Register entryRepackager / relabeller
- Registered sites
- 1
- Active NDC listings
- 9
- Live patents
- 13
- Exclusivities
- 2
- Countries
- 1
- Base
- United States
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Catalyst Pharmaceuticals, Inc. | 355 Alhambra Cir Ste 801, Coral Gables, Florida (FL) 33134-5038, United States (USA) | Labelling | 3010862019053742248 |
Catalogue
Drug listings by form and route
99 active NDC listings: 9 human prescription drug. By marketing category: NDA 9.
| Dosage form | NDCs |
|---|---|
| tablet | 7 |
| kit | 1 |
| suspension | 1 |
| Route | NDCs |
|---|---|
| oral | 9 |
| Labeller name on the listing | NDCs |
|---|---|
| catalyst pharmaceuticals, inc. | 9 |
Exclusivity
Patents and exclusivities
13| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 10857161 | AGAMREEvamorolone | product | May 2029 |
| 11833159 | AGAMREEvamorolone | product | May 2029 |
| 8334279 | AGAMREEvamorolone | use | May 2029 |
| 11060128 | FIRDAPSEamifampridine phosphate | use | Jun 2032 |
| 11268128 | FIRDAPSEamifampridine phosphate | use | Jun 2032 |
| 11274331 | FIRDAPSEamifampridine phosphate | use | Jun 2032 |
| 11274332 | FIRDAPSEamifampridine phosphate | use | Jun 2032 |
| 11690853 | AGAMREEvamorolone | use | Mar 2033 |
| 10793893 | FIRDAPSEamifampridine phosphate | use | May 2034 |
| 10626088 | FIRDAPSEamifampridine phosphate | product | Feb 2037 |
| 11471471 | AGAMREEvamorolone | use | Mar 2040 |
| 12201639 | AGAMREEvamorolone | substance, product | Mar 2040 |
| 11382922 | AGAMREEvamorolone | substance, product | Jul 2040 |
| Product | Exclusivity | Until |
|---|---|---|
| AGAMREEVAMOROLONE | ODE-450 Orphan drug | Oct 2030 |
| FIRDAPSEAMIFAMPRIDINE PHOSPHATE | ODE-553 Orphan drug | Sept 2029 |
Catalogue
Marketed products
9| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| AGAMREE | VAMOROLONE | kit, oral | 69616-264NDA |
| Firdapse | amifampridine phosphate | tablet, oral | 69616-211NDA |
| Fycompa | perampanel | tablet, oral | 69616-272NDA |
| Fycompa | perampanel | tablet, oral | 69616-274NDA |
| Fycompa | perampanel | tablet, oral | 69616-276NDA |
| Fycompa | perampanel | tablet, oral | 69616-278NDA |
| Fycompa | perampanel | tablet, oral | 69616-280NDA |
| Fycompa | perampanel | tablet, oral | 69616-282NDA |
| Fycompa | perampanel | suspension, oral | 69616-290NDA |
Compare
Comparable companies in United States
- Bryant Ranch Prepack1 site · 4,357 NDC
- Proficient Rx LP1 site · 1,729 NDC
- RemedyRepack, Inc1 site · 1,521 NDC
- Preferred Pharmaceuticals Inc.1 site · 1,046 NDC
- PD-Rx Pharmaceuticals Inc.1 site · 828 NDC
- Northwind Health Company, LLC1 site · 580 NDC
- Direct Rx1 site · 554 NDC
- Professional Compounding Centers of America dba PCCA1 site · 487 NDC
- Shiseido Americas Corporation1 site · 361 NDC
- Actavis LLC1 site · 309 NDC
Enquiry
Common questions
- Is Catalyst Pharmaceuticals, Inc. FDA approved?
- Catalyst Pharmaceuticals, Inc. holds 1 FDA-registered establishment in the United States. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
- Where are Catalyst Pharmaceuticals, Inc.'s registered sites?
- The FDA register lists Coral Gables, FL. Registered operations: labelling.
- What drugs does Catalyst Pharmaceuticals, Inc. make?
- 9 products are listed under Catalyst Pharmaceuticals, Inc. in the openFDA NDC Directory, most often as tablet; kit; suspension. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.