Register entry
Lundbeck Pharmaceuticals LLC
- Registered sites
- 5
- Drug products
- 21
- Live patents
- 7
- Countries
- 4
- Base
- Denmark
Authorisation
Registered operations
What the FDA has registered these sites to do. This is the regulatory record, not a marketing claim.
Analytical testingActive ingredient (API) manufactureLabellingFinished drug manufacturePackaging
Sites
Facilities
5| Site | Location | Operations | FEI |
|---|---|---|---|
| H. Lundbeck A/S | Nykoebing SjDenmark | Active ingredient (API) manufacture | 3002807184 |
| H. Lundbeck A/S | ValbyDenmark | Analytical testing, Finished drug manufacture, Packaging | 3002807185 |
| ELAIAPHARM | ValbonneFrance | Analytical testing, Finished drug manufacture | 3005659648 |
| Lundbeck Pharmaceuticals Italy SpA | PadovaItaly | Active ingredient (API) manufacture | 3002808449 |
| Lundbeck Pharmaceuticals LLC | Deerfield, ILUnited States | Labelling | 3004100593 |
Exclusivity
Patents
7Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| CARNEXIV | CARBAMAZEPINE | Nov 2028 |
| CARNEXIV | CARBAMAZEPINE | Mar 2029 |
| CARNEXIV | CARBAMAZEPINE | Feb 2033 |
| CARNEXIV | CARBAMAZEPINE | Jan 2040 |
Catalogue
Marketed products
21Showing 21 of 21.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| - | Argatroban | POWDER | DRUG FOR FURTHER PROCESSING |
| - | Clomipramine Hydrochloride | POWDER | DRUG FOR FURTHER PROCESSING |
| - | Dapsone | POWDER | DRUG FOR FURTHER PROCESSING |
| - | Desipramine Hydrochloride | POWDER | DRUG FOR FURTHER PROCESSING |
| - | Diazoxide | POWDER | DRUG FOR FURTHER PROCESSING |
| - | Imipramine Pamoate | POWDER | DRUG FOR FURTHER PROCESSING |
| - | Memantine Hydrochloride | POWDER | DRUG FOR FURTHER PROCESSING |
| - | Metoclopramide Hydrochloride | POWDER | DRUG FOR FURTHER PROCESSING |
| Northera | droxidopa | CAPSULE | NDA |
| Northera | droxidopa | CAPSULE | NDA |
| Northera | droxidopa | CAPSULE | NDA |
| Onfi | clobazam | SUSPENSION | NDA |
| Onfi | clobazam | TABLET | NDA |
| Onfi | clobazam | TABLET | NDA |
| SABRIL | vigabatrin | TABLET, FILM COATED | NDA |
| SABRIL | vigabatrin | POWDER, FOR SOLUTION | NDA |
| - | Trimipramine Maleate | POWDER | DRUG FOR FURTHER PROCESSING |
| - | Vortioxetine Hydrobromide | POWDER | DRUG FOR FURTHER PROCESSING |
| Vyepti | eptinezumab-jjmr | INJECTION | BLA |
| Xenazine | tetrabenazine | TABLET | NDA |
| Xenazine | tetrabenazine | TABLET | 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.