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Generic Nubeqa Availability

Last updated on Aug 10, 2022.

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

NUBEQA (darolutamide - tablet;oral)

  • Manufacturer: BAYER HEALTHCARE
    Approval date: July 30, 2019
    Strength(s): 300MG [RLD]

Has a generic version of Nubeqa been approved?

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

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

  • Carboxamide derivative and its diastereomers in stable crystalline form
    Patent 10,010,530
    Issued: July 3, 2018
    Assignee(s): Orlon Corporation

    The present disclosure relates to solid crystalline forms of N—((S)-1-(3-(3-chloro-4-cyanophenyl)-1H-pyrazol-1-yl)-propan-2-yl)-5-(1-hydroxyethyl)-1H-pyrazole-3-carboxamide (I) and the diastereomers thereof, and to methods for preparing such crystalline forms. Compound (I) and the diastereomers thereof are potent androgen receptor (AR) modulators useful as a medicament.

    Patent expiration dates:

    • January 28, 2036
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      Drug substance
  • Patent 10,383,853

    Patent expiration dates:

    • January 28, 2036
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      Drug substance
  • Patent 10,711,013

    Patent expiration dates:

    • October 27, 2030
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      Drug substance
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      Drug product
  • Patent 10,835,515

    Patent expiration dates:

    • January 28, 2036
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      Patent use: TREATMENT OF PATIENTS WITH NON-METASTATIC CASTRATION RESISTANT PROSTATE CANCER
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      Drug product
  • Patent 11,046,713

    Patent expiration dates:

    • October 27, 2030
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      Drug substance
  • Patent 11,168,058

    Patent expiration dates:

    • February 27, 2038
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      Drug substance
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      Drug product
  • Androgen receptor modulating compounds
    Patent 8,975,254
    Issued: March 10, 2015
    Assignee(s): Orion Corporation

    The present disclosure relates to compounds of formula (I), and pharmaceutically acceptable salts thereof. The present disclosure also relates to compositions and methods of treating comprising compounds of formula (I), and pharmaceutically acceptable salts thereof.

    Patent expiration dates:

    • October 27, 2030
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      Patent use: TREATMENT OF PATIENTS WITH NON-METASTATIC CASTRATION RESISTANT PROSTATE CANCER
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      Drug substance
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      Drug product
  • Androgen receptor modulating compounds
    Patent 9,657,003
    Issued: May 23, 2017
    Assignee(s): ORION CORPORATION

    The present disclosure relates to compounds of formula (I), and pharmaceutically acceptable salts thereof. The present disclosure also relates to compositions and methods of treating comprising compounds of formula (I), and pharmaceutically acceptable salts thereof.

    Patent expiration dates:

    • October 27, 2030
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      Patent use: TREATMENT OF PATIENTS WITH NON-METASTATIC CASTRATION RESISTANT PROSTATE CANCER
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      Drug substance
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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:

    • July 30, 2024 - NEW CHEMICAL ENTITY

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.

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