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Generic Beleodaq Availability

Beleodaq is a brand name of belinostat, approved by the FDA in the following formulation(s):

BELEODAQ (belinostat - powder;iv (infusion))

  • Manufacturer: SPECTRUM PHARMS
    Approval date: July 3, 2014
    Strength(s): 500MG/VIAL [RLD]

Has a generic version of Beleodaq been approved?

No. There is currently no therapeutically equivalent version of Beleodaq available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Beleodaq. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

  • Carbamic acid compounds comprising a sulfonamide linkage as HDAC inhibitors
    Patent 6,888,027
    Issued: May 3, 2005
    Inventor(s): Watkins; Clare J & Romero-Martin; Maria Rosario & Moore; Kathryn G & Ritchie; James & Finn; Paul W & Kalvinsh; Ivars & Loza; Einars & Dikovska; Klara & Gailite; Vija & Vorona; Maxim & Piskunova; Irina & Starchenkov; Igor & Andrianov; Victor & Harris; C. John & Duffy; James E. S.
    Assignee(s): Topotarget UK Limited
    This invention pertains to certain active carbamic acid compounds which inhibit HDAC activity and which have the following formula: (I) A is an aryl group; Q1 is a covalent bond or an aryl leader group; J is a sulfonamide linkage selected from: —S(═O)2NR1— and —NR1S(═O)2—; R1 is a sulfonamido substituent; and, Q2 is an acid leader group; with the proviso that if J is —S(═O)2NR1—, then Q1 is an aryl leader group; and pharmaceutically acceptable salts, solvates, amides, esters, ethers, chemically protected forms, and prodrugs thereof. The present invention also pertains to pharmaceutical compositions comprising such compounds, and the use of such compounds and compositions, both in vitro and in vivo, to inhibit HDAC, and, e.g., to inhibit proliferative conditions, such as cancer and psoriasis.
    Patent expiration dates:
    • September 27, 2021
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      Patent use: TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY PERIPHERAL T-CELL LYMPHOMA (PTCL).
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      Drug substance
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      Drug product
  • Pharmaceutical formulations of HDAC inhibitors
    Patent 8,835,501
    Issued: September 16, 2014
    Assignee(s): TopoTarget UK Limited
    This invention pertains to pharmaceutical compositions comprising certain carbamic acid compounds (e.g., which inhibit HDAC (histone deacetylase) activity) (e.g., PXD-101, N hydroxy-3-(3-phenylsulfamoyl-phenyl)-acrylamide)) and one or more additional ingredients selected from cyclodextrin, arginine, and meglumine. The present invention also pertains to the use of such compositions, for example, in the inhibition of HDAC, and in the treatment of conditions mediated by HDAC, cancer, proliferative conditions, psoriasis, etc.
    Patent expiration dates:
    • October 27, 2027
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      Drug product

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:
    • July 3, 2019 - NEW CHEMICAL ENTITY
    • July 3, 2021 - ORPHAN DRUG EXCLUSIVITY

Glossary

TermDefinition
Drug PatentA drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug ExclusivityExclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLDA Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
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