Register entry
Alexion Pharmaceuticals, Inc.
- Registered sites
- 3
- Drug products
- 10
- Live patents
- 4
- Countries
- 2
- Base
- Ireland
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
3| Site | Location | Operations | FEI |
|---|---|---|---|
| Alexion Pharma International Operations Limited | AthloneIreland | Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture | 3011532960 |
| Alexion Pharma International Operations Limited | DublinIreland | Analytical testing, Active ingredient (API) manufacture, Labelling, Packaging | 3012889718 |
| Alexion Pharmaceuticals Inc. | Bogart, GAUnited States | Analytical testing, Finished drug manufacture | 3011263308 |
Exclusivity
Patents
4Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| VOYDEYA | DANICOPAN | Feb 2035 |
| VOYDEYA | DANICOPAN | Aug 2038 |
Catalogue
Marketed products
10Showing 10 of 10.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| SOLIRIS | ECULIZUMAB | INJECTION, SOLUTION, CONCENTRATE | BLA |
| STRENSIQ | ASFOTASE ALFA | SOLUTION | BLA |
| STRENSIQ | ASFOTASE ALFA | SOLUTION | BLA |
| STRENSIQ | ASFOTASE ALFA | SOLUTION | BLA |
| STRENSIQ | ASFOTASE ALFA | SOLUTION | BLA |
| Ultomiris | ravulizumab | SOLUTION, CONCENTRATE | BLA |
| Ultomiris | ravulizumab | SOLUTION, CONCENTRATE | BLA |
| Ultomiris | ravulizumab | SOLUTION, CONCENTRATE | BLA |
| Voydeya | Danicopan | TABLET, FILM COATED | NDA |
| Voydeya | Danicopan | 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.