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Last Updated: August 12, 2020

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BELEODAQ Drug 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.

US ANDA Litigation and 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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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
Axis Clinicals LimitedPhase 1
Acrotech Biopharma LLCPhase 1
Mayo ClinicPhase 1

See all BELEODAQ clinical trials

Pharmacology for BELEODAQ
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   Start Trial   Start Trial Y Y   Start Trial
Acrotech BELEODAQ belinostat POWDER;INTRAVENOUS 206256-001 Jul 3, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Acrotech BELEODAQ belinostat POWDER;INTRAVENOUS 206256-001 Jul 3, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
>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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Serving leading biopharmaceutical companies globally:

Express Scripts
Johnson and Johnson
Baxter
Medtronic
Merck
Boehringer Ingelheim

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