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Last Updated: February 27, 2020

DrugPatentWatch Database Preview

BELEODAQ Drug Profile


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Which patents cover Beleodaq, 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. Two suppliers are 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

Recent Litigation for BELEODAQ

Identify potential future generic entrants

District Court Litigation
Case NameDate
Acrotech Biopharma, LLC v. Fresenius Kabi USA, LLC2018-10-03

See all BELEODAQ litigation

Pharmacology for BELEODAQ
Synonyms for BELEODAQ
(2E)-N-hydroxy-3-[3-(phenylsulfamoyl)phenyl]acrylamide
(2E)-N-hydroxy-3-[3-(phenylsulfamoyl)phenyl]prop-2-enamide
(E)-3-[3-(phenylsulfamoyl)phenyl]prop-2-enehydroxamic acid
(E)-N-hydroxy-3-(3-(N-phenylsulfamoyl)phenyl)acrylamide
(E)-N-Hydroxy-3-(3-phenylsulfamoyl-phenyl)-acrylamide
(E)-N-hydroxy-3-[3-(phenylsulfamoyl)phenyl]prop-2-enamide
2-Propenamide, N-hydroxy-3-(3-((phenylamino)sulfonyl)phenyl)-, (2E)-
2-Propenamide, N-hydroxy-3-[3-[(phenylamino)sulfonyl]phenyl]-, (2E)-
414864-00-9
5OG
866323-14-0
A25012
AB0007889
ABP000140
AC-25046
AC1OCFO7
AK544325
AK546422
AKOS025401741
AN-1073
AOB87787
API0003555
AS-17068
AX8144528
BC251660
BCP01741
BCP9000386
BCPP000351
BDBM25150
Beleodaq (TN)
Belinostat
Belinostat (PXD101)
Belinostat - PXD101
Belinostat (PXD101)
Belinostat (USAN/INN)
Belinostat [USAN:INN]
Belinostat Ph3
Belinostat,PXD101, PX105684
Belinostat(Random Configuration)
Belinostat/PXD101,PX105684/
BRD-K17743125-001-01-9
CCG-208758
CHEBI:61076
CHEBI:94531
CHEMBL408513
D08870
DB05015
DTXSID60194378
E-Belinostat
EX-A180
F4H96P17NZ
GTPL7496
J-523584
KB-74881
LS41098
MLS006011091
MolPort-009-679-433
N-Hydroxy-3-(3-(N-phenylsulfamoyl)phenyl)acrylamide
N-hydroxy-3-(3-(phenylsulfamoyl)phenyl)prop-2-enamide
N-hydroxy-3-(3-phenylsulfamoyl-phenyl)-acrylamide
N-HYDROXY-3-(3-PHENYLSULFAMOYLPHENYL)ACRYLAMIDE
N-Hydroxy-3-(3-phenylsulphamoylphenyl)acrylamide
N-Hydroxy-3-[(phenylamino)sulfonyl]-trans-cinnamamide
N-hydroxy-3-[3-(phenylsulfamoyl)phenyl]-2-propenamide
N-HYDROXY-3-[3-[(PHENYLAMINO)SULFONYL]PHENYL]-2-PR
N-HYDROXY-3-[3-[(PHENYLAMINO)SULFONYL]PHENYL]-2-PROPENAMIDE
NCGC00263155-05
NCNRHFGMJRPRSK-MDZDMXLPSA-N
NSC-726630
NSC726630
PubChem22405
PX 105684
PX-105684
PX105684
PX105684, 414864-00-9
PXD 101
PXD-101
PXD101
QCR-181
RL03602
RT-014445
s1085
SB16466
SC-71101
SMR004702879
SW219445-1
UNII-F4H96P17NZ
W-5363
ZINC3818726
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   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:

Baxter
AstraZeneca
McKinsey
Boehringer Ingelheim
Express Scripts
Mallinckrodt

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 verifification 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.