Generic Orgovyx Availability
Last updated on Nov 6, 2024.
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]
Has a generic version of Orgovyx been approved?
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 LimitedProvided 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✓
- February 25, 2036
-
Treatment of prostate cancer
Patent 10,449,191
Issued: October 22, 2019
Inventor(s): Rajasekhar Vijaykumar Reddy & Johnson Brendan Mark & MacLean David B. & Seely Lynn & Mudd & Jr. Paul N.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✓
- September 29, 2037
-
Treatment of prostate cancer
Patent 10,786,501
Issued: September 29, 2020
Inventor(s): Rajasekhar Vijaykumar Reddy & Johnson Brendan Mark & MacLean David B. & Seely Lynn & Mudd & Jr. Paul N.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✓
- September 29, 2037
-
Patent 11,583,526
Patent expiration dates:
- September 29, 2037✓
- September 29, 2037
-
Patent 11,795,178
Patent expiration dates:
- September 27, 2033✓✓
- September 27, 2033
-
Patent 12,097,198
Patent expiration dates:
- September 29, 2037✓
- September 29, 2037
-
Patent 7,300,935
Patent expiration dates:
- January 28, 2025✓
- January 28, 2025
-
Patent 8,058,280
Patent expiration dates:
- January 28, 2025✓✓
- January 28, 2025
-
Thienopyrimidine compounds and use thereof
Patent 8,735,401
Issued: May 27, 2014
Inventor(s): Cho Nobuo & Imada Takashi & Hitaka Takenori & Miwa Kazuhiro & Kusuka Masami & Suzuki Nobuhiro
Assignee(s): Takeda Pharmaceutical Company LimitedThe present invention provides a compound represented by the formula:
Patent expiration dates:
- February 4, 2024✓
- February 4, 2024
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
More about Orgovyx (relugolix)
- Check interactions
- Compare alternatives
- Pricing & coupons
- Reviews (19)
- Drug images
- Side effects
- Dosage information
- During pregnancy
- FDA approval history
- Drug class: gonadotropin-releasing hormone antagonists
- En español
Patient resources
Professional resources
Related treatment guides
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.
