FDA Orange Book · active-ingredient family
Dalfampridine
Dalfampridine is approved as 1 brand and 8 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:AMPYRA · NDA 022250
1
Brand (NDA)
8
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AMPYRARLD | MERZ | NDA 022250 | AB | Jan 22, 2010 |
Generic (ANDA) products (8)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DALFAMPRIDINE | RISING | ANDA 206858 | — | Jul 06, 2020 | |
| DALFAMPRIDINE | SUN PHARM | ANDA 208292 | — | May 21, 2019 | |
| DALFAMPRIDINE | MICRO LABS | ANDA 210158 | AB | Mar 11, 2019 | |
| DALFAMPRIDINE | HIKMA | ANDA 206646 | — | Oct 24, 2018 | |
| DALFAMPRIDINE | ALKEM LABS LTD | ANDA 206765 | AB | Jul 30, 2018 | |
| DALFAMPRIDINE | ACCORD HLTHCARE | ANDA 206863 | AB | Jul 11, 2018 | |
| DALFAMPRIDINE | ACTAVIS LABS FL INC | ANDA 206836 | AB | Jan 23, 2017 | |
| DALFAMPRIDINE | AUROBINDO PHARMA | ANDA 206811 | AB | Jan 23, 2017 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Dalfampridine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
