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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))

  • 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))

  • 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)

  • 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.

  • 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
      ✓ 
      Patent use: FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR INDOLENT B-CELL NON-HODGKIN LYMPHOMA (NHL)
      ✓ 
      Drug product
    • March 23, 2030
      ✓ 
      Pediatric exclusivity
  • 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
      ✓ 
      Drug product
    • April 26, 2031
      ✓ 
      Pediatric exclusivity
  • 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
      ✓ 
      Patent use: FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR INDOLENT B-CELL NON-HODGKIN LYMPHOMA (NHL)
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • March 26, 2029
      ✓ 
      Drug substance
    • September 26, 2029
      ✓ 
      Pediatric exclusivity
  • 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
      ✓ 
      Drug product
    • July 12, 2026
      ✓ 
      Pediatric exclusivity
  • 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
      ✓ 
      Patent use: FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR INDOLENT B-CELL NON-HODGKIN LYMPHOMA (NHL)
      ✓ 
      Drug product
    • September 26, 2029
      ✓ 
      Pediatric exclusivity
  • 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 THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA
      ✓ 
      Drug product
    • July 12, 2026
      ✓ 
      Pediatric exclusivity
  • 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
      ✓ 
      Patent use: FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR INDOLENT B-CELL NON-HODGKIN LYMPHOMA (NHL)
      ✓ 
      Drug product
    • September 26, 2029
      ✓ 
      Pediatric exclusivity
  • 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
      ✓ 
      Drug product
    • July 12, 2026
      ✓ 
      Pediatric exclusivity

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

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.
APInjectable 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.
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