FDA Orange Book
Is there a generic for Firdapse?
Firdapse contains amifampridine. 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 Firdapse (amifampridine). The Orange Book shows its last listed patent expires February 25, 2037 and its last listed exclusivity ends September 29, 2029.
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Firdapse products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 10MG BASE | Marketed (Rx) | None | 0 | None |
NDA 208078, held by CATALYST PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Firdapse patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11274332 | June 29, 2032 | Method of use | U-2956 | 208078 |
| 11274331 | June 29, 2032 | Method of use | U-2956 | 208078 |
| 11268128 | June 29, 2032 | Method of use | U-2956 | 208078 |
| 11060128 | June 29, 2032 | Method of use | U-2956 | 208078 |
| 10793893 | May 26, 2034 | Method of use | U-2956 | 208078 |
| 10626088 | February 25, 2037 | Drug product | None | 208078 |
Firdapse exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-553 | Orphan drug exclusivity | September 29, 2029 | 208078 |
Firdapse NDC codes
Questions
Is there a generic for Firdapse?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Firdapse (amifampridine). The Orange Book shows its last listed patent expires February 25, 2037 and its last listed exclusivity ends September 29, 2029.
What is the generic name for Firdapse?
The active ingredient in Firdapse is amifampridine, per the FDA Orange Book.
When does the Firdapse patent expire?
The last patent listed for Firdapse in the Orange Book expires February 25, 2037. 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.