Register entry
Emergent BioDefense Operations Lansing, LLC
Data as of · How to read this entry
- Registered sites
- 0
- Active NDC listings
- 5
- Labeller names
- 3
- Live patents
- 6
- Exclusivities
- 1
- Countries
- 0
Catalogue
Drug listings by form and route
55 active NDC listings: 4 human prescription drug, 1 vaccine. By marketing category: BLA 3, NDA 2.
| Dosage form | NDCs |
|---|---|
| injection | 1 |
| injection, powder, lyophilized, for solution | 1 |
| injection, suspension | 1 |
| suspension | 1 |
| tablet, film coated | 1 |
| Route | NDCs |
|---|---|
| intravenous | 2 |
| oral | 2 |
| intramuscular | 1 |
| subcutaneous | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| emergent biodefense operations lansing llc | 3 |
| emergent biodefense operations lansing | 1 |
| emergent biodefense operations lansing, llc | 1 |
Exclusivity
Patents and exclusivities
6| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 9303051 | TEMBEXAbrincidofovir | substance, product | Jul 2034 |
| 10112909 | TEMBEXAbrincidofovir | use | Oct 2034 |
| 10487061 | TEMBEXAbrincidofovir | product | Oct 2034 |
| 8962829 | TEMBEXAbrincidofovir | substance, product | Oct 2034 |
| 9371344 | TEMBEXAbrincidofovir | product | Oct 2034 |
| Product | Exclusivity | Until |
|---|---|---|
| TEMBEXABRINCIDOFOVIR | ODE-354 Orphan drug | Jun 2028 |
Catalogue
Marketed products
5| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| BioThrax | Anthrax Vaccine Adsorbed | injection, suspension, intramuscular, subcutaneous | 64678-211BLA |
| Ebanga | Ansuvimab | injection, powder, lyophilized, for solution, intravenous | 71655-578BLA |
| Raxibacumab | raxibacumab | injection, intravenous | 71655-103BLA |
| Tembexa | Brincidofovir | tablet, film coated, oral | 64678-010NDA |
| Tembexa | Brincidofovir | suspension, oral | 64678-012NDA |
Enquiry
Common questions
- Is Emergent BioDefense Operations Lansing, LLC FDA approved?
- Emergent BioDefense Operations Lansing, LLC holds no registered establishment of its own; 5 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
- What drugs does Emergent BioDefense Operations Lansing, LLC make?
- 5 products are listed under Emergent BioDefense Operations Lansing, LLC in the openFDA NDC Directory, most often as injection; injection, powder, lyophilized, for solution; injection, suspension. 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.