FDA Orange Book
Is there a generic for Triptodur Kit?
Triptodur Kit contains triptorelin. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Triptodur Kit (triptorelin). The Orange Book shows its last listed patent expires June 30, 2029.
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Triptodur Kit products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| for suspension, extended release, intramuscular | EQ 22.5MG BASE/VIAL | Marketed (Rx) | None | 0 | None |
NDA 208956, held by AZURITY PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Triptodur Kit patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10166181 | June 30, 2029 | Drug product | None | 208956 |
Questions
Is there a generic for Triptodur Kit?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Triptodur Kit (triptorelin). The Orange Book shows its last listed patent expires June 30, 2029.
What is the generic name for Triptodur Kit?
The active ingredient in Triptodur Kit is triptorelin, per the FDA Orange Book.
When does the Triptodur Kit patent expire?
The last patent listed for Triptodur Kit in the Orange Book expires June 30, 2029. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.