FDA Orange Book

Is there a generic for Trelstar?

Trelstar 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 Trelstar (triptorelin). The Orange Book shows its last listed patent expires June 30, 2029.

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Trelstar products in the Orange Book

Trelstar products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
injectable, intramuscularEQ 11.25MG BASE/VIALMarketed (Rx)None0None
injectable, intramuscularEQ 22.5MG BASE/VIALMarketed (Rx)None0None
injectable, intramuscularEQ 3.75MG BASE/VIALMarketed (Rx)None0None

NDA 021288, 022437, 020715, held by VERITY PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Trelstar patents

Patents listed for Trelstar
PatentExpiresCoversUse codeNDA
10166181June 30, 2029Drug productNone022437

Questions

Is there a generic for Trelstar?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Trelstar (triptorelin). The Orange Book shows its last listed patent expires June 30, 2029.

What is the generic name for Trelstar?

The active ingredient in Trelstar is triptorelin, per the FDA Orange Book.

When does the Trelstar patent expire?

The last patent listed for Trelstar 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.

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