Register entry
Swedish Orphan Biovitrum AB (publ)
- Registered sites
- 0
- Drug products
- 15
- Live patents
- 1
- Countries
- 0
- Base
- Unknown
Sites
Facilities
0No registered facilities
This company holds drug listings or approvals but operates no registered establishment of its own, which is normal for an NDA holder that outsources manufacturing.
Exclusivity
Patents
1Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| ORFADIN | NITISINONE | Feb 2033 |
Catalogue
Marketed products
15Showing 15 of 15.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| GAMIFANT | emapalumab-lzsg | INJECTION | BLA |
| GAMIFANT | emapalumab-lzsg | INJECTION | BLA |
| GAMIFANT | emapalumab-lzsg | INJECTION | BLA |
| GAMIFANT | emapalumab-lzsg | INJECTION | BLA |
| GAMIFANT | emapalumab-lzsg | INJECTION | BLA |
| GAMIFANT | emapalumab-lzsg | INJECTION | BLA |
| GAMIFANT | emapalumab-lzsg | INJECTION | BLA |
| KEPIVANCE | palifermin | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | BLA |
| Kineret | anakinra | INJECTION, SOLUTION | BLA |
| ORFADIN | nitisinone | SUSPENSION | NDA |
| Orfadin | Nitisinone | CAPSULE | NDA |
| Orfadin | Nitisinone | CAPSULE | NDA |
| Orfadin | Nitisinone | CAPSULE | NDA |
| Orfadin | Nitisinone | CAPSULE | NDA |
| Synagis | palivizumab | INJECTION, SOLUTION | BLA |
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.