Generic Orgovyx Availability

Last updated on May 7, 2025.

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

ORGOVYX (relugolix - tablet;oral)

• Manufacturer: SUMITOMO PHARMA
  Approval date: December 18, 2020
  Strength(s): 120MG ^[RLD]

Is there a generic version of Orgovyx available?

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

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

• Solid preparation
  Patent 10,350,170
  Issued: July 16, 2019
  Inventor(s): Yamane Ikuro & Nomura Yukihiro & Nishimoto Yutaka & Hoshina Wataru
  Assignee(s): Takeda Pharmaceutical Company Limited
  

  Provided is a solid preparation showing improved stability of N-(4-(1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxy-3-pyridazinyl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-N′-methoxyurea and a salt thereof in the solid preparation, and a method of stabilizing the compound in a solid preparation.

  Patent expiration dates:

  • February 25, 2036
    
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    Drug product
• Treatment of prostate cancer
  Patent 10,449,191
  Issued: October 22, 2019
  Inventor(s): Rajasekhar; Vijaykumar Reddy et al.
  Assignee(s): Myovant Sciences GmbH (Basel, CH); Takeda Pharmaceutical Company Limited (Osaka, JP)
  

  Methods for treating prostate cancer, including advanced prostate cancer, in a subject in need thereof, include administering once-daily to the subject, at least 80 mg of N-(4-(1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxy-3-pyridazinyl)-2,4-dioxo-1,2,3,4- tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-N′-methoxyurea, or a corresponding amount of a pharmaceutically acceptable salt thereof. Another method includes: administering once-daily to the subject in need thereof, an oral load dose formulation having from 240 mg to 480 mg of N-(4-(1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxy-3-pyridazinyl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-N′-methoxyurea, or a corresponding amount of a pharmaceutically acceptable salt thereof; and thereafter administering once-daily to the subject, an oral maintenance dose formulation having 80 mg to 160 mg of N-(4-(1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxy-3-pyridazinyl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-N′-methoxyurea, or a corresponding amount of a pharmaceutically acceptable salt thereof.

  Patent expiration dates:

  • September 29, 2037
    
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    Patent use: TREATMENT OF ADULT PATIENTS WITH ADVANCED PROSTATE CANCER
• Treatment of prostate cancer
  Patent 10,786,501
  Issued: September 29, 2020
  Inventor(s): Rajasekhar; Vijaykumar Reddy et al.
  Assignee(s): Myovant Sciences GmbH (Basil, CH); Takeda Pharmaceutical Company Limited (Osaka, JP)
  

  Methods for treating prostate cancer, including advanced prostate cancer, in a subject in need thereof, include administering once-daily to the subject, at least 80 mg of N-(4-(1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxy-3-pyridazinyl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-N′-methoxyurea, or a corresponding amount of a pharmaceutically acceptable salt thereof. Another method includes: administering once-daily to the subject in need thereof, an oral load dose formulation having from 240 mg to 480 mg of N-(4-(1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxy-3-pyridazinyl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-N′-methoxyurea, or a corresponding amount of a pharmaceutically acceptable salt thereof; and thereafter administering once-daily to the subject, an oral maintenance dose formulation having 80 mg to 160 mg of N-(4-(1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxy-3-pyridazinyl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-N′-methoxyurea, or a corresponding amount of a pharmaceutically acceptable salt thereof.

