FDA Orange Book
Is there a generic for Supprelin LA?
Supprelin LA contains histrelin acetate. 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 Supprelin LA (histrelin acetate). The Orange Book shows its last listed patent expires June 16, 2026.
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Supprelin LA products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| implant, subcutaneous | 50MG | Marketed (Rx) | None | 0 | None |
NDA 022058, held by ENDO OPERATIONS LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Supprelin LA patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8062652 | June 16, 2026 | Method of use | U-1197 | 022058 |
Supprelin LA NDC codes
Questions
Is there a generic for Supprelin LA?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Supprelin LA (histrelin acetate). The Orange Book shows its last listed patent expires June 16, 2026.
What is the generic name for Supprelin LA?
The active ingredient in Supprelin LA is histrelin acetate, per the FDA Orange Book.
When does the Supprelin LA patent expire?
The last patent listed for Supprelin LA in the Orange Book expires June 16, 2026. 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.