FDA Orange Book
Generic for Lupron
Lupron 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
Yes. The generic name for Lupron is leuprolide acetate. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
Run it in Rivvi
Map Lupron and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Lupron products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, subcutaneous | 14MG/2.8ML (1MG/0.2ML) | Discontinued | None | 8 | AP |
NDA 019010, 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.
Approved generic leuprolide acetate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SANDOZ INC | 074728 | AP (A-rated, therapeutically equivalent) | August 4, 1998 | 14MG/2.8ML (1MG/0.2ML) |
| MEITHEAL PHARMACEUTICALS INC | 075471 | AP (A-rated, therapeutically equivalent) | October 25, 2000 | 14MG/2.8ML (1MG/0.2ML) |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 078885 | AP (A-rated, therapeutically equivalent) | March 9, 2009 | 14MG/2.8ML (1MG/0.2ML) |
| SOMERSET THERAPEUTICS LLC | 213829 | AP (A-rated, therapeutically equivalent) | August 13, 2021 | 14MG/2.8ML (1MG/0.2ML) |
| EUGIA PHARMA SPECIALITIES LTD | 212963 | AP (A-rated, therapeutically equivalent) | June 6, 2022 | 14MG/2.8ML (1MG/0.2ML) |
| AMNEAL EU LTD | 215336 | AP (A-rated, therapeutically equivalent) | October 28, 2022 | 14MG/2.8ML (1MG/0.2ML) |
| UBI PHARMA INC | 217957 | AP (A-rated, therapeutically equivalent) | October 17, 2024 | 14MG/2.8ML (1MG/0.2ML) |
| ZYDUS PHARMACEUTICALS USA INC | 215826 | AP (A-rated, therapeutically equivalent) | November 13, 2025 | 14MG/2.8ML (1MG/0.2ML) |
Questions
Is there a generic for Lupron?
Yes. The generic name for Lupron is leuprolide acetate. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Lupron?
The active ingredient in Lupron is leuprolide acetate, per the FDA Orange Book.
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.