FDA Orange Book
Is there a generic for Firmagon?
Firmagon contains degarelix 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 Firmagon (degarelix acetate). The Orange Book shows its last listed patent expires April 27, 2032.
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Firmagon products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, subcutaneous | EQ 120MG BASE/VIAL | Marketed (Rx) | None | 0 | None |
| powder, subcutaneous | EQ 80MG BASE/VIAL | Marketed (Rx) | None | 0 | None |
NDA 022201, held by FERRING PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Firmagon patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9579359 | February 10, 2029 | Method of use | U-1978 | 022201 |
| 10973870 | February 10, 2029 | Method of use | U-1978 | 022201 |
| 10729739 | February 10, 2029 | Method of use | U-1978 | 022201 |
| 12514898 | February 20, 2029 | Method of use | U-1978 | 022201 |
| 12533387 | February 20, 2029 | Method of use | U-4417 | 022201 |
| 10695398 | April 27, 2032 | Method of use | U-1895 | 022201 |
| 9415085 | April 27, 2032 | Method of use | U-1895 | 022201 |
| 11766468 | April 27, 2032 | Method of use | U-1978 | 022201 |
| 11826397 | April 27, 2032 | Method of use | U-1978 | 022201 |
Questions
Is there a generic for Firmagon?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Firmagon (degarelix acetate). The Orange Book shows its last listed patent expires April 27, 2032.
What is the generic name for Firmagon?
The active ingredient in Firmagon is degarelix acetate, per the FDA Orange Book.
When does the Firmagon patent expire?
The last patent listed for Firmagon in the Orange Book expires April 27, 2032. 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.