Register entry
Biogen International GmbH
- Registered sites
- 3
- Drug products
- 50
- Live patents
- 58
- Countries
- 2
- Base
- United States
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) manufactureFinished drug manufacture
Sites
Facilities
3| Site | Location | Operations | FEI |
|---|---|---|---|
| Biogen International GmbH | LuterbachSwitzerland | Analytical testing, Active ingredient (API) manufacture | 3017081436 |
| Biogen MA Inc. | Morrisville, NCUnited States | Analytical testing, Active ingredient (API) manufacture | 3000719749 |
| Biogen U.S. Corporation | Morrisville, NCUnited States | Analytical testing, Finished drug manufacture | 3010164829 |
Exclusivity
Patents
58Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| SKYCLARYS | OMAVELOXOLONE | Apr 2029 |
| SKYCLARYS | OMAVELOXOLONE | Dec 2029 |
| SKYCLARYS | OMAVELOXOLONE | Apr 2033 |
| SPINRAZA | NUSINERSEN SODIUM | Jul 2027 |
| SPINRAZA | NUSINERSEN SODIUM | Jun 2030 |
| SPINRAZA | NUSINERSEN SODIUM | Nov 2030 |
| SPINRAZA | NUSINERSEN SODIUM | Dec 2030 |
| SPINRAZA | NUSINERSEN SODIUM | Jan 2034 |
| SPINRAZA | NUSINERSEN SODIUM | Sept 2035 |
| SPINRAZA | NUSINERSEN SODIUM | Mar 2036 |
| TECFIDERA | DIMETHYL FUMARATE | Feb 2028 |
| TECFIDERA | DIMETHYL FUMARATE | Mar 2035 |
| TECFIDERA | DIMETHYL FUMARATE | Nov 2035 |
| VUMERITY | DIROXIMEL FUMARATE | Sept 2033 |
| VUMERITY | DIROXIMEL FUMARATE | Oct 2033 |
| ZURZUVAE | ZURANOLONE | Apr 2034 |
| ZURZUVAE | ZURANOLONE | Aug 2037 |
Catalogue
Marketed products
50Showing 50 of 50.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| - | AMIVANTAMAB | LIQUID | BULK INGREDIENT |
| AVONEX | interferon beta-1a | KIT | BLA |
| AVONEX | interferon beta-1a | KIT | BLA |
| Avonex | Interferon Beta-1a | INJECTION, SOLUTION | BLA |
| Avonex Pen | Interferon Beta-1a | INJECTION, SOLUTION | BLA |
| Byooviz | ranibizumab-nuna | INJECTION, SOLUTION | BLA |
| - | EFANESOCTOCOG ALFA | LIQUID | BULK INGREDIENT |
| - | EFANESOCTOCOG ALFA | POWDER, FOR SOLUTION | DRUG FOR FURTHER PROCESSING |
| - | EFANESOCTOCOG ALFA | POWDER, FOR SOLUTION | DRUG FOR FURTHER PROCESSING |
| - | EFANESOCTOCOG ALFA | POWDER, FOR SOLUTION | DRUG FOR FURTHER PROCESSING |
| - | EFANESOCTOCOG ALFA | POWDER, FOR SOLUTION | DRUG FOR FURTHER PROCESSING |
| - | EFANESOCTOCOG ALFA | POWDER, FOR SOLUTION | DRUG FOR FURTHER PROCESSING |
| - | EFANESOCTOCOG ALFA | POWDER, FOR SOLUTION | DRUG FOR FURTHER PROCESSING |
| - | EFMOROCTOCOG ALFA | LIQUID | BULK INGREDIENT |
| - | EFTRENONACOG ALFA | LIQUID | BULK INGREDIENT |
| - | EFTRENONACOG ALFA | POWDER, FOR SUSPENSION | DRUG FOR FURTHER PROCESSING |
| - | EFTRENONACOG ALFA | POWDER, FOR SUSPENSION | DRUG FOR FURTHER PROCESSING |
| - | EFTRENONACOG ALFA | POWDER, FOR SUSPENSION | DRUG FOR FURTHER PROCESSING |
| - | EFTRENONACOG ALFA | POWDER, FOR SUSPENSION | DRUG FOR FURTHER PROCESSING |
| - | EFTRENONACOG ALFA | POWDER, FOR SUSPENSION | DRUG FOR FURTHER PROCESSING |
| - | EFTRENONACOG ALFA | POWDER, FOR SUSPENSION | DRUG FOR FURTHER PROCESSING |
| - | GUSELKUMAB | LIQUID | BULK INGREDIENT |
| - | LECANEMAB | LIQUID | DRUG FOR FURTHER PROCESSING |
| - | Lecanemab | LIQUID | BULK INGREDIENT |
| - | NATALIZUMAB | LIQUID | DRUG FOR FURTHER PROCESSING |
| - | Nusinersen | INJECTION, SOLUTION | DRUG FOR FURTHER PROCESSING |
| - | Nusinersen | INJECTION, SOLUTION | DRUG FOR FURTHER PROCESSING |
| Plegridy | peginterferon beta-1a | INJECTION, SOLUTION | BLA |
| Plegridy | peginterferon beta-1a | KIT | BLA |
| Plegridy | peginterferon beta-1a | INJECTION, SOLUTION | BLA |
| Plegridy Pen | peginterferon beta-1a | INJECTION, SOLUTION | BLA |
| Plegridy Pen | peginterferon beta-1a | KIT | BLA |
| QALSODY | tofersen | INJECTION | NDA |
| SKYCLARYS | omaveloxolone | CAPSULE | NDA |
| Spinraza | Nusinersen | INJECTION, SOLUTION | NDA |
| Spinraza | Nusinersen | INJECTION, SOLUTION | NDA |
| Spinraza | Nusinersen | INJECTION, SOLUTION | NDA |
| TECFIDERA | dimethyl fumarate | CAPSULE | NDA |
| TECFIDERA | dimethyl fumarate | CAPSULE | NDA |
| - | TECLISTAMAB | LIQUID | BULK INGREDIENT |
| TYSABRI | natalizumab | INJECTION | BLA |
| Tecfidera | dimethyl fumarate | KIT | NDA |
| Vumerity | diroximel fumarate | CAPSULE | NDA |
| - | daratumumab | LIQUID | BULK INGREDIENT |
| - | interferon beta-1a | LIQUID | BULK INGREDIENT |
| - | luspatercept | LIQUID | BULK INGREDIENT |
| - | natalizumab | LIQUID | BULK INGREDIENT |
| - | peginterferon beta-1a | LIQUID | BULK INGREDIENT |
| - | sutimlimab | LIQUID | BULK INGREDIENT |
| - | talquetamab | LIQUID | BULK INGREDIENT |
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.