elamipretide hydrochloride · Stealth Biotheraps · NDA 215244
Forzinity
Earliest generic entry, as listed
28 Feb 2034
Blocked by patent: US 11083771, US 11083772, US 11771734, US 12268724, US 9687519. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 6 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11083771 | use U-4277 | 28 Feb 2034 |
| US 11083772 | use U-4277 | 28 Feb 2034 |
| US 11771734 | use U-4277 | 28 Feb 2034 |
| US 12268724 | use U-4277 | 28 Feb 2034 |
| US 9687519 | use U-4277 | 28 Feb 2034 |
| US 7576061 | substance, product | 20 Jan 2027 |
Exclusivities · 2 unexpired
| ODE-551 | orphan drug (7 years) | 19 Sep 2032 |
| NCE | new chemical entity (5 years) | 19 Sep 2030 |
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 215244 · 001 · RLD | solution, subcutaneous | EQ 280MG BASE/3.5ML (EQ 80MG BASE/ML) | 28 Feb 2034 |