amikacin sulfate · Insmed Inc · NDA 207356
Arikayce Kit
Earliest generic entry, as listed
15 May 2035
Blocked by patent: US 10251900, US 10751355, US 11446318, US 12016873, US 12168021, US 12168022, US 12377114, US 12616708, US 9895385. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 14 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10251900 | use U-2414 · sets the listed date | 15 May 2035 |
| US 10751355 | use U-2414 · sets the listed date | 15 May 2035 |
| US 11446318 | use U-2414 · sets the listed date | 15 May 2035 |
| US 12016873 | use U-2414 · sets the listed date | 15 May 2035 |
| US 12168021 | use U-2414 · sets the listed date | 15 May 2035 |
| US 12168022 | use U-2414 · sets the listed date | 15 May 2035 |
| US 12377114 | use U-2414 · sets the listed date | 15 May 2035 |
| US 12616708 | use U-2414 · sets the listed date | 15 May 2035 |
| US 9895385 | use U-2417 · sets the listed date | 15 May 2035 |
| US 9566234 | drug product, use U-2415 | 18 Jan 2034 |
| US 8226975 | drug product | 15 Aug 2028 |
| US 8632804 | use U-2416 | 5 Dec 2026 |
| US 8642075 | drug product | 5 Dec 2026 |
| US 8679532 | use U-2415 | 5 Dec 2026 |
Exclusivities · 1 unexpired
| GAIN | qualified infectious disease product | 28 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 |
|---|---|---|---|
| 207356 · 001 · RLD | suspension, liposomal, inhalation | EQ 590MG BASE/8.4ML | 15 May 2035 |
Expired or delisted (1)
- ODE-214 · 28 Sep 2025