FDA Orange Book
Is there a generic for Lupron Depot-ped Kit?
Lupron Depot-ped Kit 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-ped Kit (leuprolide acetate). The Orange Book shows its last listed patent expires February 5, 2031 and its last listed exclusivity ends April 14, 2026.
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Lupron Depot-ped Kit products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, intramuscular | 11.25MG | Marketed (Rx) | None | 0 | None |
| powder, intramuscular | 11.25MG | Marketed (Rx) | None | 0 | None |
| powder, intramuscular | 15MG | Marketed (Rx) | None | 0 | None |
| powder, intramuscular | 3.75MG,7.5MG | Discontinued | None | 0 | None |
| powder, intramuscular | 30MG | Marketed (Rx) | None | 0 | None |
| powder, intramuscular | 45MG | Marketed (Rx) | None | 0 | None |
| powder, intramuscular | 7.5MG | Marketed (Rx) | None | 0 | None |
| powder, intramuscular | 7.5MG,7.5MG | Discontinued | None | 0 | None |
NDA 020263, 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-ped Kit patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9617303 | March 22, 2028 | Method of use | U-3611 | 020263 |
| 8921326 | February 5, 2031 | Drug product | None | 020263 |
Lupron Depot-ped Kit exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NS | New strength | April 14, 2026 | 020263 |
Questions
Is there a generic for Lupron Depot-ped Kit?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Lupron Depot-ped Kit (leuprolide acetate). The Orange Book shows its last listed patent expires February 5, 2031 and its last listed exclusivity ends April 14, 2026.
What is the generic name for Lupron Depot-ped Kit?
The active ingredient in Lupron Depot-ped Kit is leuprolide acetate, per the FDA Orange Book.
When does the Lupron Depot-ped Kit patent expire?
The last patent listed for Lupron Depot-ped Kit 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.