Register entry
Avadel CNS Pharmaceuticals, LLC
- Registered sites
- 1
- Drug products
- 5
- Live patents
- 113
- 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.
Finished drug manufacture
Sites
Facilities
1| Site | Location | Operations | FEI |
|---|---|---|---|
| Avadel CNS Pharmaceuticals, LLC | Chesterfield, MOUnited States | Finished drug manufacture | 3012841301 |
Exclusivity
Patents
113Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| LUMRYZ | SODIUM OXYBATE | Jul 2037 |
| LUMRYZ | SODIUM OXYBATE | Feb 2042 |
| LUMRYZ | SODIUM OXYBATE | Mar 2042 |
Catalogue
Marketed products
5Showing 5 of 5.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| Lumryz | sodium oxybate | FOR SUSPENSION, EXTENDED RELEASE | NDA |
| Lumryz | sodium oxybate | FOR SUSPENSION, EXTENDED RELEASE | NDA |
| Lumryz | sodium oxybate | FOR SUSPENSION, EXTENDED RELEASE | NDA |
| Lumryz | sodium oxybate | FOR SUSPENSION, EXTENDED RELEASE | NDA |
| Lumryz | sodium oxybate | KIT | 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.