Home / Generic availability / Triptorelin
When will generic Triptorelin be available?
Based on the patents and exclusivity the FDA lists today, generic triptorelin cannot be marketed in the United States before 2029-06-30, when the last listed protection expires.
Patents listed with the FDA
2 unexpired or current listing(s).
| Patent | Expires | Covers | Product |
|---|---|---|---|
| 10166181 | 2029-06-30 | drug product | TRIPTODUR KIT |
| 10166181 | 2029-06-30 | drug product | TRELSTAR |
Approved products
| Product | Type | Applicant | Approved | |
|---|---|---|---|---|
| TRELSTAR | Brand (NDA) | VERITY PHARMACEUTICALS INC | 2000-06-15 | reference listed drug, reference standard |
| TRELSTAR | Brand (NDA) | VERITY PHARMACEUTICALS INC | 2001-06-29 | reference listed drug, reference standard |
| TRELSTAR | Brand (NDA) | VERITY PHARMACEUTICALS INC | 2010-03-10 | reference listed drug, reference standard |
| TRIPTODUR KIT | Brand (NDA) | AZURITY PHARMACEUTICALS INC | 2017-06-29 | reference listed drug, reference standard |
What a generic Triptorelin would have to match
Forms and strengths
For injectable suspension: 3.75 mg, 11.25 mg, 22.5 mg of slightly yellow lyophilized microgranules in a single-dose vial for reconstitution with an injection kit containing one syringe filled with sterile water for injection, a vial adapter to help with reconstitution, and one needle (see figure in section 2.2). For injectable suspension: 3.75 mg, 11.25 mg, 22.5 mg. ( 3 )
How it is supplied
TRELSTAR (triptorelin pamoate for injectable suspension) is supplied as a single dose vial with a Flip-Off cap containing sterile lyophilized triptorelin pamoate microgranules incorporated in a biodegradable copolymer of lactic and glycolic acids, with injection kit consisting of a vial adapter, a 21 gauge 1 ½” injection needle, and a pre-filled syringe containing sterile water for injection, USP, 2 mL. TRELSTAR 3.75 mg, NDC 74676-5902-1: 3.75 mg of slightly yellow microgranules provided in a vial with a violet flip-off cap with injection kit. TRELSTAR 11.25 mg, NDC 74676-5904-1: 11.25 mg of slightly yellow microgranules provided in a vial with a yellow green flip-off cap with injection...
A generic has to match the reference product on active ingredient, strength, dosage form and route. These are the forms the FDA label currently lists. Source: FDA Structured Product Labeling, label effective 2026-06-30.
Other drugs and when their protection ends
Ordered by the date the last listed patent or exclusivity expires.
- Afamelanotideprotection runs to January 2033
- Bremelanotideprotection runs to November 2033
- Vasopressinprotection runs to January 2035
- Liraglutideprotection runs to January 2037
- Calcitoninno patent or exclusivity listed
Frequently asked questions
When will generic Triptorelin be available?
Based on the patents and exclusivity the FDA lists today, generic triptorelin cannot be marketed in the United States before 2029-06-30, when the last listed protection expires.
Does this date guarantee a generic launches then?
No. It is the date the last protection the FDA currently lists expires. Patents can be challenged, licensed, or designed around, which can bring a generic earlier, and new patents can be listed later. Treat it as the outer limit of the brand's protection, not a launch forecast.
What is the difference between a patent and exclusivity?
A patent is granted by the patent office and listed with the FDA by the brand. Exclusivity is granted by the FDA itself on approval. They run independently, and exclusivity can keep a generic off the market even after a patent has expired.
What is a tentative approval?
It means the FDA has reviewed a generic application and judged it acceptable, but cannot allow it to be marketed yet because patents or exclusivity are still running. It is the clearest signal that a generic is ready to launch once the dates clear.
Source: FDA Orange Book via openFDA, with tentative-approval data from Drugs@FDA. Last updated 2026-11-01. Do not rely on this page to make decisions regarding medical care; always speak to your health provider about the risks and benefits of FDA-regulated products.
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