Prescription medicine
Triptorelin Brand names: Trelstar, Triptodur
Triptorelin (Triptodur) is a prescription medicine with an FDA approval on record since 2000. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the triptorelin FDA label on DailyMed (effective June 30, 2026, Verity Pharmaceuticals Inc.); the NDA 20715 record on Drugs@FDA; every triptorelin label on DailyMed.
Highlights of the record
FDA label of June 30, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageTRELSTAR is indicated for the treatment of advanced prostate cancer [ see Clinical Studies (14) ].
Forms and strengths
Kit.
On the market
- Earliest approval on file
- June 15, 2000 Trelstar, Verity; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- June 30, 2029 Triptodur Kit 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)
- No recall recorded
- FAERS reports
- 5,869 through July 30, 2026
What is triptorelin used for?
From the label: indications and usageTRELSTAR is indicated for the treatment of advanced prostate cancer [ see Clinical Studies (14) ]. TRELSTAR is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of advanced prostate cancer.
Conditions named in the indications of triptorelin's FDA labels, with every medicine labeled for each:
Source: FDA drug label (Trelstar), Verity Pharmaceuticals Inc., effective June 30, 2026 (SPL set b1b84d62-a369-a4b7-5c41-dd1f553a18f3), via openFDA; the full label on DailyMed
What does the patient leaflet for triptorelin say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about TRIPTODUR?In the first few weeks after your child receives their first TRIPTODUR injection or after additional injections, TRIPTODUR can cause a brief increase in some hormones. During this time you may notice more signs of puberty in your child, including vaginal bleeding. Call your child’s doctor if signs of puberty continue after 2 months of receiving TRIPTODUR. Some people taking gonadotropin releasing hormone (GnRH) agonists like TRIPTODUR have had new or worsened mental (psychiatric) problems. Mental (psychiatric) problems may include emotional symptoms such as: crying irritability restlessness (impatience) anger acting aggressive Call your child’s doctor right away if your child has any new or worsening emotional symptoms while taking TRIPTODUR. Some people taking GnRH agonists like TRIPTODUR have had seizures. The risk of seizures may be higher in people who: have a history of seizures have a history of epilepsy have a history of brain or brain vessel (cerebrovascular) problems or tumors are taking a medicine that has been connected with seizures such as bupropion or selective serotonin reuptake inhibitors (SSRIs) Seizures have also happened in people who have not had any of these problems. Call your child’s doctor right away if your child has a seizure while taking TRIPTODUR. Severe cutaneous (skin) adverse reactions can happen during treatment with GnRH agonists like TRIPTODUR. […]
Source: FDA drug label (TRIPTODUR), Azurity Pharmaceuticals, Inc., effective September 14, 2025 (SPL set f41380e7-b830-432d-a5f5-a872932f107e), via openFDA; the full label on DailyMed
Is there a generic for triptorelin (Triptodur)?
No generic triptorelin is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 1 patent for Triptodur Kit injection, the last expiring on June 30, 2029. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2000 earliest approval on file
- 2029 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the triptorelin label say about other medicines?
The triptorelin 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 |
|---|---|---|
| Bupropion | warnings and precautions | These included patients with a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and patients on concomitant medications that have been associated with convulsions such as bupropion and SSRIs. |
| Testosterone | warnings and precautions | Monitor serum levels of testosterone following injection of TRELSTAR. |
Source: FDA drug label (Trelstar), Verity Pharmaceuticals Inc., effective June 30, 2026 (SPL set b1b84d62-a369-a4b7-5c41-dd1f553a18f3), via openFDA; the full label on DailyMed
What do FAERS reports show for triptorelin?
The FDA Adverse Event Reporting System holds 5,869 reports that list triptorelin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 722 are coded as a death and 1,423 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
What next?
- Triptorelin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other