➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim

Last Updated: June 14, 2021

DrugPatentWatch Database Preview

BELEODAQ Drug Profile

Email this page to a colleague

« Back to Dashboard

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. 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

< Available with Subscription >

  Get Started Free

Drug patent expirations by year for BELEODAQ
Drug Prices for BELEODAQ

See drug prices for BELEODAQ

DrugPatentWatch® Estimated Generic Entry Opportunity Date for BELEODAQ
Generic Entry Date for BELEODAQ*:
Constraining patent/regulatory exclusivity:

*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

Axis Clinicals LimitedPhase 1
Acrotech Biopharma LLCPhase 1
Mayo ClinicPhase 1

See all BELEODAQ clinical trials

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

US Patents and Regulatory Information for BELEODAQ

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 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
Johnson and Johnson
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.