Skip to Content

Generic Xofigo Availability

Xofigo is a brand name of radium 223 dichloride, approved by the FDA in the following formulation(s):

XOFIGO (radium ra-223 dichloride - solution;intravenous)

  • Manufacturer: BAYER HLTHCARE
    Approval date: May 15, 2013
    Strength(s): 162mCi/6ML (27mCi/ML) [RLD]

Has a generic version of Xofigo been approved?

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

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

  • Preparation and use of radium-223 to target calcified tissues for pain palliation, bone cancer therapy, and bone surface conditioning
    Patent 6,635,234
    Issued: October 21, 2003
    Inventor(s): Roy H.; Larsen & Gjermund; Henriksen & Øyvind S.; Bruland
    Assignee(s): Anticancer Therapeutic Inventions AS
    Processes for the preparation, prepared solutions, and the use of radium-223 for the treatment of calcified tumors, bone tumors, treatment of bones, bone surfaces and soft tissues is described.
    Patent expiration dates:
    • January 3, 2020
      ✓ 
      Patent use: THERAPEUTIC TREATMENT OF BONE METASTASES

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:
    • May 15, 2018 - NEW CHEMICAL ENTITY

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.
Hide