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Generic Faslodex Availability

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] [AP]

Has a generic version of Faslodex been approved?

A generic version of Faslodex 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 Faslodex and have been approved by the FDA:

fulvestrant injectable;intramuscular

  • Manufacturer: AMNEAL PHARMS CO
    Approval date: March 4, 2019
    Strength(s): 50MG/ML [AP]

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 FAQs.

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.

  • Formulation
    Patent 6,774,122
    Issued: August 10, 2004
    Inventor(s): John R; Evans & Rosalind U; Grundy
    Assignee(s): AstraZeneca AB

    The invention relates to a novel sustained release pharmaceutical formulation adapted for administration by injection containing the compound 7&agr;-[9-(4,4,5,5,5-pentafluoropentylsulphinyl)nonyl]oestra-1,3,5(10)-triene-3,17&bgr;-diol, more particularly to a formulation adapted for administration by injection containing the compound 7&agr;-[9-(4,4,5,5,5-pentafluoropentylsulphinyl)nonyl]oestra-1,3,5(10)-triene-3,17&bgr;-diol in solution in a ricinoleate vehicle which additionally comprises at least one alcohol and a non-aqueous ester solvent which is miscible in the ricinoleate vehicle.

    Patent expiration dates:

    • January 9, 2021
      ✓ 
      Patent use: TREATMENT OF HR-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER-2)-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER IN COMBINATION WITH PALBOCICLIB OR ABEMACICLIB IN WOMEN WITH DISEASE PROGRESSION AFTER ENDOCRINE THERAPY
    • January 9, 2021
      ✓ 
      Patent use: TREATMENT OF HR-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER IN COMBINATION WITH PALBOCICLIB IN WOMEN WITH DISEASE PROGRESSION AFTER ENDOCRINE THERAPY
    • January 9, 2021
      ✓ 
      Patent use: TREATMENT OF HORMONE RECEPTOR POSITIVE METASTATIC BREAST CANCER IN POSTMENOPAUSAL WOMEN WITH DISEASE PROGRESSION FOLLOWING ANTIESTROGEN THERAPY
    • January 9, 2021
      ✓ 
      Patent use: TREATMENT OF HORMONE RECEPTOR POSITIVE HER2-NEGATIVE ADVANCED BREAST CANCER IN POSTMENOPAUSAL WOMEN NOT PREVIOUSLY TREATED WITH ENDOCRINE THERAPY
    • July 9, 2021
      ✓ 
      Pediatric exclusivity
  • Formulation
    Patent 7,456,160
    Issued: November 25, 2008
    Inventor(s): Evans; John R & Grundy; Rosalind U
    Assignee(s): AstraZeneca AB

    The invention relates to a novel sustained release pharmaceutical formulation adapted for administration by injection containing the compound 7α-[9-(4,4,5,5,5-pentafluoropentylsulphinyl)nonyl]oestra-1,3,5(10)-triene-3,17β-diol, more particularly to a formulation adapted for administration by injection containing the compound 7α-[9-(4,4,5,5,5-pentafluoropentylsulphinyl)nonyl]oestra-1,3,5(10)-triene-3,17β-diol in solution in a ricinoleate vehicle which additionally comprises at least one alcohol and a non-aqueous ester solvent which is miscible in the ricinoleate vehicle.

    Patent expiration dates:

    • January 9, 2021
      ✓ 
      Patent use: TREATMENT OF HORMONE RECEPTOR POSITIVE METASTATIC BREAST CANCER IN POSTMENOPAUSAL WOMEN WITH DISEASE PROGRESSION FOLLOWING ANTIESTROGEN THERAPY
    • January 9, 2021
      ✓ 
      Patent use: TREATMENT OF HR-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER IN COMBINATION WITH PALBOCICLIB IN WOMEN WITH DISEASE PROGRESSION AFTER ENDOCRINE THERAPY
    • January 9, 2021
      ✓ 
      Patent use: TREATMENT OF HORMONE RECEPTOR POSITIVE HER2-NEGATIVE ADVANCED BREAST CANCER IN POSTMENOPAUSAL WOMEN NOT PREVIOUSLY TREATED WITH ENDOCRINE THERAPY
    • January 9, 2021
      ✓ 
      Patent use: TREATMENT OF HR-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER-2)-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER IN COMBINATION WITH PALBOCICLIB OR ABEMACICLIB IN WOMEN WITH DISEASE PROGRESSION AFTER ENDOCRINE THERAPY
    • July 9, 2021
      ✓ 
      Pediatric exclusivity
  • Formulation
    Patent 8,329,680
    Issued: December 11, 2012
    Inventor(s): Evans; John R & Grundy; Rosalind U
    Assignee(s): AstraZeneca AB

