Generic Bendeka Availability
Last updated on Apr 10, 2025.
Bendeka is a brand name of bendamustine, approved by the FDA in the following formulation(s):
BENDEKA (bendamustine hydrochloride - solution;intravenous)
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Manufacturer: EAGLE PHARMS
Approval date: December 7, 2015
Strength(s): 100MG/4ML (25MG/ML) [RLD]
Is there a generic version of Bendeka available?
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: Generic Drug FAQ.
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.
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Formulations of bendamustine
Patent 10,010,533
Issued: July 3, 2018
Inventor(s): Palepu Nagesh R. & Buxton Philip Christopher
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✓
- January 28, 2031
-
Formulations of bendamustine
Patent 10,052,385
Issued: August 21, 2018
Inventor(s): Sundaram Srikanth
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✓
- March 15, 2033✓
- March 15, 2033
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Formulations of bendamustine
Patent 11,103,483
Issued: August 31, 2021
Inventor(s): Palepu Nagesh R. & Buxton Philip Christopher
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✓✓
- January 28, 2031✓✓
- January 28, 2031
-
Formulations of bendamustine
Patent 11,844,783
Issued: December 19, 2023
Inventor(s): Palepu; Nagesh R. et al.
Assignee(s): Eagle Pharmaceuticals, Inc. (Woodcliff Lake, NJ)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✓
- January 28, 2031✓
- January 28, 2031✓
- January 28, 2031
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Formulations of Bendamustine
Patent 11,872,214
Issued: January 16, 2024
Inventor(s): Palepu; Nagesh R. et al.
Assignee(s): Eagle Pharmaceuticals, Inc. (Woodcliff Lake, NJ)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✓
- January 28, 2031
-
Formulations of bendamustine
Patent 12,138,248
Issued: November 12, 2024
Inventor(s): Palepu; Nagesh R. et al.
Assignee(s): Eagle Pharmaceuticals, Inc. (Woodcliff Lake, NJ)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✓
- January 28, 2031
-
Formulations of bendamustine
Patent 8,609,707
Issued: December 17, 2013
Inventor(s): Palepu Nagesh R. & Buxton Philip Christopher
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✓✓
- August 11, 2031
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Bendamustine pharmaceutical compositions
Patent 8,791,270
Issued: July 29, 2014
Inventor(s): Brittain Jason Edward & Franklin Joe Craig
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✓✓
- January 12, 2026
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Method of treating bendamustine-responsive conditions in patients requiring reduced volumes for administration
Patent 9,000,021
Issued: April 7, 2015
Inventor(s): Sundaram Srikanth & Tarriff Scott L.
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✓
- March 15, 2033
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Formulations of bendamustine
Patent 9,034,908
Issued: May 19, 2015
Inventor(s): Sundaram Srikanth
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✓
- March 15, 2033
-
Formulations of bendamustine
Patent 9,144,568
Issued: September 29, 2015
Inventor(s): Sundaram Srikanth
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✓
- March 15, 2033
-
Formulations of bendamustine
Patent 9,265,831
Issued: February 23, 2016
Inventor(s): Palepu Nagesh R. & Buxton Philip Christopher
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✓
- January 28, 2031
-
Formulations of bendamustine
Patent 9,572,796
Issued: February 21, 2017
Inventor(s): Palepu Nagesh R. & Buxton Philip Christopher
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✓✓
- January 28, 2031✓✓
- January 28, 2031
-
Formulations of bendamustine
Patent 9,572,797
Issued: February 21, 2017
Inventor(s): Palepu Nagesh R. & Buxton Philip Christopher
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✓
- January 28, 2031✓
- January 28, 2031
-
Formulations of bendamustine
Patent 9,572,887
Issued: February 21, 2017
Inventor(s): Sundaram Srikanth
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✓
- March 15, 2033✓
- March 15, 2033
-
Method of treating bendamustine-responsive conditions in patients requiring reduced volumes for administration
Patent 9,579,384
Issued: February 28, 2017
Inventor(s): Sundaram Srikanth & Tarriff Scott L.
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✓
- March 15, 2033✓
- March 15, 2033
-
Formulations of bendamustine
Patent 9,597,397
Issued: March 21, 2017
Inventor(s): Sundaram Srikanth
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✓
- March 15, 2033✓
- March 15, 2033
-
Formulations of bendamustine
Patent 9,597,398
Issued: March 21, 2017
Inventor(s): Sundaram Srikanth
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✓
- March 15, 2033
-
Formulations of bendamustine
Patent 9,597,399
Issued: March 21, 2017
Inventor(s): Sundaram Srikanth
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✓
- March 15, 2033✓
- March 15, 2033
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Glossary
| Term | Definition |
|---|---|
| Drug Patent | A 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 Exclusivity | Exclusivity 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. |
| RLD | A 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. |
Further information
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