Amifampridine - Generic Drug Details
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Summary for amifampridine
| US Patents: | 2 |
| Tradenames: | 2 |
| Applicants: | 2 |
| NDAs: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 162 |
| Clinical Trials: | 9 |
| Patent Applications: | 5,685 |
| What excipients (inactive ingredients) are in amifampridine? | amifampridine excipients list |
| DailyMed Link: | amifampridine at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for amifampridine
Generic Entry Date for amifampridine*:
Constraining patent/regulatory exclusivity:
TREATMENT OF LAMBERT-EATON MYASTHENIC SYNDROME (LEMS) IN PATIENTS 6 TO LESS THAN 17 YEARS OF AGE Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for amifampridine
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Wake Forest University Health Sciences | Phase 1 |
| Augusta University | Phase 2 |
| Catalyst Pharmaceuticals, Inc. | Phase 2 |
Generic filers with tentative approvals for AMIFAMPRIDINE
| Applicant | Application No. | Strength | Dosage Form |
| ⤷ Try a Trial | ⤷ Try a Trial | 10MG | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
