Register entry
- Registered sites
- 0
- Active NDC listings
- 1
- Live patents
- 5
- Exclusivities
- 1
- Countries
- 0
Exclusivity
Patents and exclusivities
5| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 7795243 | ORLYNVAHprobenecid; sulopenem etzadroxil | substance, product | Jun 2029 |
| 11554112 | ORLYNVAHprobenecid; sulopenem etzadroxil | use | Apr 2039 |
| 12109197 | ORLYNVAHprobenecid; sulopenem etzadroxil | use | Apr 2039 |
| 11478428 | ORLYNVAHprobenecid; sulopenem etzadroxil | product | Dec 2039 |
| 12544337 | ORLYNVAHprobenecid; sulopenem etzadroxil | product | Dec 2039 |
| Product | Exclusivity | Until |
|---|---|---|
| ORLYNVAHPROBENECID; SULOPENEM ETZADROXIL | GAIN Qualified infectious disease product (GAIN) | Oct 2034 |
Catalogue
Marketed products
1| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| ORLYNVAH | sulopenem etzadroxil and probenecid | tablet, film coated, oral | 81153-100NDA |
Enquiry
Common questions
- Is ITERUM THERAPEUTICS US LIMITED FDA approved?
- ITERUM THERAPEUTICS US LIMITED holds no registered establishment of its own; 1 drug product is listed under its name in the National Drug Code Directory, made at sites registered to other firms.
- What drugs does ITERUM THERAPEUTICS US LIMITED make?
- 1 product is listed under ITERUM THERAPEUTICS US LIMITED in the openFDA NDC Directory, most often as tablet, film coated. 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.