FDA Orange Book
Is there a generic for Lupron Depot?
Lupron Depot contains leuprolide 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 Lupron Depot (leuprolide acetate). The Orange Book shows its last listed patent expires February 5, 2031.
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Lupron Depot products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 11.25MG | Marketed (Rx) | None | 0 | None |
| injectable, injection | 22.5MG | Marketed (Rx) | None | 0 | None |
| injectable, injection | 3.75MG | Marketed (Rx) | None | 0 | None |
| injectable, injection | 3.75MG/VIAL | Discontinued | None | 0 | None |
| injectable, injection | 30MG | Marketed (Rx) | None | 0 | None |
| injectable, injection | 45MG | Marketed (Rx) | None | 0 | None |
| injectable, injection | 7.5MG | Marketed (Rx) | None | 0 | None |
NDA 020708, 020517, 020011, 019732, held by ABBVIE ENDOCRINE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Lupron Depot patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9617303 | March 22, 2028 | Method of use | U-4001 | 020517 |
| 8921326 | February 5, 2031 | Drug product | U-1666 | 020517 |
Questions
Is there a generic for Lupron Depot?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Lupron Depot (leuprolide acetate). The Orange Book shows its last listed patent expires February 5, 2031.
What is the generic name for Lupron Depot?
The active ingredient in Lupron Depot is leuprolide acetate, per the FDA Orange Book.
When does the Lupron Depot patent expire?
The last patent listed for Lupron Depot in the Orange Book expires February 5, 2031. 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.