Generic Nubeqa Availability
Last updated on Mar 13, 2025.
Nubeqa is a brand name of darolutamide, approved by the FDA in the following formulation(s):
NUBEQA (darolutamide - tablet;oral)
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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.
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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 CorporationThe 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✓
- 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 CorporationThe 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✓
- January 28, 2036
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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 CORPORATIONThe 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✓✓
- 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 CORPORATIONThe 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✓✓
- January 28, 2036
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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 CORPORATIONThe 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✓
- October 27, 2030
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Manufacture of a crystalline pharmaceutical product
Patent 11,168,058
Issued: November 9, 2021
Inventor(s): Reunanen Merja & Staffans Anna
Assignee(s): ORION CORPORATIONThe 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✓✓
- 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 CorporationThe 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✓✓✓
- March 25, 2033
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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 CORPORATIONThe 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✓✓✓
- October 27, 2030
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
More about Nubeqa (darolutamide)
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- 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.
