Generic Erleada Availability
Last updated on Sep 11, 2024.
Erleada is a brand name of apalutamide, approved by the FDA in the following formulation(s):
ERLEADA (apalutamide - tablet;oral)
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Manufacturer: JANSSEN BIOTECH
Approval date: February 14, 2018
Strength(s): 60MG [RLD] -
Manufacturer: JANSSEN BIOTECH
Approval date: February 17, 2023
Strength(s): 240MG [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 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.
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Anti-androgens for the treatment of non-metastatic castrate-resistant prostate cancer
Patent 10,052,314
Issued: August 21, 2018
Inventor(s): Chen Isan
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✓✓
- September 23, 2033✓✓
- September 23, 2033
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Anti-androgens for the treatment of non-metastatic castration-resistant prostate cancer
Patent 10,702,508
Issued: July 7, 2020
Inventor(s): Molina Arturo
Assignee(s): Aragon Pharmaceuticals, Inc.Described herein are methods of treating non-metastatic castrate-resistant prostate cancer using an approved drug product comprising apalutamide, enzalutamide or darolutamide. Also described here are drug products containing apalutamide enzalutamide or darolutamide, and methods of selling or offering for sale an anti-androgen drug product.
Patent expiration dates:
- April 30, 2038✓
- April 30, 2038
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Anti-androgens for the treatment of non-metastatic castrate-resistant prostate cancer
Patent 10,849,888
Issued: December 1, 2020
Inventor(s): Chen Isan
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✓
- September 23, 2033
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Patent 11,963,952
Patent expiration dates:
- January 30, 2040✓
- January 30, 2040
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Androgen receptor modulator for the treatment of prostate cancer and androgen receptor-associated diseases
Patent 8,445,507
Issued: May 21, 2013
Inventor(s): Jung Michael E. & Sawyers Charles L. & Ouk Samedy & Tran Chris & Wongvipat John
Assignee(s): The Regents of the University of CaliforniaA hydantoin compound useful for the prevention or treatment of hyperproliferative diseases or disorders.
Patent expiration dates:
- September 15, 2030✓✓✓
- September 15, 2030✓✓✓
- September 15, 2030
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Androgen receptor modulator for the treatment of prostate cancer and androgen receptor-associated diseases
Patent 8,802,689
Issued: August 12, 2014
Inventor(s): Jung Michael E. & Sawyers Charles L. & Ouk Samedy & Tran Chris & Wongvipat John
Assignee(s): The Regents of the University of CaliforniaDescribed herein, inter alia, are compounds useful for the prevention or treatment of hyperproliferative diseases or disorders.
Patent expiration dates:
- March 27, 2027✓
- March 27, 2027✓
- March 27, 2027
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Substituted diazaspiroalkanes as androgen receptor modulators
Patent 9,388,159
Issued: July 12, 2016
Inventor(s): Jung Michael E. & Sawyers Charles L. & Ouk Samedy & Tran Chris & Wongvipat John
Assignee(s): THE REGENTS OF THE UNIVERSITY OF CALIFORNIAThis invention provides for compounds of the Formula II:
Patent expiration dates:
- March 27, 2027✓✓
- March 27, 2027
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Crystalline forms of an androgen receptor modulator
Patent 9,481,663
Issued: November 1, 2016
Inventor(s): Dilhas Anna & Herbert Mark R & Ouerfelli Ouathek & Smith Nicholas DDescribed 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✓✓✓
- June 4, 2033✓✓✓
- June 4, 2033
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Anti-androgens for the treatment of non-metastatic castrate-resistant prostate cancer
Patent 9,884,054
Issued: February 6, 2018
Inventor(s): Chen Isan
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✓
- September 23, 2033
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Substituted diazaspiroalkanes as androgen receptor modulators
Patent 9,987,261
Issued: June 5, 2018
Inventor(s): Jung Michael E. & Sawyers Charles L. & Ouk Samedy & Tran Chris & Wongvipat John
Assignee(s): The Regents of the University of CaliforniaDescribed herein, inter alia, are compounds useful for the prevention or treatment of hyperproliferative diseases or disorders.
Patent expiration dates:
- March 27, 2027✓
- March 27, 2027
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Patent RE49353
Patent expiration dates:
- September 23, 2033✓
- September 23, 2033
More about Erleada (apalutamide)
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- Reviews (16)
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- During pregnancy
- FDA approval history
- Drug class: antiandrogens
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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. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.