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Generic Faslodex Availability

Last updated on Sep 8, 2022.

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

FASLODEX (fulvestrant - injectable;intramuscular)

  • Manufacturer: ASTRAZENECA
    Approval date: April 25, 2002
    Strength(s): 50MG/ML [RLD] [AO]

Has a generic version of Faslodex been approved?

Yes. The following products are equivalent to Faslodex:

fulvestrant injectable;intramuscular

  • Manufacturer: ACCORD HLTHCARE
    Approval date: November 17, 2020
    Strength(s): 50MG/ML [AO]
  • Manufacturer: AMNEAL
    Approval date: March 4, 2019
    Strength(s): 50MG/ML [AO]
  • Manufacturer: CHIA TAI TIANQING
    Approval date: February 7, 2020
    Strength(s): 50MG/ML [AO]
  • Manufacturer: DR REDDYS
    Approval date: August 7, 2020
    Strength(s): 50MG/ML [AO]
  • Manufacturer: EUGIA PHARMA
    Approval date: July 23, 2019
    Strength(s): 50MG/ML [AO]
  • Manufacturer: GLENMARK PHARMS INC
    Approval date: August 22, 2019
    Strength(s): 50MG/ML [AO]
  • Manufacturer: HBT LABS INC
    Approval date: November 21, 2019
    Strength(s): 50MG/ML [AO]
  • Manufacturer: JIANGSU HANSOH PHARM
    Approval date: February 10, 2022
    Strength(s): 50MG/ML [AO]
  • Manufacturer: SAGENT PHARMS INC
    Approval date: August 22, 2019
    Strength(s): 50MG/ML [AO]
  • Manufacturer: SANDOZ INC
    Approval date: May 14, 2019
    Strength(s): 50MG/ML [AO]
  • Manufacturer: XIROMED
    Approval date: August 13, 2021
    Strength(s): 50MG/ML [AO]
  • Manufacturer: ZYDUS PHARMS
    Approval date: July 29, 2021
    Strength(s): 50MG/ML [AO]

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

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.
AO Injectable oil solutions. The absorption of drugs in injectable (parenteral) oil solutions may vary substantially with the type of oil employed as a vehicle and the concentration of the active ingredient. Injectable oil solutions are therefore considered to be pharmaceutically and therapeutically equivalent only when the active ingredient, its concentration, and the type of oil used as a vehicle are all identical.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.