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Home / Generic availability / Triptorelin

FDA Orange Book · updated 2026-09-23

When will generic Triptorelin be available?

Under patent or exclusivity

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.

2029-06-30
Last protection expires
2
Patents listed
0
Exclusivity records
0
Generics waiting

Patents listed with the FDA

2 unexpired or current listing(s).

PatentExpiresCoversProduct
101661812029-06-30drug productTRIPTODUR KIT
101661812029-06-30drug productTRELSTAR

Approved products

ProductTypeApplicantApproved
TRELSTARBrand (NDA)VERITY PHARMACEUTICALS INC2000-06-15reference listed drug, reference standard
TRELSTARBrand (NDA)VERITY PHARMACEUTICALS INC2001-06-29reference listed drug, reference standard
TRELSTARBrand (NDA)VERITY PHARMACEUTICALS INC2010-03-10reference listed drug, reference standard
TRIPTODUR KITBrand (NDA)AZURITY PHARMACEUTICALS INC2017-06-29reference listed drug, reference standard
How to read these dates. They come from the FDA Orange Book, which records the patents a brand has listed and the exclusivity the FDA has granted. The date shown is when the last of those expires. It is an upper bound on protection, not a prediction of when a generic will actually reach pharmacies.

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 2026-09-23. 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.