Prescription medicine
Relugolix Brand names: Orgovyx
Relugolix (Orgovyx) is a prescription medicine with an FDA approval on record since 2020. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the relugolix FDA label on DailyMed (effective October 10, 2025, Sumitomo Pharma America, Inc.); the NDA 214621 record on Drugs@FDA; every relugolix label on DailyMed.
Highlights of the record
FDA label of October 10, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageORGOVYX is indicated for the treatment of adult patients with advanced prostate cancer.
Forms and strengths
- 120 mg
Film-coated tablet.
On the market
- Earliest approval on file
- December 18, 2020 Orgovyx, Sumitomo Pharma Am; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- September 29, 2037 Orgovyx tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 23,444 through July 30, 2026
What is relugolix used for?
From the label: indications and usageORGOVYX is indicated for the treatment of adult patients with advanced prostate cancer. ORGOVYX is a gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for the treatment of adult patients with advanced prostate cancer ( 1 ).
Conditions named in the indications of relugolix's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Gonadotropin Releasing Hormone Receptor Antagonist.
Source: FDA drug label (Orgovyx), Sumitomo Pharma America, Inc., effective October 10, 2025 (SPL set 077a92f6-9f1b-479a-87c7-c92b5db6aa9c), via openFDA; the full label on DailyMed
Is there a generic for relugolix (Orgovyx)?
No generic relugolix is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 12 patents for Orgovyx tablets: the compound patent runs to September 27, 2033, and the last listed entry to September 29, 2037. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2020 earliest approval on file
- 2037 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the relugolix label say about other medicines?
The relugolix label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Testosterone | warnings and precautions | If PSA increases, serum concentrations of testosterone should be measured. |
Source: FDA drug label (Orgovyx), Sumitomo Pharma America, Inc., effective October 10, 2025 (SPL set 077a92f6-9f1b-479a-87c7-c92b5db6aa9c), via openFDA; the full label on DailyMed
What do FAERS reports show for relugolix?
The FDA Adverse Event Reporting System holds 23,444 reports that list relugolix among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,145 are coded as a death and 2,131 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2025 (10,314, against a median of 5 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as relugolix?
6 other medicines are given the same way (oral) and in the same FDA class as relugolix or labeled mainly for the same use (prostate cancer), the same class first. Prostate cancer lists all 17 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Abiraterone | Prostate cancer | 24 labelers | $0.774 per tablet 250 mg tablet | No current entry |
| Enzalutamide | Prostate cancer | none listed | n/a | No current entry |
| Rucaparib camsylate | Prostate cancer | none listed | n/a | No current entry |
| Abiraterone and niraparib | Prostate cancer | none listed | n/a | No current entry |
| Apalutamide | Prostate cancer | none listed | n/a | No current entry |
| Nilutamide | Prostate cancer | 1 labeler | n/a | A presentation being discontinued |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to relugolix
- 6 medicines for the same use
- Other gonadotropin releasing hormone receptor antagonists
- the pharmacologic class, with prices and generics
- Relugolix side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other