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Generic Zytiga Availability

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

ZYTIGA (abiraterone acetate - tablet;oral)

  • Manufacturer: JANSSEN BIOTECH
    Approval date: April 28, 2011
    Strength(s): 250MG [RLD]
  • Manufacturer: JANSSEN BIOTECH
    Approval date: April 14, 2017
    Strength(s): 500MG [RLD]

Has a generic version of Zytiga been approved?

An Authorized Generic version of Zytiga has been approved. An Authorized Generic is a prescription drug that is produced by a brand company under a New Drug Application (NDA) and marketed as a generic under a private label. It is identical to the branded product in appearance, and unlike a generic, the Authorized Generic has exactly the same inactive ingredients.

List of authorized generic versions:

  • Abiraterone acetate ORAL TABLET 250 mg
    Janssen Biotech, Inc.
    NDC Code: 578940155

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

  • Methods and compositions for treating cancer
    Patent 8,822,438
    Issued: September 2, 2014
    Assignee(s): Janssen Oncology, Inc.
    Methods and compositions for treating cancer are described herein. More particularly, the methods for treating cancer comprise administering a 17α-hydroxylase/C17,20-lyase inhibitor, such as abiraterone acetate (i.e., 3β-acetoxy-17-(3-pyridyl)androsta-5,16-diene), in combination with at least one additional therapeutic agent such as an anti-cancer agent or a steroid. Furthermore, disclosed are compositions comprising a 17α-hydroxylase/C17,20-lyase inhibitor, and at least one additional therapeutic agent, such as an anti-cancer agent or a steroid.
    Patent expiration dates:
    • August 24, 2027
      ✓ 
      Patent use: USE IN COMBINATION WITH PREDNISONE FOR THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER
    • August 24, 2027
      ✓ 
      Patent use: USE IN COMBINATION WITH PREDNISONE FOR THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER WHO HAD RECEIVED PRIOR DOCETAXEL CHEMOTHERAPY
    • August 24, 2027
      ✓ 
      Patent use: USE IN COMBINATION WITH PREDNISONE FOR THE TREATMENT OF PATIENTS WITH METASTATIC HIGH-RISK 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:
    • February 7, 2021 - ABIRATERONE ACETATE IN COMBINATION WITH PREDNISONE FOR THE TREATMENT OF PATIENTS WITH METASTATIC HIGH-RISK CASTRATION-SENSITIVE PROSTATE CANCER
Glossary
TermDefinition
Drug PatentA 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 ExclusivityExclusivity 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.
RLDA 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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