Orange Book product · Brand (NDA)
FIRDAPSE
AMIFAMPRIDINE PHOSPHATE
At a glance
Nov 28, 2018
Approved
Brand (NDA)
Application
Not listed
TE code
6
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 28, 2018
7 yr 8 mo ago
Today
Patent 11060128 expires
Listed method-of-use patent (U-2956) expiration.
Jun 29, 2032
in 6 yr 1 mo
Patent 11268128 expires
Listed method-of-use patent (U-2956) expiration.
Jun 29, 2032
in 6 yr 1 mo
Patent 11274331 expires
Listed method-of-use patent (U-2956) expiration.
Jun 29, 2032
in 6 yr 1 mo
Patent 11274332 expires
Listed method-of-use patent (U-2956) expiration.
Jun 29, 2032
in 6 yr 1 mo
Patent 10793893 expires
Listed method-of-use patent (U-2956) expiration.
May 26, 2034
in 8 yr 1 mo
Patent 10626088 expires
Listed drug product patent expiration.
Feb 25, 2037
in 10 yr 10 mo
Pharmaceutical detail
Active ingredient
AMIFAMPRIDINE PHOSPHATE
Strength
EQ 10MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 208078
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11060128 | Jun 29, 2032 | in 6 yr 1 mo | U-2956 |
| 11268128 | Jun 29, 2032 | in 6 yr 1 mo | U-2956 |
| 11274331 | Jun 29, 2032 | in 6 yr 1 mo | U-2956 |
| 11274332 | 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 |
