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Generic Xtandi Availability

Last updated on Oct 6, 2021.

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

XTANDI (enzalutamide - capsule;oral)

  • Manufacturer: ASTELLAS
    Approval date: August 31, 2012
    Strength(s): 40MG [RLD] [AB]

XTANDI (enzalutamide - tablet;oral)

  • Manufacturer: ASTELLAS
    Approval date: August 4, 2020
    Strength(s): 40MG [RLD], 80MG [RLD]

Has a generic version of Xtandi been approved?

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

enzalutamide capsule;oral

  • Manufacturer: ACTAVIS LABS FL INC
    Approval date: May 14, 2021
    Strength(s): 40MG [AB]

Note: No generic formulation of the following product is available.

  • enzalutamide - tablet;oral

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

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.

  • Diarylhydantoin compounds
    Patent 7,709,517
    Issued: May 4, 2010
    Inventor(s): Sawyers; Charles L. & Jung; Michael E. & Chen; Charlie D. & Ouk; Samedy & Welsbie; Derek & Tran; Chris & Wongvipat; John & Yoo; Dongwon
    Assignee(s): The Regents of the University of California

    The present invention relates to diarylhydantoin compounds, including diarylthiohydantoins, and methods for synthesizing them and using them in the treatment of hormone refractory prostate cancer.

    Patent expiration dates:

    • August 13, 2027
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      Drug substance
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      Drug product
  • Treatment of hyperproliferative disorders with diarylhydantoin compounds
    Patent 8,183,274
    Issued: May 22, 2012
    Inventor(s): Sawyers; Charles L. & Jung; Michael E. & Chen; Charlie D. & Ouk; Samedy & Tran; Chris & Wongvipat; John
    Assignee(s): The Regents of the University of California

    The present invention relates to diarylhydantoin compounds, including diarylthiohydantoins, and methods for synthesizing them and using them in the treatment of hormone refractory prostate cancer.

    Patent expiration dates:

    • August 24, 2026
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      Patent use: THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER WHO HAVE PREVIOUSLY RECEIVED DOCETAXEL
    • August 24, 2026
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      Patent use: THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (CRPC).
    • August 24, 2026
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      Patent use: THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER
    • August 24, 2026
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      Patent use: TREATMENT OF PATIENTS WITH CASTRATION-RESISTANT PROSTATE CANCER (CRPC)
  • Treatment of hyperproliferative disorders with diarylhydantoin compounds
    Patent 9,126,941
    Issued: September 8, 2015
    Assignee(s): The Regents of the University of California

    The present invention relates to diarylhydantoin compounds, including diarylthiohydantoins, and methods for synthesizing them and using them in the treatment of hormone refractory prostate cancer.

    Patent expiration dates:

    • May 15, 2026
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      Patent use: TREATMENT OF PATIENTS WITH CASTRATION-RESISTANT PROSTATE CANCER (CRPC)
    • May 15, 2026
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      Patent use: THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (CRPC).
    • May 15, 2026
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      Patent use: THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER

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:

    • July 13, 2021 - TREATMENT OF PATIENTS WITH NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER
    • December 16, 2022 - TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (MCSPC)

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.
AB Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (e.g. AB1, AB2, AB7). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.

Further information

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