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Generic Bendeka Availability

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

BENDEKA (bendamustine hydrochloride - solution;iv (infusion))

  • Manufacturer: EAGLE PHARMS
    Approval date: December 7, 2015
    Strength(s): 100MG/4ML (25MG/ML) [RLD]

Has a generic version of Bendeka been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Bendeka. 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.

  • Formulations of bendamustine
    Patent 8,609,707
    Issued: December 17, 2013
    Assignee(s): Eagle Pharmaceuticals, Inc.
    Long term storage stable bendamustine-containing compositions are disclosed. The compositions can include bendamustine or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable fluid which can include in some embodiments PEG, PG or mixtures thereof and an antioxidant or chloride ion source. The bendamustine-containing compositions have less than about 5% total impurities, on a normalized peak area response (“PAR”) basis as determined by high performance liquid chromatography (“HPLC”) at a wavelength of 223 nm, after at least about 15 months of storage at a temperature of from about 5° C. to about 25° C.
    Patent expiration dates:
    • August 11, 2031
      ✓ 
      Patent use: FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA
      ✓ 
      Drug product
  • Bendamustine pharmaceutical compositions
    Patent 8,791,270
    Issued: July 29, 2014
    Assignee(s): Cephalon, Inc.
    The present invention provides pharmaceutical formulations of lyophilized bendamustine suitable for pharmaceutical use. The present invention further provides methods of producing lyophilized bendamustine. The pharmaceutical formulations can be used for any disease that is sensitive to treatment with bendamustine, such as neoplastic diseases.
    Patent expiration dates:
    • January 12, 2026
      ✓ 
      Patent use: FOR USE IN TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR NON-HODGKIN'S LYMPHOMA
      ✓ 
      Drug product
    • July 12, 2026
      ✓ 
      Pediatric exclusivity
  • Method of treating bendamustine-responsive conditions in patients requiring reduced volumes for administration
    Patent 9,000,021
    Issued: April 7, 2015
    Assignee(s): Eagle Pharmaceuticals, Inc.
    Methods of treating bendamustine responsive conditions in patients having fluid and/or sodium intake restrictions are disclosed. The methods include identifying patients having such restrictions and in need of bendamustine, and then administering thereto a bendamustine-containing composition in a volume of about 120 ml or less intravenously over a period of about 15 minutes or less. The smaller volumes and reduced sodium load as compared to currently known methods of treatment minimize cardiac and/or renal stress in patients having diseases such as congestive heart failure or renal disease.
    Patent expiration dates:
    • March 15, 2033
      ✓ 
      Patent use: FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA
  • Formulations of bendamustine
    Patent 9,034,908
    Issued: May 19, 2015
    Assignee(s): EAGLE PHARMACEUTICALS, INC.
    Methods of treatment using bendamustine formulations designed for small volume intravenous administration are disclosed. The methods conveniently allow shorter administration time without the active ingredient coming out of solution as compared to presently available formulations.
    Patent expiration dates:
    • March 15, 2033
      ✓ 
      Patent use: FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA
  • Formulations of bendamustine
    Patent 9,144,568
    Issued: September 29, 2015
    Assignee(s): EAGLE PHARMACEUTICALS, INC.
    Methods of treatment using bendamustine formulations designed for small volume intravenous administration are disclosed. The methods conveniently allow shorter administration time without the active ingredient coming out of solution as compared to presently available formulations.
    Patent expiration dates:
    • March 15, 2033
      ✓ 
      Patent use: FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA
  • Formulations of bendamustine
    Patent 9,265,831
    Issued: February 23, 2016
    Assignee(s): Eagle Pharmaceuticals, Inc.
    Long term storage stable bendamustine-containing compositions are disclosed. The compositions can include bendamustine or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable fluid which can include in some embodiments PEG, PG or mixtures thereof and an antioxidant or chloride ion source. The bendamustine-containing compositions have less than about 5% total impurities, on a normalized peak area response (“PAR”) basis as determined by high performance liquid chromatography (“HPLC”) at a wavelength of 223 nm, after at least about 15 months of storage at a temperature of from about 5° C. to about 25° C.
    Patent expiration dates:
    • January 28, 2031
      ✓ 
      Drug product

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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