Prescription medicine
Degarelix Brand names: Firmagon
Degarelix (Firmagon) is a prescription medicine with an FDA approval on record since 2008. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the degarelix FDA label on DailyMed (effective January 30, 2024, Ferring Pharmaceuticals Inc.); the NDA 22201 record on Drugs@FDA; every degarelix label on DailyMed.
Highlights of the record
FDA label of January 30, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageFIRMAGON ® is indicated for treatment of patients with advanced prostate cancer.
Forms and strengths
Kit.
On the market
- Earliest approval on file
- December 24, 2008 Firmagon, Ferring; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- April 27, 2032 Firmagon injection; 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)
- 2 since 2022 0 Class I among all firms' recalls; latest April 13, 2022
- FAERS reports
- 5,247 through July 30, 2026
What is degarelix used for?
From the label: indications and usageFIRMAGON ® is indicated for treatment of patients with advanced prostate cancer. FIRMAGON is a GnRH receptor antagonist indicated for treatment of patients with advanced prostate cancer.
Conditions named in the indications of degarelix's FDA labels, with every medicine labeled for each:
Source: FDA drug label (FIRMAGON), Ferring Pharmaceuticals Inc., effective January 30, 2024 (SPL set ab11dd8a-0fd9-4013-89ab-e114557c7e4b), via openFDA; the full label on DailyMed
Is there a generic for degarelix (Firmagon)?
No generic degarelix is approved (Drugs@FDA, October 8, 2026). Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
The Orange Book lists 9 patents for Firmagon injection, the last expiring on April 27, 2032. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2008 earliest approval on file
- 2032 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has degarelix been recalled?
The FDA's Enforcement Report lists 2 recalls naming degarelix since 2022: 0 Class I (the most serious), 2 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 13, 2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | cGMP deviations: Temperature abuse |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the degarelix label say about other medicines?
The degarelix label names 2 other medicines 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 |
|---|---|---|
| Leuprolide | warnings and precautions | Seven patients, three (<1%) in the pooled degarelix group and four (2%) patients in the leuprolide 7.5 mg group, had a QTcF ≥ 500 msec. |
| Testosterone | warnings and precautions | If PSA increases, serum concentrations of testosterone should be measured. |
Source: FDA drug label (FIRMAGON), Ferring Pharmaceuticals Inc., effective January 30, 2024 (SPL set ab11dd8a-0fd9-4013-89ab-e114557c7e4b), via openFDA; the full label on DailyMed
What do FAERS reports show for degarelix?
The FDA Adverse Event Reporting System holds 5,247 reports that list degarelix among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 624 are coded as a death and 1,710 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 received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
How does degarelix compare with medicines for the same use?
1 side-by-side page set degarelix beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Degarelix side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other