Register entry
- Registered sites
- 0
- Active NDC listings
- 3
- Labeller names
- 2
- Live patents
- 11
- Exclusivities
- 1
- Countries
- 0
Catalogue
Drug listings by form and route
33 active NDC listings: 3 human prescription drug. By marketing category: BLA 2, NDA 1.
| Dosage form | NDCs |
|---|---|
| injection | 2 |
| suspension | 1 |
| Route | NDCs |
|---|---|
| intravenous | 2 |
| subcutaneous | 2 |
| oral | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| immedica pharma us inc. | 2 |
| immedica pharma us inc | 1 |
Exclusivity
Patents and exclusivities
11| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 7858609 | ZTALMYganaxolone | product | Nov 2026 |
| 8022054 | ZTALMYganaxolone | product | Nov 2026 |
| 8367651 | ZTALMYganaxolone | product | Nov 2026 |
| 8618087 | ZTALMYganaxolone | use | Nov 2026 |
| 9029355 | ZTALMYganaxolone | product | Nov 2026 |
| 9056116 | ZTALMYganaxolone | use | Nov 2026 |
| 8318714 | ZTALMYganaxolone | product | Nov 2031 |
| 10603308 | ZTALMYganaxolone | use | Aug 2037 |
| 12144801 | ZTALMYganaxolone | use | Aug 2037 |
| 12115169 | ZTALMYganaxolone | use | Sept 2042 |
| 12268696 | ZTALMYganaxolone | use | Sept 2042 |
| Product | Exclusivity | Until |
|---|---|---|
| ZTALMYGANAXOLONE | ODE-395 Orphan drug | Jun 2029 |
Catalogue
Marketed products
3| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| Loargys | pegzilarginase-nbln | injection, intravenous, subcutaneous | 81583-102BLA |
| Loargys | pegzilarginase-nbln | injection, intravenous, subcutaneous | 81583-105BLA |
| ZTALMY | ganaxolone | suspension, oral | 81583-100NDA |
Enquiry
Common questions
- Is Immedica Pharma US Inc. FDA approved?
- Immedica Pharma US Inc. holds no registered establishment of its own; 3 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
- What drugs does Immedica Pharma US Inc. make?
- 3 products are listed under Immedica Pharma US Inc. in the openFDA NDC Directory, most often as 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.