FDA Orange Book · active-ingredient family
Amifampridine phosphate
Amifampridine phosphate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:FIRDAPSE · NDA 208078
1
Brand (NDA)
0
Generics (ANDA)
6
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FIRDAPSERLD | CATALYST PHARMS | NDA 208078 | — | Nov 28, 2018 |
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11274332 | Jun 29, 2032 | in 6 yr 1 mo | U-2956 |
| 11274331 | Jun 29, 2032 | in 6 yr 1 mo | U-2956 |
| 11268128 | Jun 29, 2032 | in 6 yr 1 mo | U-2956 |
| 11060128 | Jun 29, 2032 | in 6 yr 1 mo | U-2956 |
| 10793893 | May 26, 2034 | in 8 yr 1 mo | U-2956 |
| 10626088 | Feb 25, 2037 | in 10 yr 10 mo | Product |
Amifampridine phosphate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
