Generic Belrapzo Availability
Last updated on Jun 11, 2025.
Belrapzo is a brand name of bendamustine, approved by the FDA in the following formulation(s):
BELRAPZO (bendamustine hydrochloride - solution;intravenous)
Is there a generic version of Belrapzo available?
No. There is currently no therapeutically equivalent version of Belrapzo available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Belrapzo. 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 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✓✓
- 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✓✓
- January 12, 2026
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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
More about Belrapzo (bendamustine)
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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. |
| AP | Injectable aqueous solutions and, in certain instances, intravenous non-aqueous solutions. It should be noted that even though injectable (parenteral) products under a specific listing may be evaluated as therapeutically equivalent, there may be important differences among the products in the general category, Injectable; Injection. For example, some injectable products that are rated therapeutically equivalent are labeled for different routes of administration. In addition, some products evaluated as therapeutically equivalent may have different preservatives or no preservatives at all. Injectable products available as dry powders for reconstitution, concentrated sterile solutions for dilution, or sterile solutions ready for injection are pharmaceutical alternative drug products. They are not rated as therapeutically equivalent (AP) to each other even if these pharmaceutical alternative drug products are designed to produce the same concentration prior to injection and are similarly labeled. Consistent with accepted professional practice, it is the responsibility of the prescriber, dispenser, or individual administering the product to be familiar with a product's labeling to assure that it is given only by the route(s) of administration stated in the labeling. |
Further information
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