  Patent expiration dates:

  • September 29, 2037
    
    ✓ 
    Patent use: TREATMENT OF ADULT PATIENTS WITH ADVANCED PROSTATE CANCER
• Treatment of prostate cancer
  Patent 11,583,526
  Issued: February 21, 2023
  Inventor(s): Rajasekhar; Vijaykumar Reddy et al.
  Assignee(s): Myovant Sciences GmbH (Basel, CH); Takeda Pharmaceutical Company Limited (Osaka, JP)
  

  Methods for treating prostate cancer, including advanced prostate cancer, in a subject in need thereof, include administering once-daily to the subject, at least 80 mg of N-(4-(1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxy-3-pyridazinyl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-N′-methoxyurea, or a corresponding amount of a pharmaceutically acceptable salt thereof. Another method includes: administering once-daily to the subject in need thereof, an oral load dose formulation having from 240 mg to 480 mg of N-(4-(1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxy-3-pyridazinyl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-N′-methoxyurea, or a corresponding amount of a pharmaceutically acceptable salt thereof; and thereafter administering once-daily to the subject, an oral maintenance dose formulation having 80 mg to 160 mg of N-(4-(1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxy-3-pyridazinyl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-N′-methoxyurea, or a corresponding amount of a pharmaceutically acceptable salt thereof.

  Patent expiration dates:

  • September 29, 2037
    
    ✓ 
    Patent use: TREATMENT OF ADULT PATIENTS WITH ADVANCED PROSTATE CANCER
• Compositions of thienopyrimidine derivatives
  Patent 11,795,178
  Issued: October 24, 2023
  Inventor(s): Fukuoka; Koichiro et al.
  Assignee(s): Takeda Pharmaceutical Company Limited (Osaka, JP)
  

  The present invention provides a production method of a thienopyrimidine derivative or a salt thereof which has a gonadotropin releasing hormone (GnRH) antagonistic action with high quality in high yield. The present invention provides a method of producing a thienopyrirnidine derivative, which comprises reacting 6-(4-aminophenyl)-1-(2,6-difluorobenzyl)-5-dimethylaminomethyl-3-(6-methoxypyridazin-3-yl)thieno[2,3-d]pyrimidine-2,4(1H,3H)-dione or salt thereof, 1,1′-carbonyldiimidazole or a salt thereof and methoxyamine or a salt thereof, and the like.

  Patent expiration dates:

  • September 27, 2033
    
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    Drug substance
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    Drug product
• Treatment of prostate cancer
  Patent 12,097,198
  Issued: September 24, 2024
  Inventor(s): Rajasekhar; Vijaykumar Reddy et al.
  Assignee(s): Sumitomo Pharma Switzerland GmbH (Basel, CH); Takeda Pharmaceutical Company Limited (Osaka, JP)
  

  Methods for treating prostate cancer, including advanced prostate cancer, in a subject in need thereof, include administering once-daily to the subject, at least 80 mg of N-(4-(1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxy-3-pyridazinyl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-N′-methoxyurea, or a corresponding amount of a pharmaceutically acceptable salt thereof. Another method includes: administering once-daily to the subject in need thereof, an oral load dose formulation having from 240 mg to 480 mg of N-(4-(1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxy-3-pyridazinyl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-N′-methoxyurea, or a corresponding amount of a pharmaceutically acceptable salt thereof; and thereafter administering once-daily to the subject, an oral maintenance dose formulation having 80 mg to 160 mg of N-(4-(1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxy-3-pyridazinyl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-N′-methoxyurea, or a corresponding amount of a pharmaceutically acceptable salt thereof.

  Patent expiration dates:

  • September 29, 2037
    
    ✓ 
    Patent use: TREATMENT OF ADULT PATIENTS WITH ADVANCED PROSTATE CANCER
• Treatment of prostate cancer
  Patent 12,144,809
  Issued: November 19, 2024
  Inventor(s): Rajasekhar; Vijaykumar Reddy et al.
  Assignee(s): Sumitomo Pharma Switzerland GmbH (Basel, CH); Takeda Pharmaceutical Company Limited (Osaka, JP)
  

  Methods for treating prostate cancer, including advanced prostate cancer, in a subject in need thereof, include administering once-daily to the subject, at least 80 mg of N-(4-(1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxy-3-pyridazinyl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-N′-methoxyurea, or a corresponding amount of a pharmaceutically acceptable salt thereof. Another method includes: administering once-daily to the subject in need thereof, an oral load dose formulation having from 240 mg to 480 mg of N-(4-(1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxy-3-pyridazinyl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-N′-methoxyurea, or a corresponding amount of a pharmaceutically acceptable salt thereof, and thereafter administering once-daily to the subject, an oral maintenance dose formulation having 80 mg to 160 mg of N-(4-(1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxy-3-pyridazinyl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-N′-methoxyurea, or a corresponding amount of a pharmaceutically acceptable salt thereof.

