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Generic Erleada Availability

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

ERLEADA (apalutamide - tablet;oral)

  • Manufacturer: JANSSEN BIOTECH
    Approval date: February 14, 2018
    Strength(s): 60MG [RLD]

Has a generic version of Erleada been approved?

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

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

  • Anti-androgens for the treatment of non-metastatic castrate-resistant prostate cancer
    Patent 10,052,314
    Issued: August 21, 2018
    Assignee(s): Aragon Pharmaceuticals, Inc.

    Described herein are methods of treating non-metastatic castrate-resistant prostate cancer with anti-androgens.

    Patent expiration dates:

    • September 23, 2033
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      Patent use: TREATMENT IN COMBINATION WITH A GNRH AGONIST OF HIGH RISK NON-METASTATIC, CASTRATION-RESISTANT PROSTATE CANCER (NM-CRPC)
    • September 23, 2033
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      Patent use: TREATMENT IN COMBINATION WITH A GNRH AGONIST OF NON-METASTATIC, CASTRATION-RESISTANT PROSTATE CANCER (NM-CRPC)
  • Androgen receptor modulator for the treatment of prostate cancer and androgen receptor-associated diseases
    Patent 8,445,507
    Issued: May 21, 2013
    Assignee(s): The Regents of the University of California

    A hydantoin compound useful for the prevention or treatment of hyperproliferative diseases or disorders.

    Patent expiration dates:

    • September 15, 2030
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      Patent use: TREATMENT OF NON-METASTATIC, CASTRATION-RESISTANT PROSTATE CANCER (NM-CRPC)
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      Drug substance
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      Drug product
  • Androgen receptor modulator for the treatment of prostate cancer and androgen receptor-associated diseases
    Patent 8,802,689
    Issued: August 12, 2014
    Assignee(s): The Regents of the University of California

    Described herein, inter alia, are compounds useful for the prevention or treatment of hyperproliferative diseases or disorders.

    Patent expiration dates:

    • March 27, 2027
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      Patent use: TREATMENT OF NON-METASTATIC, CASTRATION-RESISTANT PROSTATE CANCER (NM-CRPC)
  • Substituted diazaspiroalkanes as androgen receptor modulators
    Patent 9,388,159
    Issued: July 12, 2016
    Assignee(s): THE REGENTS OF THE UNIVERSITY OF CALIFORNIA

    This invention provides for compounds of the Formula II: wherein A, B, Het, R1, R2 and R3 are as described herein. These compounds are androgen receptor modulators useful for the treatment of androgen receptor-associated conditions.

    Patent expiration dates:

    • March 27, 2027
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      Drug substance
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      Drug product
  • Crystalline forms of an androgen receptor modulator
    Patent 9,481,663
    Issued: November 1, 2016
    Assignee(s): Aragon Pharmaceuticals, Inc. Sloan-Kettering Institute For Cancer Research

    Described herein are amorphous and crystalline forms of the androgen receptor modulator 4-[7-(6-cyano-5-trifluoromethylpyridin-3-yl)-8-oxo-6-thioxo-5,7-diazaspiro[3.4]oct-5-yl]-2-fluoro-N-methylbenzamide. Also described are pharmaceutical compositions suitable for administration to a mammal that include the androgen receptor modulator, and methods of using the androgen receptor modulator, alone and in combination with other compounds, for treating diseases or conditions that are associated with androgen receptor activity.

    Patent expiration dates:

    • June 4, 2033
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      Patent use: TREATMENT OF NON-METASTATIC, CASTRATION-RESISTANT PROSTATE CANCER (NM-CRPC)
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      Drug substance
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      Drug product
  • Anti-androgens for the treatment of non-metastatic castrate-resistant prostate cancer
    Patent 9,884,054
    Issued: February 6, 2018
    Assignee(s): ARAGON PHARMACEUTICALS, INC.

    Described herein are methods of treating non-metastatic castrate-resistant prostate cancer with anti-androgens.

    Patent expiration dates:

    • September 23, 2033
      ✓ 
      Patent use: TREATMENT OF NON-METASTATIC, CASTRATION-RESISTANT PROSTATE CANCER (NM-CRPC)
  • Substituted diazaspiroalkanes as androgen receptor modulators
    Patent 9,987,261
    Issued: June 5, 2018
    Assignee(s): The Regents of the University of California

    Described herein, inter alia, are compounds useful for the prevention or treatment of hyperproliferative diseases or disorders.

    Patent expiration dates:

    • March 27, 2027
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      Drug product

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 14, 2023 - NEW CHEMICAL ENTITY

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.
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