Generic Busulfex Availability

Busulfex is a brand name of busulfan, approved by the FDA in the following formulation(s):

BUSULFEX (busulfan - injectable;injection)

  • Manufacturer: OTSUKA PHARM
    Approval date: February 4, 1999
    Strength(s): 6MG/ML [RLD]

Has a generic version of Busulfex been approved?

No. There is currently no therapeutically equivalent version of Busulfex available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Busulfex. 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.

  • Parenteral busulfan for treatment of malignant disease
    Patent 5,430,057
    Issued: July 4, 1995
    Inventor(s): Andersson; Borje S. & Bhagwatwar; Harshal P. & Chow; Diana S. L.
    Assignee(s): Board of Regents, The University of Texas System University of Houston-University Park
    Stable parenteral formulations of busulfan safe for parenteral administration are disclosed that exhibit improved bioavailability and optimize high dose busulfan therapy against malignant disease.
    Patent expiration dates:
    • September 30, 2013
      ✓ 
      Patent use: METHOD OF TREATING A MALIGNANT CONDITION THROUGH INTRAVASCULAR ADMINISTRATION OF BUSULFAN. METHOD FOR TREATING LEUKEMIA OR LYMPHOMA IN A PATIENT UNDERGOING A BONE MARROW TRANSPLANT THROUGH INTRAVENOUS ADMINISTRATION OF BUSULFAN
    • March 30, 2014
      ✓ 
      Pediatric exclusivity
  • Parenteral busulfan for treatment of malignant disease
    Patent 5,559,148
    Issued: September 24, 1996
    Inventor(s): Andersson; Borje S. & Bhagwatwar; Harshal P. & Chow; Diana S.
    Assignee(s): Board of Regents, The University of Texas System University of Houston-University Park
    Stable parenteral formulations of busulfan for parenteral administration are disclosed. The improved bioavailability of the parenteral formulations optimizes high dose busulfan therapy against malignant disease and improves the safety of such therapy.
    Patent expiration dates:
    • September 30, 2013
      ✓ 
      Patent use: METHOD OF TREATING A MALIGNANT DISEASE THROUGH PARENTERAL ADMINISTRATION OF BUSULFAN. METHOD FOR TREATING A PATIENT UNDERGOING A BONE MARROW TRANSPLANT THROUGH INTRAVASCULAR ADMINISTRATION OF BUSULFAN
    • March 30, 2014
      ✓ 
      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.

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