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Belinostat - Generic Drug Details
What are the generic sources for belinostat and what is the scope of patent protection?
Belinostat
is the generic ingredient in one branded drug marketed by Acrotech and is included in one NDA. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Belinostat has fifty-nine patent family members in twenty-seven countries.
There are five drug master file entries for belinostat. Two suppliers are listed for this compound.
Summary for belinostat
| International Patents: | 59 |
| US Patents: | 2 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 5 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 87 |
| Clinical Trials: | 44 |
| Patent Applications: | 19 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for belinostat |
| DailyMed Link: | belinostat at DailyMed |
Recent Clinical Trials for belinostat
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Celgene | Phase 3 |
| The Lymphoma Academic Research Organisation | Phase 3 |
| Mayo Clinic | Phase 1 |
Recent Litigation for belinostat
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Spectrum Pharmaceuticals, Inc. v. Fresenius Kabi USA, LLC | 2018-10-03 |
Pharmacology for belinostat
| Drug Class | Histone Deacetylase Inhibitor |
| Mechanism of Action | Histone Deacetylase Inhibitors |
Synonyms for belinostat
| (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 |
| Beleodaq (TN) |
| 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 BELINOSTAT
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| BELEODAQ | POWDER;INTRAVENOUS | belinostat | 206256 | 2018-07-03 |
US Patents and Regulatory Information for belinostat
| 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 | Start Trial | ||||
| >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 belinostat
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 4976354 | Start Trial |
| South Africa | 200710313 | Start Trial |
| World Intellectual Property Organization (WIPO) | 0230879 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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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.
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.