  Patent expiration dates:

  • September 29, 2037
    
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    Patent use: TREATMENT OF ADULT PATIENTS WITH ADVANCED PROSTATE CANCER, MODIFIED BY DOSE-SEPARATING ADMINISTRATIONS OF RELUGOLIX AND A P-GP INHIBITOR, WHEN CO-ADMINISTRATION OF RELUGOLIX AND THE P-GP INHIBITOR IS UNAVOIDABLE
• Thienopyrimidine compounds and use thereof
  Patent 7,300,935
  Issued: November 27, 2007
  Inventor(s): Cho; Nobuo et al.
  Assignee(s): Takeda Pharmaceutical Company (Osaka, JP)
  

  The present invention provides a compound represented by the formula: ##STR00001## wherein R.sup.1 is a C.sub.1-4alkyl; R.sup.2 is (1) a 5- to 7-membered nitrogen-containing heterocyclic group which may have a substituent selected from the group consisting of (1') a halogen, (2') a hydroxy group, (3') a C.sub.1-4alkyl and (4') a C.sub.1-4alkoxy, (2) a phenyl which may have a substituent selected from the group consisting of (1') a halogen, (2') a C.sub.1-4alkoxy-C.sub.1-4alkyl, (3') a mono-C.sub.1-4alkyl-carbamoyl-C.sub.1-4alkyl, (4') a C.sub.1-4alkoxy and (5') a mono-C.sub.1-4alkylcarbamoyl-C.sub.1-4alkoxy, or the like; R.sup.3 is a C.sub.1-4alkyl; R.sup.4 is a C.sub.1-4alkoxy, or the like; n is an integer of 1 to 4; or a salt thereof, as a thienopyrimidine compound having gonadotropin-releasing hormone antagonistic activity.

  Patent expiration dates:

  • January 28, 2026
    
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    Drug substance
• Substituted thieno[2,3-d]pyrimidin-2,4-dione compounds and uses thereof
  Patent 8,058,280
  Issued: November 15, 2011
  Inventor(s): Cho; Nobuo et al.
  Assignee(s): Takeda Pharmaceutical Company Limited (Fujisawa-Shi, JP)
  

  The present invention provides a compound represented by the formula: ##STR00001## wherein R.sup.1 is a C.sub.1-4 alkyl; R.sup.2 is (1) a 5- to 7-membered nitrogen-containing heterocyclic group which may have a substituent selected from the group consisting of (1') a halogen, (2') a hydroxy group, (3') a C.sub.1-4 alkyl and (4') a C.sub.1-4 alkoxy, (2) a phenyl which may have a substituent selected from the group consisting of (1') a halogen, (2') a C.sub.1-4 alkoxy-C.sub.1-4 alkyl, (3') a mono-C.sub.1-4 alkyl-carbamoyl-C.sub.1-4 alkyl, (4') a C.sub.1-4 alkoxy and (5') a mono-C.sub.1-4 alkylcarbamoyl-C.sub.1-4 alkoxy, or the like; R.sup.3 is a C.sub.1-4 alkyl; R.sup.4 is a C.sub.1-4 alkoxy, or the like; n is an integer of 1 to 4; or a salt thereof, as a thienopyrimidine compound having gonadotropin-releasing hormone antagonistic activity.

  Patent expiration dates:

  • January 28, 2026
    
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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:

  • December 18, 2025 - NEW CHEMICAL ENTITY

Further information

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

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