Register entry
- Registered sites
- 3
- Active NDC listings
- 50
- Labeller names
- 3
- Live patents
- 58
- Exclusivities
- 3
- Countries
- 2
- Base
- United States
Authorisation
Registered operations
Analytical testing3Active ingredient (API) manufacture2Finished drug manufacture1
Sites
Registered establishments
3| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Biogen International GmbH | Attisholzstrasse 11, Luterbach, Solothurn CH-4542, Switzerland (CHE) | Analytical testing, Active ingredient (API) manufacture | 3017081436480114999 |
| Biogen MA Inc.Registrant: Biogen Inc. | 5000 Davis Drive, Morrisville, North Carolina (NC) 27560, United States (USA) | Analytical testing, Active ingredient (API) manufacture | 3000719749841087823 |
| Biogen U.S. CorporationRegistrant: Biogen Inc. | 900 Davis Drive, Morrisville, North Carolina (NC) 27560, United States (USA) | Analytical testing, Finished drug manufacture | 3010164829078734950 |
Catalogue
Drug listings by form and route
5050 active NDC listings: 20 human prescription drug, 16 drug for further processing, 14 bulk ingredient. By marketing category: DRUG FOR FURTHER PROCESSING 16, BULK INGREDIENT 14, BLA 11, NDA 9.
| Dosage form | NDCs |
|---|---|
| liquid | 16 |
| injection, solution | 11 |
| powder, for solution | 6 |
| powder, for suspension | 6 |
| kit | 5 |
| capsule | 4 |
| injection | 2 |
| Route | NDCs |
|---|---|
| intramuscular | 5 |
| intrathecal | 4 |
| oral | 4 |
| subcutaneous | 4 |
| intravenous | 1 |
| intravitreal | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| biogen inc. | 46 |
| biogen | 3 |
| biogen inc. | 1 |
Exclusivity
Patents and exclusivities
58| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 7838657 | SPINRAZAnusinersen sodium | substance, product | Jul 2027 |
| 8399514 | TECFIDERAdimethyl fumarate | use | Feb 2028 |
| 11091430 | SKYCLARYSomaveloxolone | use | Apr 2029 |
| 11919838 | SKYCLARYSomaveloxolone | use | Apr 2029 |
| 8440854 | SKYCLARYSomaveloxolone | product | Apr 2029 |
| 9670147 | SKYCLARYSomaveloxolone | substance | Apr 2029 |
| 8124799 | SKYCLARYSomaveloxolone | substance | Dec 2029 |
| 9717750 | SPINRAZAnusinersen sodium | use | Jun 2030 |
| 8980853 | SPINRAZAnusinersen sodium | use | Nov 2030 |
| 8361977 | SPINRAZAnusinersen sodium | substance, product | Dec 2030 |
| 8993640 | SKYCLARYSomaveloxolone | substance, product | Apr 2033 |
| 9701709 | SKYCLARYSomaveloxolone | substance, product | Apr 2033 |
| 10080733 | VUMERITYdiroximel fumarate | substance, product | Sept 2033 |
| 9090558 | VUMERITYdiroximel fumarate | use | Sept 2033 |
| 8669281 | VUMERITYdiroximel fumarate | substance, product | Oct 2033 |
| 9926559 | SPINRAZAnusinersen sodium | use | Jan 2034 |
| 10172871 | ZURZUVAEzuranolone | use | Apr 2034 |
| 10342810 | ZURZUVAEzuranolone | use | Apr 2034 |
| 9512165 | ZURZUVAEzuranolone | substance, product | Apr 2034 |
| 10391160 | TECFIDERAdimethyl fumarate | use | Mar 2035 |
| 10555993 | TECFIDERAdimethyl fumarate | use | Mar 2035 |
| 10994003 | TECFIDERAdimethyl fumarate | use | Mar 2035 |
| 10436802 | SPINRAZAnusinersen sodium | use | Sept 2035 |
| 10959972 | TECFIDERAdimethyl fumarate | use | Nov 2035 |
| 11007166 | TECFIDERAdimethyl fumarate | use | Nov 2035 |
| 11007167 | TECFIDERAdimethyl fumarate | use | Nov 2035 |
| 11129806 | TECFIDERAdimethyl fumarate | use | Nov 2035 |
| 11246850 | TECFIDERAdimethyl fumarate | use | Nov 2035 |
| 12013403 | SPINRAZAnusinersen sodium | use | Mar 2036 |
| 11236121 | ZURZUVAEzuranolone | substance | Aug 2037 |
| 11884696 | ZURZUVAEzuranolone | use | Aug 2037 |
| Product | Exclusivity | Until |
|---|---|---|
| SKYCLARYSOMAVELOXOLONE | ODE-427 Orphan drug | Feb 2030 |
| SPINRAZANUSINERSEN SODIUM | NS New strength | Mar 2029 |
| ZURZUVAEZURANOLONE | NCE New chemical entity | Oct 2028 |
Catalogue
Marketed products
50| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| - | AMIVANTAMAB | liquid | 64406-590BULK INGREDIENT |
| AVONEX | interferon beta-1a | kit, intramuscular | 59627-222BLA |
| AVONEX | interferon beta-1a | kit, intramuscular | 59627-333BLA |
| Avonex | Interferon Beta-1a | injection, solution, intramuscular | 59627-002BLA |
| Avonex Pen | Interferon Beta-1a | injection, solution, intramuscular | 59627-003BLA |
| Byooviz | ranibizumab-nuna | injection, solution, intravitreal | 64406-019BLA |
| - | EFANESOCTOCOG ALFA | liquid | 64406-530BULK INGREDIENT |
