Register entry
- Registered sites
- 0
- Active NDC listings
- 2
- Live patents
- 14
- Exclusivities
- 1
- Countries
- 0
Catalogue
Drug listings by form and route
22 active NDC listings: 2 human prescription drug. By marketing category: NDA 2.
| Dosage form | NDCs |
|---|---|
| injection | 1 |
| injection, solution | 1 |
| Route | NDCs |
|---|---|
| intravenous | 2 |
| Labeller name on the listing | NDCs |
|---|---|
| blue earth diagnostics | 2 |
Exclusivity
Patents and exclusivities
14| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 10010632 | AXUMINfluciclovine f-18 | product | Nov 2026 |
| 10953112 | AXUMINfluciclovine f-18 | use | Nov 2026 |
| 9387266 | AXUMINfluciclovine f-18 | use | Nov 2026 |
| 10124079 | AXUMINfluciclovine f-18 | use | Dec 2035 |
| 10716868 | AXUMINfluciclovine f-18 | use | Dec 2035 |
| 10933147 | AXUMINfluciclovine f-18 | use | Dec 2035 |
| 10967077 | AXUMINfluciclovine f-18 | use | Dec 2035 |
| 12390540 | POSLUMAflotufolastat f-18 gallium | substance | Aug 2038 |
| 11413360 | POSLUMAflotufolastat f-18 gallium | substance | Nov 2038 |
| 12357711 | POSLUMAflotufolastat f-18 gallium | substance | Nov 2038 |
| 12377176 | POSLUMAflotufolastat f-18 gallium | substance | Nov 2038 |
| 12036290 | POSLUMAflotufolastat f-18 gallium | product | Nov 2041 |
| 12427207 | POSLUMAflotufolastat f-18 gallium | product | Nov 2041 |
| 11980674 | AXUMINfluciclovine f-18 | use | Apr 2042 |
| Product | Exclusivity | Until |
|---|---|---|
| POSLUMAFLOTUFOLASTAT F-18 GALLIUM | NCE New chemical entity | May 2028 |
Catalogue
Marketed products
2| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| Axumin | Fluciclovine F-18 | injection, solution, intravenous | 69932-001NDA |
| POSLUMA | flotufolastat F-18 | injection, intravenous | 69932-002NDA |
Enquiry
Common questions
- Is Blue Earth Diagnostics FDA approved?
- Blue Earth Diagnostics holds no registered establishment of its own; 2 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
- What drugs does Blue Earth Diagnostics make?
- 2 products are listed under Blue Earth Diagnostics in the openFDA NDC Directory, most often as injection; injection, 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.