Register entryRepackager / relabeller
Catalyst Pharmaceuticals, Inc.
- Registered sites
- 1
- Drug products
- 9
- Live patents
- 13
- Countries
- 1
- Base
- United States
Authorisation
Registered operations
What the FDA has registered these sites to do. This is the regulatory record, not a marketing claim.
Labelling
Sites
Facilities
1| Site | Location | Operations | FEI |
|---|---|---|---|
| Catalyst Pharmaceuticals, Inc. | Coral Gables, FLUnited States | Labelling | 3010862019 |
Exclusivity
Patents
13Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| AGAMREE | VAMOROLONE | May 2029 |
| AGAMREE | VAMOROLONE | Mar 2033 |
| AGAMREE | VAMOROLONE | Mar 2040 |
| AGAMREE | VAMOROLONE | Jul 2040 |
| FIRDAPSE | AMIFAMPRIDINE PHOSPHATE | Jun 2032 |
| FIRDAPSE | AMIFAMPRIDINE PHOSPHATE | May 2034 |
| FIRDAPSE | AMIFAMPRIDINE PHOSPHATE | Feb 2037 |
Catalogue
Marketed products
9Showing 9 of 9.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| AGAMREE | VAMOROLONE | KIT | NDA |
| Firdapse | amifampridine phosphate | TABLET | NDA |
| Fycompa | perampanel | TABLET | NDA |
| Fycompa | perampanel | TABLET | NDA |
| Fycompa | perampanel | TABLET | NDA |
| Fycompa | perampanel | TABLET | NDA |
| Fycompa | perampanel | TABLET | NDA |
| Fycompa | perampanel | TABLET | NDA |
| Fycompa | perampanel | SUSPENSION | NDA |
Provenance
Facility and operations data from the FDA Drug Establishments Current Registration Site. Product data from the openFDA National Drug Code Directory. Patent and exclusivity data from the FDA Orange Book. Shortage data from the FDA drug shortage database. Contact details the FDA publishes for registered establishments are deliberately not reproduced here. This entry is compiled from public records and has not been claimed by the company.