing

Patent: 67068
Estimated Expiration: See Plans and Pricing

Patent: 08540499
Estimated Expiration: See Plans and Pricing

Patent: 12188444
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 07013938
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 3236
Estimated Expiration: See Plans and Pricing

Norway

Patent: 9954
Estimated Expiration: See Plans and Pricing

Patent: 076366
Estimated Expiration: See Plans and Pricing

Poland

Patent: 01729
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 01729
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 214
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 01729
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0710313
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1329437
Estimated Expiration: See Plans and Pricing

Patent: 1340824
Estimated Expiration: See Plans and Pricing

Patent: 080016636
Estimated Expiration: See Plans and Pricing

Patent: 130079665
Estimated Expiration: See Plans and Pricing

Spain

Patent: 80887
Estimated Expiration: See Plans and Pricing

Patent: 40204
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 810
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering BELEODAQ around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 1328510 COMPOSÉS (E)-N-HYDROXY-3-(3-SULFAMOYL-PHENYL)-ACRYLAMIDE ET LEUR UTILISATION THÉRAPEUTIQUE ((E)-N-HYDROXY-3-(3-SULFAMOYL-PHENYL)-ACRYLAMIDE COMPOUNDS AND THEIR THERAPEUTIC USE) See Plans and Pricing
New Zealand 525439 Carbamic acid compounds comprising a sulfonamide linkage as HDAC inhibitors See Plans and Pricing
World Intellectual Property Organization (WIPO) 0230879 See Plans and Pricing
Croatia P20120341 See Plans and Pricing
New Zealand 535065 Carbamic acid compounds comprising a sulfonamide linkage as HDAC inhibitors See Plans and Pricing
Australia 2001290131 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Express Scripts
Johnson and Johnson
Baxter
Medtronic
Merck
Boehringer Ingelheim

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.