Generic Treanda Availability
Treanda is a brand name of bendamustine, approved by the FDA in the following formulation(s):
TREANDA (bendamustine hydrochloride - powder;iv (infusion))
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Manufacturer: CEPHALON
Approval date: March 20, 2008
Strength(s): 100MG/VIAL [RLD] [AP] -
Manufacturer: CEPHALON
Approval date: May 1, 2009
Strength(s): 25MG/VIAL [RLD] [AP]
TREANDA (bendamustine hydrochloride - solution;iv (infusion))
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Manufacturer: CEPHALON
Approval date: September 13, 2013
Strength(s): 45MG/0.5ML (90MG/ML) [RLD], 180MG/2ML (90MG/ML) [RLD]
Has a generic version of Treanda been approved?
A generic version of Treanda has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Treanda and have been approved by the FDA:
bendamustine hydrochloride powder;iv (infusion)
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Manufacturer: ACCORD HLTHCARE
Approval date: May 19, 2016
Strength(s): 25MG/VIAL [AP], 100MG/VIAL [AP] -
Manufacturer: GLENMARK PHARMS LTD
Approval date: March 24, 2016
Strength(s): 25MG/VIAL [AP], 100MG/VIAL [AP] -
Manufacturer: HOSPIRA INC
Approval date: May 20, 2016
Strength(s): 25MG/VIAL [AP], 100MG/VIAL [AP] -
Manufacturer: INNOPHARMA LICENSING
Approval date: March 24, 2016
Strength(s): 25MG/VIAL [AP], 100MG/VIAL [AP]
Note: No generic formulation of the following product is available.
- bendamustine hydrochloride - solution;iv (infusion)
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Treanda. 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.
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Liquid formulations of bendamustine
Patent 8,344,006
Issued: January 1, 2013
Inventor(s): Drager; Anthony S. & Labell; Rachel Y. & Patel; Piyush R.
Assignee(s): Cephalon, Inc.
Stable liquid formulations of bendamustine, and pharmaceutically acceptable salts thereof, and polar aprotic solvents, are described.Patent expiration dates:- September 23, 2029✓✓
- March 23, 2030✓
- September 23, 2029
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Bendamustine pharmaceutical compositions
Patent 8,436,190
Issued: May 7, 2013
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:- October 26, 2030✓
- April 26, 2031✓
- October 26, 2030
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Solid forms of bendamustine hydrochloride
Patent 8,445,524
Issued: May 21, 2013
Assignee(s): Cephalon, Inc.
Novel solid forms of bendamustine hydrochloride are described, as well as methods of their preparation and use.Patent expiration dates:- March 26, 2029✓✓✓
- March 26, 2029✓
- September 26, 2029✓
- March 26, 2029
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Bendamustine pharmaceutical compositions
Patent 8,609,863
Issued: December 17, 2013
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✓
- July 12, 2026✓
- January 12, 2026
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Solid forms of bendamustine hydrochloride
Patent 8,669,279
Issued: March 11, 2014
Assignee(s): Cephalon, Inc.
Novel solid forms of bendamustine hydrochloride are described, as well as methods of their preparation and use.Patent expiration dates:- March 26, 2029✓✓
- September 26, 2029✓
- March 26, 2029
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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✓✓
- July 12, 2026✓
- January 12, 2026
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Solid forms of bendamustine hydrochloride
Patent 8,883,836
Issued: November 11, 2014
Assignee(s): Cephalon, Inc.
Novel solid forms of bendamustine hydrochloride are described, as well as methods of their preparation and use.Patent expiration dates:- March 26, 2029✓✓
- September 26, 2029✓
- March 26, 2029
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Bendamustine pharmaceutical compositions
Patent 8,895,756
Issued: November 25, 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✓
- July 12, 2026✓
- January 12, 2026
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:
- September 20, 2015 - PEDIATRIC EXCLUSIVITY
- October 31, 2015 - ORPHAN DRUG EXCLUSIVITY
- May 1, 2016 - PEDIATRIC EXCLUSIVITY
More about Treanda (bendamustine)
Consumer resources
- Other brands: Bendeka
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. |
| 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. |
