For multiple sclerosis (MS). Sold as Ampyra. Every FDA application for this active ingredient: 1 branded and 9 generic.
As of Nov 14, 2026, FDA lists 10 applications for Dalfampridine (sold as Ampyra), first approved Jan 22, 2010, with 0 new uses approved and 0 published complete response letters.
| Ampyra | Part D | $39.1M | -3% | 940 |
| Dalfampridine ER | Part D | $38.0M | -22% | 17,843 |
| Jan 22, 2010 | AmpyraNDA 22250 · New molecular entity | Merz | 13 | Marketed |
| Jan 23, 2017 | DalfampridineANDA 206811 | Aurobindo Pharma | 4 | Marketed |
| Jan 23, 2017 | DalfampridineANDA 206836 | Actavis Labs Fl Inc | 3 | Marketed |
| Jul 11, 2018 | DalfampridineANDA 206863 | Accord Hlthcare | 2 | Marketed |
| Jul 30, 2018 | DalfampridineANDA 206765 | Alkem Labs Ltd | 4 | Marketed |
| Oct 24, 2018 | DalfampridineANDA 206646 | Hikma | 3 | Discontinued |
| Mar 11, 2019 | DalfampridineANDA 210158 | Micro Labs | 4 | Marketed |
| May 21, 2019 | DalfampridineANDA 208292 | Sun Pharm | 3 | Discontinued |
| Jul 6, 2020 | DalfampridineANDA 206858 | Rising | 2 | Discontinued |
| — | DalfampridineANDA 206854 | Teva Pharms USA Inc | 0 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Aurobindo Pharma
Accord Hlthcare
Hikma