BELINOSTAT - Generic Drug Details
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What are the generic drug sources for belinostat and what is the scope of patent protection?
Belinostat
is the generic ingredient in one branded drug marketed by Acrotech Biopharma 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. One supplier is listed for this compound.
Summary for BELINOSTAT
International Patents: | 59 |
US Patents: | 2 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 5 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 122 |
Clinical Trials: | 54 |
Patent Applications: | 4,907 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BELINOSTAT |
What excipients (inactive ingredients) are in BELINOSTAT? | BELINOSTAT excipients list |
DailyMed Link: | BELINOSTAT at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for BELINOSTAT
Generic Entry Date for BELINOSTAT*:
Constraining patent/regulatory exclusivity:
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 BELINOSTAT
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
H. Lee Moffitt Cancer Center and Research Institute | Phase 2 |
Pfizer | Phase 2 |
Acrotech Biopharma | Phase 2 |
Pharmacology for BELINOSTAT
Drug Class | Histone Deacetylase Inhibitor |
Mechanism of Action | Histone Deacetylase Inhibitors |
Paragraph IV (Patent) Challenges for BELINOSTAT
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
BELEODAQ | Injection | belinostat | 500 mg/vial | 206256 | 1 | 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 Biopharma | BELEODAQ | belinostat | POWDER;INTRAVENOUS | 206256-001 | Jul 3, 2014 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Acrotech Biopharma | BELEODAQ | belinostat | POWDER;INTRAVENOUS | 206256-001 | Jul 3, 2014 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a 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 | Title | Estimated Expiration |
---|---|---|---|
Canada | 2606598 | FORMULATIONS PHARMACEUTIQUES D'INHIBITEURS DE HDAC (PHARMACEUTICAL FORMULATIONS OF HDAC INHIBITORS) | ⤷ Try a Trial |
China | 101189003 | Pharmaceutical formulations of HDAC inhibitors | ⤷ Try a Trial |
South Korea | 101340824 | ⤷ Try a Trial | |
European Patent Office | 1328510 | COMPOSÉS (E)-N-HYDROXY-3-(3-SULFAMOYL-PHENYL)-ACRYLAMIDE ET LEUR UTILISATION THÉRAPEUTIQUE ((E)-N-HYDROXY-3-(3-SULFAMOYL-PHENYL)-ACRYLAMIDE COMPOUNDS AND THEIR THERAPEUTIC USE) | ⤷ Try a Trial |
Japan | 2012188444 | PHARMACEUTICAL FORMULATION OF HDAC INHIBITOR | ⤷ Try a Trial |
Brazil | PI0610128 | composição farmacêutica, bolsa de infusão intravenosa, frasco ou ampola, kit, usos de um inibidor de hdac e um ou mais de ciclodextrina, arginina e meglumina e de uma composição, e, métodos de regular a proliferação celular, inibir à progressão do ciclo celular, promover a apoptose, ou uma combinação de um ou mais destes, in vitro ou in vivo, de tratamento de uma condição mediada pela hdac, de tratamento de uma condição proliferativa e de tratamento de cáncer | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
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