Generic Belrapzo Availability
Belrapzo is a brand name of bendamustine, approved by the FDA in the following formulation(s):
BELRAPZO (bendamustine hydrochloride - solution;iv (infusion))
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Manufacturer: EAGLE PHARMS
Approval date: May 15, 2018
Strength(s): 100MG/4ML (25MG/ML) [RLD]
Has a generic version of Belrapzo been approved?
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 FAQs.
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
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
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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✓✓
- August 11, 2031✓✓
- August 11, 2031
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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✓✓
- January 12, 2026✓✓
- January 12, 2026
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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✓
- January 28, 2031
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Formulations of bendamustine
Patent 9,572,796
Issued: February 21, 2017
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
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Formulations of bendamustine
Patent 9,572,797
Issued: February 21, 2017
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
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
More about Belrapzo (bendamustine)
- Side Effects
- During Pregnancy or Breastfeeding
- Dosage Information
- Drug Interactions
- Pricing & Coupons
- En Español
- Drug class: alkylating agents
- FDA Alerts (1)
Consumer resources
Other brands: Bendeka, Treanda
Professional resources
Related treatment guides
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. |
