FDA Orange Book
Generic for Cetrotide
Cetrotide contains cetrorelix 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 Cetrotide is cetrorelix acetate. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 1 of the 2 Cetrotide products the Orange Book lists.
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Cetrotide products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, subcutaneous | EQ 0.25MG BASE/VIAL | Marketed (Rx) | AP | 5 | AP |
| powder, subcutaneous | EQ 3MG BASE/VIAL | Discontinued | None | 0 | None |
NDA 021197, held by EMD SERONO INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic cetrorelix acetate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| QILU PHARMACEUTICAL CO LTD | 217776 | AP (A-rated, therapeutically equivalent) | April 16, 2024 | EQ 0.25MG BASE/VIAL |
| LIVZON GROUP PHARMACEUTICAL FACTORY | 214540 | AP (A-rated, therapeutically equivalent) | April 24, 2024 | EQ 0.25MG BASE/VIAL |
| GLAND PHARMA LTD | 218150 | AP (A-rated, therapeutically equivalent) | April 25, 2024 | EQ 0.25MG BASE/VIAL |
| XIROMED PHARMA ESPANA SL | 218061 | AP (A-rated, therapeutically equivalent) | June 3, 2025 | EQ 0.25MG BASE/VIAL |
| EPIC PHARMA LLC | 218740 | AP (A-rated, therapeutically equivalent) | April 29, 2026 | EQ 0.25MG BASE/VIAL |
Questions
Is there a generic for Cetrotide?
Yes. The generic name for Cetrotide is cetrorelix acetate. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 1 of the 2 Cetrotide products the Orange Book lists.
What is the generic name for Cetrotide?
The active ingredient in Cetrotide is cetrorelix 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.