| - | EFANESOCTOCOG ALFA | powder, for solution | 64406-710DRUG FOR FURTHER PROCESSING |
| - | EFANESOCTOCOG ALFA | powder, for solution | 64406-711DRUG FOR FURTHER PROCESSING |
| - | EFANESOCTOCOG ALFA | powder, for solution | 64406-712DRUG FOR FURTHER PROCESSING |
| - | EFANESOCTOCOG ALFA | powder, for solution | 64406-713DRUG FOR FURTHER PROCESSING |
| - | EFANESOCTOCOG ALFA | powder, for solution | 64406-714DRUG FOR FURTHER PROCESSING |
| - | EFANESOCTOCOG ALFA | powder, for solution | 64406-715DRUG FOR FURTHER PROCESSING |
| - | EFMOROCTOCOG ALFA | liquid | 64406-500BULK INGREDIENT |
| - | EFTRENONACOG ALFA | liquid | 64406-570BULK INGREDIENT |
| - | EFTRENONACOG ALFA | powder, for suspension | 64406-700DRUG FOR FURTHER PROCESSING |
| - | EFTRENONACOG ALFA | powder, for suspension | 64406-701DRUG FOR FURTHER PROCESSING |
| - | EFTRENONACOG ALFA | powder, for suspension | 64406-702DRUG FOR FURTHER PROCESSING |
| - | EFTRENONACOG ALFA | powder, for suspension | 64406-703DRUG FOR FURTHER PROCESSING |
| - | EFTRENONACOG ALFA | powder, for suspension | 64406-704DRUG FOR FURTHER PROCESSING |
| - | EFTRENONACOG ALFA | powder, for suspension | 64406-705DRUG FOR FURTHER PROCESSING |
| - | GUSELKUMAB | liquid | 64406-560BULK INGREDIENT |
| - | LECANEMAB | liquid | 64406-330DRUG FOR FURTHER PROCESSING |
| - | Lecanemab | liquid | 64406-200BULK INGREDIENT |
| - | NATALIZUMAB | liquid | 64406-320DRUG FOR FURTHER PROCESSING |
| - | Nusinersen | injection, solution | 64406-310DRUG FOR FURTHER PROCESSING |
| - | Nusinersen | injection, solution | 64406-311DRUG FOR FURTHER PROCESSING |
| Plegridy | peginterferon beta-1a | injection, solution, subcutaneous | 64406-015BLA |
| Plegridy | peginterferon beta-1a | kit, subcutaneous | 64406-016BLA |
| Plegridy | peginterferon beta-1a | injection, solution, intramuscular | 64406-017BLA |
| Plegridy Pen | peginterferon beta-1a | injection, solution, subcutaneous | 64406-011BLA |
| Plegridy Pen | peginterferon beta-1a | kit, subcutaneous | 64406-012BLA |
| QALSODY | tofersen | injection, intrathecal | 64406-109NDA |
| SKYCLARYS | omaveloxolone | capsule, oral | 64406-250NDA |
| Spinraza | Nusinersen | injection, solution, intrathecal | 64406-036NDA |
| Spinraza | Nusinersen | injection, solution, intrathecal | 64406-037NDA |
| Spinraza | Nusinersen | injection, solution, intrathecal | 64406-058NDA |
| TECFIDERA | dimethyl fumarate | capsule, oral | 64406-005NDA |
| TECFIDERA | dimethyl fumarate | capsule, oral | 64406-006NDA |
| - | TECLISTAMAB | liquid | 64406-580BULK INGREDIENT |
| TYSABRI | natalizumab | injection, intravenous | 64406-008BLA |
| Tecfidera | dimethyl fumarate | kit | 64406-007NDA |
| Vumerity | diroximel fumarate | capsule, oral | 64406-020NDA |
| - | daratumumab | liquid | 64406-520BULK INGREDIENT |
| - | interferon beta-1a | liquid | 64406-210BULK INGREDIENT |
| - | luspatercept | liquid | 64406-550BULK INGREDIENT |
| - | natalizumab | liquid | 64406-120BULK INGREDIENT |
| - | peginterferon beta-1a | liquid | 64406-125BULK INGREDIENT |
| - | sutimlimab | liquid | 64406-510BULK INGREDIENT |
| - | talquetamab | liquid | 64406-540BULK INGREDIENT |
Neighbours
Registered in the same town
9- BioAgilytix Labs, LLCMorrisville, NC · 2 sites
- Catalent Pharma Solutions Inc.Morrisville, NC
- Alcami Carolinas CorporationMorrisville, NC
- Exel Inc. dba DHL Supply Chain (USA)Morrisville, NC
- Solvias North America, LLCMorrisville, NC
- Pace Analytical Life Sciences, LLCMorrisville, NC
- United Therapeutics CorporationMorrisville, NC
- Boston Analytical Inc. dba. BA SciencesMorrisville, NC
- Liquidia CorporationMorrisville, NC
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Enquiry
Common questions
- Is Biogen International GmbH FDA approved?
- Biogen International GmbH holds 3 FDA-registered establishments across 2 countries. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
- Where are Biogen International GmbH's drugs manufactured?
- At registered sites in Switzerland, the United States. The FDA register lists Luterbach; Morrisville, NC. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture.
- What drugs does Biogen International GmbH make?
- 50 products are listed under Biogen International GmbH in the openFDA NDC Directory, most often as liquid; injection, solution; powder, for solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.