    The invention relates to a novel sustained release pharmaceutical formulation adapted for administration by injection containing the compound 7α-[9-(4,4,5,5,5-pentafluoropentylsulphinyl)nonyl]oestra-1,3,5(10)-triene-3,17β-diol, more particularly to a formulation adapted for administration by injection containing the compound 7α-[9-(4,4,5,5,5-pentafluoropentylsulphinyl)nonyl]oestra-1,3,5(10)-triene-3,17β-diol in solution in a ricinoleate vehicle which additionally comprises at least one alcohol and a non-aqueous ester solvent which is miscible in the ricinoleate vehicle.

    Patent expiration dates:

    • January 9, 2021
      ✓ 
      Patent use: TREATMENT OF HORMONE RECEPTOR POSITIVE METASTATIC BREAST CANCER IN POSTMENOPAUSAL WOMEN WITH DISEASE PROGRESSION FOLLOWING ANTIESTROGEN THERAPY
    • January 9, 2021
      ✓ 
      Patent use: TREATMENT OF HR-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER-2)-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER IN COMBINATION WITH PALBOCICLIB OR ABEMACICLIB IN WOMEN WITH DISEASE PROGRESSION AFTER ENDOCRINE THERAPY
    • January 9, 2021
      ✓ 
      Patent use: TREATMENT OF HR-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER IN COMBINATION WITH PALBOCICLIB IN WOMEN WITH DISEASE PROGRESSION AFTER ENDOCRINE THERAPY
    • January 9, 2021
      ✓ 
      Patent use: TREATMENT OF HORMONE RECEPTOR POSITIVE HER2-NEGATIVE ADVANCED BREAST CANCER IN POSTMENOPAUSAL WOMEN NOT PREVIOUSLY TREATED WITH ENDOCRINE THERAPY
    • July 9, 2021
      ✓ 
      Pediatric exclusivity
  • Formulation
    Patent 8,466,139
    Issued: June 18, 2013
    Assignee(s): AstraZeneca AB

    The invention relates to a novel sustained release pharmaceutical formulation adapted for administration by injection containing the compound 7α-[9-(4,4,5,5,5-pentafluoropentylsulphinyl)nonyl]oestra-1,3,5(10)-triene-3,17β-diol, more particularly to a formulation adapted for administration by injection containing the compound 7α-[9-(4,4,5,5,5-pentafluoropentylsulphinyl)nonyl]oestra-1,3,5(10)-triene-3,17β-diol in solution in a ricinoleate vehicle which additionally comprises at least one alcohol and a non-aqueous ester solvent which is miscible in the ricinoleate vehicle.

    Patent expiration dates:

    • January 9, 2021
      ✓ 
      Patent use: TREATMENT OF HORMONE RECEPTOR POSITIVE METASTATIC BREAST CANCER IN POSTMENOPAUSAL WOMEN WITH DISEASE PROGRESSION FOLLOWING ANTIESTROGEN THERAPY
    • January 9, 2021
      ✓ 
      Patent use: TREATMENT OF HR-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER IN COMBINATION WITH PALBOCICLIB IN WOMEN WITH DISEASE PROGRESSION AFTER ENDOCRINE THERAPY
    • January 9, 2021
      ✓ 
      Patent use: TREATMENT OF HR-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER-2)-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER IN COMBINATION WITH PALBOCICLIB OR ABEMACICLIB IN WOMEN WITH DISEASE PROGRESSION AFTER ENDOCRINE THERAPY
    • January 9, 2021
      ✓ 
      Patent use: TREATMENT OF HORMONE RECEPTOR POSITIVE HER2-NEGATIVE ADVANCED BREAST CANCER IN POSTMENOPAUSAL WOMEN NOT PREVIOUSLY TREATED WITH ENDOCRINE THERAPY
    • July 9, 2021
      ✓ 
      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:

    • February 19, 2019 - TREATMENT OF HORMONE RECEPTOR (HR)-POSITIVE, HER2-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER IN COMBINATION THERAPY WITH PALBOCICLIB AND FULVESTRANT IN WOMEN WITH DISEASE PROGRESSION FOLLOWING ENDOCRINE THERAPY.
    • August 25, 2020 - MONOTHERAPY FOR THE TREATMENT OF HORMONE RECEPTOR (HR) POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE, ADVANCED BREAST CANCER IN POSTMENOPAUSAL WOMEN NOT PREVIOUSLY TREATED WITH ENDOCRINE THERAPY

Further information

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

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.
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