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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.
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
Summary for BELEODAQ
|Suppliers / Packagers:||1|
|Bulk Api Vendors:||94|
|Drug Prices:||Drug price information for BELEODAQ|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for BELEODAQ|
|DailyMed Link:||BELEODAQ at DailyMed|
Generic Entry Opportunity Date for BELEODAQ
*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 Limited||Phase 1|
|Acrotech Biopharma LLC||Phase 1|
|Mayo Clinic||Phase 1|
|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|
|Country||Patent Number||Estimated Expiration|
|World Intellectual Property Organization (WIPO)||0230879||Start Trial|
|South Korea||20130079665||Start Trial|
|>Country||>Patent Number||>Estimated Expiration|