Generic Nubeqa Availability

Last updated on Jun 11, 2025.

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]

Is there a generic version of Nubeqa available?

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
  Inventor(s): Törmäkangas Olli & Heikkinen Terhi
  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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• Carboxamide derivative and its diastereomers in stable crystalline form
  Patent 10,383,853
  Issued: August 20, 2019
  Inventor(s): Törmäkangas Olli & Heikkinen Terhi
  Assignee(s): Orion 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
    
    ✓ 
    Drug substance
• Androgen receptor modulating compounds
  Patent 10,711,013
  Issued: July 14, 2020
  Inventor(s): Wohlfahrt Gerd & Törmäkangas Olli & Salo Harri & Höglund Iisa & Karjalainen Arja & Koivikko Pia & Holm Patrik & Rasku Sirpa & Vesalainen Anniina
  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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• Carboxamide derivative and its diastereomers in stable crystalline form
  Patent 10,835,515
  Issued: November 17, 2020
  Inventor(s): Törmäkangas Olli & Heikkinen Terhi
  Assignee(s): ORION 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
    
    ✓ 
    Patent use: TREATMENT OF PATIENTS WITH NON-METASTATIC CASTRATION RESISTANT PROSTATE CANCER
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    Drug product
• Androgen receptor modulating compounds
  Patent 11,046,713
  Issued: June 29, 2021
  Inventor(s): Wohlfahrt Gerd & Törmäkangas Olli & Salo Harri & Höglund Iisa & Karjalainen Arja & Koivikko Pia & Holm Patrik & Rasku Sirpa & Vesalainen Anniina
  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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    Drug substance
• Manufacture of a crystalline pharmaceutical product
  Patent 11,168,058
  Issued: November 9, 2021
  Inventor(s): Reunanen Merja & Staffans Anna
  Assignee(s): ORION CORPORATION
  

  The present disclosure relates to crystalline particles of N—((S)-1-(3-(3-chloro-4-cyanophenyl)-1H-pyrazol-1-yl)-propan-2-yl)-5-(1-hydroxyethyl)-1H-pyrazole-3-carboxamide (I) having specific surface area (SSA) in the range from about 8 to about 16 m/g, preferably from about 10 to about 15 m/g, and to the method for the preparation of such particles. Compound (I) is a potent androgen receptor (AR) modulator which is useful as a medicament for example in the treatment of prostate cancer.

  Patent expiration dates:

  • February 27, 2038
    
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• Androgen receptor modulating compounds
  Patent 8,975,254
  Issued: March 10, 2015
  Inventor(s): Wohlfahrt Gerd & Törmäkangas Olli & Salo Harri & Höglund Iisa & Karjalainen Arja & Knuuttila Pia & Holm Patrik & Rasku Sirpa & Vesalainen Anniina
  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:

  • March 25, 2033
    
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    Patent use: TREATMENT OF PATIENTS WITH NON-METASTATIC CASTRATION RESISTANT PROSTATE CANCER
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• Androgen receptor modulating compounds
  Patent 9,657,003
  Issued: May 23, 2017
  Inventor(s): Wohlfahrt Gerd & Törmäkangas Olli & Salo Harri & Höglund Iisa & Karjalainen Arja & Koivikko Pia & Holm Patrik & Rasku Sirpa & Vesalainen Anniina
  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
    
    ✓ 
    Patent use: TREATMENT OF PATIENTS WITH NON-METASTATIC CASTRATION RESISTANT PROSTATE CANCER
    ✓ 
    Drug substance
    ✓ 
    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:

  • August 5, 2025 - TREATMENT OF ADULT PATIENTS WITH METASTATIC HORMONE‐SENSITIVE PROSTATE CANCER (MHSPC) IN COMBINATION WITH DOCETAXEL

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Further information

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

Medical Disclaimer