Register entryRepackager / relabeller
- Registered sites
- 1
- Active NDC listings
- 1
- Live patents
- 6
- Exclusivities
- 1
- Countries
- 1
- Base
- United States
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Stealth BioTherapeutics Inc.Registrant: Stealth Biotherapeutics Inc. | 123 Highland Avenue, Suite 201, Needham, Massachusetts (MA) 02494, United States (USA) | Labelling | 3030795113963920215 |
Exclusivity
Patents and exclusivities
6| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 7576061 | FORZINITYelamipretide hydrochloride | substance, product | Jan 2027 |
| 11083771 | FORZINITYelamipretide hydrochloride | use | Feb 2034 |
| 11083772 | FORZINITYelamipretide hydrochloride | use | Feb 2034 |
| 11771734 | FORZINITYelamipretide hydrochloride | use | Feb 2034 |
| 12268724 | FORZINITYelamipretide hydrochloride | use | Feb 2034 |
| 9687519 | FORZINITYelamipretide hydrochloride | use | Feb 2034 |
| Product | Exclusivity | Until |
|---|---|---|
| FORZINITYELAMIPRETIDE HYDROCHLORIDE | ODE-551 Orphan drug | Sept 2032 |
Catalogue
Marketed products
1| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| FORZINITY | Elamipretide Hydrochloride | injection, subcutaneous | 72507-800NDA |
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Enquiry
Common questions
- Is Stealth Biotherapeutics Inc. FDA approved?
- Stealth Biotherapeutics Inc. holds 1 FDA-registered establishment in the United States. 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 Stealth Biotherapeutics Inc.'s registered sites?
- The FDA register lists Needham, MA. Registered operations: labelling.
- What drugs does Stealth Biotherapeutics Inc. make?
- 1 product is listed under Stealth Biotherapeutics Inc. in the openFDA NDC Directory, most often as injection. 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.